Thread: FDA TYRANNY TO BECOME LAW

FDA TYRANNY TO BECOME LAW





By Byron J. Richards, CCN

July 12, 2007

NewsWithViews.com

On Wednesday, July11, 2007 the House passed HR.2900 without allowing the Ron Paul (R-TX) amendments to protect dietary supplements. Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company.

Both the House and Senate (S.1082) have made the fatally flawed assumption that the reason for so many deaths and injuries from drugs was due to the FDA’s lack of resources. In reality, it is the INTENTION of FDA management that is the problem, combined with the simple fact that multiple drugs are extremely toxic and don’t work as advertised. Giving the FDA more power and money will only cause the agency to speed more drugs onto the market faster with even less safety testing – while abusing its power and actively stamping out competition to drugs.

FDA management is in bed with Big Pharma and this new legislation makes matters significantly worse through the creation of the Reagan-Udall Foundation for the FDA. This new entity places the FDA in charge of drug design, drug patents, drug licenses, and the creation of new marketing entities/companies. Such a relationship with private industry is an unprecedented conflict of interest, totally at odds with drug safety. The current commissioner of the FDA, Andrew von Eschenbach, M.D. is little more than a Big Biotech sales rep with massive industry connections.

The House, like the Senate, will continue to allow direct to consumer advertising of new drugs with unknown risks – a flagrant safety risk that will cost many people their lives. Congressional leaders said they couldn’t prevent this advertisement for fear of violating the first amendment rights of drug companies. What a joke. The FDA routinely squashes the first amendment rights of American citizens to understand natural health options and the science that explains how they can prevent and treat disease. Thus, the first amendment argument is simply a matter of convenience. The FDA wants to actively suppress information that will help people, yet allow highly risky and misleading promotion of toxic substances often for untested uses. The FDA even wants to prevent citizens from suing drug companies when they are injured, thus protecting Big Pharma. FDA tyranny, based on this type of arbitrary and unrestrained exercise of power, is used to promote and protect the pharmaceutical industry while at the same time undermining the dietary supplement industry.

Both the House and Senate think it is completely fine that the drug industry pay the FDA fees so that the FDA can approve new drugs faster. Indeed, the FDA and Big Pharma met 112 times to work out their partnership before the FDA let Congress know what it wanted to see in HR.2900 and S.1082. This is like paying the mob for protection. A careful look at the history of the FDA shows it is little more than a bully that protects vested interests at the expense of human health. It is a pitiful agency. It is little wonder than the majority of Americans don’t trust the FDA.

Big Pharma owns the FDA and Congress. The drug industry sees FDA management and Congressional leaders as a training pool for future Big Pharma jobs – based on how well Big Pharma is supported. There will certainly be plenty of rewards to pass out after this legislation becomes law.

It is a sick situation that this new fake safety legislation provides the FDA with unprecedented new power to stamp out competition to drug companies as well as expose Americans to far greater safety risks than ever before. Provisions within the legislation that creates the Reagan-Udall Foundation for the FDA will allow the FDA to remove any dietary supplement from the market based on its whim.

It is now only a matter of time and a formality before HR.2900 and S.1082 become law. There will be a little bit of haggling in the conference committee, as Big Pharma will takes its last chance at watering down any meaningful reform (of which there is very little). Big Pharma will whine that this legislation is too tough on them, which is a fallacy. This legislation is the Big Pharma dream come true. In a football analogy the only question is the final score. Will Big Pharma win by 28-7 or will it win by 42-7. Big Pharma has just cleaned the clock of Americans. We should not forget the gutless Congressional puppets that made it happen.

A new tone has been set. A new chart has been plotted. Congress has transformed the FDA into a quasi drug company with unprecedented new regulatory power to control all health options in America. How many deaths and injuries will it take for a comatose and medicinally-overdosed public to wake up?

Related Articles:

1. How the FDA is Becoming a Drug Company, Part 1, 6-14-07
2. FDA Collaboration with Big Pharma Raises Eyebrows 6-7-07
3. Understanding the Threat to Dietary Supplements, Part 1, 5-15-07
4. Senators Chose Big Pharma Over the Best Interests of U.S. Citizens 5-9-07

© 2007 Truth in Wellness, LLC - All Rights Reserved

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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.

Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com

FREE Subscription to Byron's Health Newsletter, click here.

E-mail: byron@truthinwellness.com



http://www.newswithviews.com/Richards/byron38.htm

again, Ron Paul has the right of it,,,, and special interest/big business dug their claws in and passed some bogus big government bullsh#t!!!!!!!!!!!

BrightNail wrote:

again, Ron Paul has the right of it,,,, and special interest/big business dug their claws in and passed some bogus big government bullsh#t!!!!!!!

Don't be so quick to judge until you know all the details. I see a lot of opinion in the above article but very few specific details on the bill itself.

H.R. 2900: Food and Drug Administration Amendments Act of 2007

HR 2900 IH

110th CONGRESS

1st Session

H. R. 2900

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

June 28, 2007

Mr. DINGELL (for himself, Mr. BARTON of Texas, Mr. PALLONE, Mr. DEAL of Georgia, Mr. WAXMAN, Mr. BARROW, Mr. BUTTERFIELD, Mr. GONZALEZ, Mr. GENE GREEN of Texas, Mr. GORDON of Tennessee, Ms. SOLIS, Mr. MATHESON, Mr. INSLEE, Ms. ESHOO, Ms. HOOLEY, Ms. BALDWIN, Mr. FERGUSON, Mr. ENGEL, Mr. ROSS, Mr. TOWNS, Mr. ROGERS of Michigan, Mr. MARKEY, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. ALLEN, Mr. BURGESS, Mr. TERRY, Mrs. BONO, Mrs. MYRICK, Mrs. CAPPS, Mr. UPTON, Mr. MELANCON, and Mr. RUSH) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Food and Drug Administration Amendments Act of 2007'.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title.

Sec. 102. Definitions.

Sec. 103. Authority to assess and use drug fees.

Sec. 104. Fees relating to advisory review of prescription-drug television advertising.

Sec. 105. Reauthorization; reporting requirements.

Sec. 106. Sunset dates.

TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title.

Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.

Sec. 212. Authority to assess and use device fees.

Sec. 213. Annual reports.

Sec. 214. Consultation.

Sec. 215. Additional authorization of appropriations for postmarket safety information.

Sec. 216. Effective date.

Sec. 217. Sunset clause.

Subtitle B--Amendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket notification.

Sec. 222. Registration.

Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants; statements; accompanying disclosures.

Sec. 224. Electronic registration and listing.

Sec. 225. Report by Government Accountability Office.

Sec. 226. Unique device identification system.

Sec. 227. Frequency of reporting for certain devices.

Sec. 228. Inspections by accredited persons.

Sec. 229. Study of nosocomial infections relating to medical devices.

TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

Sec. 301. Short title.

Sec. 302. Tracking pediatric device approvals.

Sec. 303. Modification to humanitarian device exemption.

Sec. 304. Encouraging pediatric medical device research.

Sec. 305. Demonstration grants for improving pediatric device availability.

Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.

Sec. 307. Postmarket Studies.

TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.

Sec. 402. Reauthorization of Pediatric Research Equity Act.

Sec. 403. Government Accountability Office report.

TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.

Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.

TITLE VI--REAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration.

Sec. 602. Office of the Chief Scientist.

Sec. 603. Critical path public-private partnerships.

TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Clinical trial registry database and clinical trial results database.

Sec. 802. Study by Government Accountability Office.

TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk evaluation and mitigation strategies.

Sec. 902. Enforcement.

Sec. 903. No effect on withdrawal or suspension of approval.

Sec. 904. Benefit-risk assessments.

Sec. 905. Postmarket risk identification and analysis system for active surveillance and assessment.

Sec. 907. Statement for inclusion in direct-to-consumer advertisements of drugs.

Sec. 908. Clinical trial guidance for antibiotic drugs.

Sec. 909. Prohibition against food to which drugs or biological products have been added.

Sec. 910. Assuring pharmaceutical safety.

Sec. 911. Orphan antibiotic drugs.

Sec. 912. Authorization of appropriations.

Sec. 913. Effective date and applicability.

TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

(a) Short Title- This title may be cited as the `Prescription Drug User Fee Amendments of 2007'.

(b) References in Act- Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 102. DEFINITIONS.

Section 735 (21 U.S.C. 379g) is amended--

(1) in paragraph (1)--

(A) in subparagraph (A), by striking `505(b)(1),' and inserting `505(b), or';

(B) by striking subparagraph (B); and

(C) by redesignating subparagraph (C) as subparagraph (B);

(2) in paragraph (3)(C)--

(A) by striking `505(j)(7)(A)' and inserting `505(j)(7)(A) (not including the discontinued section of such list),'; and

(B) by inserting before the period `(not including the discontinued section of such list)';

(3) in paragraph (4), by inserting before the period at the end the following: `(such as capsules, tablets, or lyophilized products before reconstitution)';

(4) by amending paragraph (6)(F) to read as follows:

`(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:

`(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

`(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

`(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

`(iv) Preparing and making publicly available (including on the website of the Food and Drug Administration) a summary analysis of the adverse drug reaction reports received for recently approved drugs, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number not previously identified within 18 months of the drug's initial marketing or after exposure of 10,000 individuals to the drug, whichever is later.

`(v) Conducting regular, bi-weekly screening of the Adverse Event Reporting System database and developing a report every 15 days on any new safety concerns.

`(vi) Ensuring that the reports available to the public under the Adverse Event Reporting System are updated at least every 6 months.

`(vii) Reporting to the Congress on--

`(I) the recommendations received in consultations with, and reports from, the Office of Surveillance and Epidemiology within the Food and Drug Administration on postmarket safety activities;

`(II) a description of the actions taken on those recommendations; and

`(III) if no action is taken, or a different action is taken relative to the action recommended by the Office of Surveillance and Epidemiology, an explanation of why no action or a different action was taken.

`(viii) On an annual basis, reviewing the entire backlog of postmarket safety commitments to determine which commitments require revision or should be eliminated, reporting to the Congress on these determinations, and assigning start dates and estimated completion dates for such commitments.

`(ix) Developing postmarket safety performance measures, including those listed in clauses (iv) through (viii), that are as measurable and rigorous as the ones already developed for premarket review.';

(5) in paragraph (--

(A) by striking `April of the preceding fiscal year' and inserting `October of the preceding fiscal year'; and

(B) by striking `April 1997' and inserting `October 1996';

(6) by redesignating paragraph (9) as paragraph (11); and

(7) by inserting after paragraph ( the following paragraphs:

`(9) The term `person' includes an affiliate thereof.

`(10) The term `active', with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.'.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) Types of Fees- Section 736(a) (21 U.S.C. 379h(a)) is amended--

(1) in the matter preceding paragraph (1), by striking `2003' and inserting `2008';

(2) in paragraph (1)--

(A) in subparagraph (D)--

(i) in the heading, by inserting `OR WITHDRAWN BEFORE FILING' after `REFUSED FOR FILING'; and

(ii) by inserting before the period at the end the following: `or withdrawn without a waiver before filing';

(B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and

(C) by inserting after subparagraph (D) the following:

`(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR FILING OR WITHDRAWN BEFORE FILING- A human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).'; and

(3) in paragraph (2)--

(A) in subparagraph (A), by striking `subparagraph (B)' and inserting `subparagraphs (B) and (C)'; and

(B) by adding at the end the following:

`(C) SPECIAL RULES FOR POSITRON EMISSION TOMOGRAPHY DRUGS-

`(i) IN GENERAL- Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application.

`(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT FEE- Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that--

`(I) the person is a not-for-profit medical center that has only 1 establishment for the production of positron emission tomography drugs; and

`(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.

`(iii) DEFINITION- For purposes of this subparagraph, the term `positron emission tomography drug' has the meaning given to the term `compounded positron emission tomography drug' in section 201(ii), except that subparagraph (1)(B) of such section shall not apply.'.

(b) Fee Revenue Amounts- Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows:

`(b) Fee Revenue Amounts-

`(1) IN GENERAL- For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of--

`(A) $392,783,000; and

`(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).

`(2) TYPES OF FEES- Of the total revenue amount determined for a fiscal year under paragraph (1)--

`(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements);

`(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and

`(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products).

`(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL YEAR 2007- For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12-month period for which data on such submissions is available.

`(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY-

`(A) IN GENERAL- For each of the fiscal years 2008 through 2012, paragraph (1)(A) shall, subject to subparagraph (C), be applied by substituting the amount determined under subparagraph (B) for `$392,783,000'.

`(B) AMOUNT DETERMINED- For each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of--

`(i) $392,783,000; plus

`(ii) an amount equal to--

`(I)(aa) for fiscal year 2008, $25,000,000;

`(bb) for fiscal year 2009, $35,000,000;

`(cc) for fiscal year 2010, $45,000,000;

`(dd) for fiscal year 2011, $55,000,000; and

`(ee) for fiscal year 2012, $65,000,000; minus

`(II) the amount equal to the excess amount in item (bb), provided that--

`(aa) the amount of the total appropriation for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriation for the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1); and

`(bb) the amount of the total appropriations for the process of human drug review at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations for the process of human drug review at the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1).

In making the adjustment under subclause (II) for any of fiscal years 2008 through 2012, subsection (c)(1) shall be applied by substituting `2007' for `2008'.

`(C) LIMITATION- This paragraph shall not apply for any fiscal year if the amount described under subparagraph (B)(ii) is less than 0.'.

(c) Adjustments to Fees-

(1) INFLATION ADJUSTMENT- Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended--

(A) in the matter preceding subparagraph (A), by striking `The revenues established in subsection (b)' and inserting `For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)';

(B) in subparagraph (A), by striking `or' at the end;

(C) in subparagraph (B), by striking the period at the end and inserting `, or';

(D) by inserting after subparagraph (B) the following:

`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.'; and

(E) in the matter following subparagraph (C) (as added under this paragraph), by striking `fiscal year 2003' and inserting `fiscal year 2008'.

(2) WORKLOAD ADJUSTMENT- Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended--

(A) in the matter preceding subparagraph (A), by striking `Beginning with fiscal year 2004,' and inserting `For fiscal year 2009 and subsequent fiscal years,';

(B) in subparagraph (A), in the first sentence--

(i) by striking `human drug applications,' and inserting `human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),';

(ii) by striking `commercial investigational new drug applications,'; and

(iii) by inserting before the period the following: `, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available';

(C) in subparagraph (B), by adding at the end the following: `Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.'; and

(D) by adding at the end the following:

`(C) The Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been completed.'.

(3) RENT AND RENT-RELATED COST ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended--

(A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and

(B) by inserting after paragraph (2) the following:

`(3) RENT AND RENT-RELATED COST ADJUSTMENT- For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed $11,721,000 for any fiscal year.'.

(4) FINAL YEAR ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended--

(A) in paragraph (4) (as redesignated by paragraph (3)(A))--

(i) by striking `2007' each place it appears and inserting `2012';

(ii) by striking `paragraphs (1) and (2)' and inserting `paragraphs (1), (2), and (3)'; and

(iii) by striking `2008' and inserting `2013'; and

(B) in paragraph (5) (as so redesignated), by striking `2002' and inserting `2007'.

(d) Fee Waiver or Reduction- Section 736(d) (21 U.S.C. 379h(d)) is amended--

(1) in paragraph (1), in the matter preceding subparagraph (A)--

(A) by inserting after `The Secretary shall grant' the following: `to a person who is named as the applicant in a human drug application'; and

(B) by inserting `to that person' after `one or more fees assessed';

(2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

(3) by inserting after paragraph (1) the following:

`(2) CONSIDERATIONS- In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.'; and

(4) in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the period the following: `, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce'.

(e) Crediting and Availability of Fees-

(1) AUTHORIZATION OF APPROPRIATIONS- Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows:

`(3) AUTHORIZATION OF APPROPRIATIONS- For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4) of this subsection.'.

(2) OFFSET- Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows:

`(4) OFFSET- If the sum of the cumulative amount of fees collected under this section for the fiscal years 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.'.

(f) Exemption for Orphan Drugs- Section 736 (21 U.S.C. 379h) is further amended by adding at the end the following:

`(k) Orphan Drugs- A drug designated under section 526 for a rare disease or condition and approved under section 505 or under section 351 of the Public Health Service Act shall be exempt from product and facility fees under this section, provided that the drug meets all of the following:

`(1) The drug had United States sales in the previous year of less than $25,000,000 for the active moiety, for all indications, dosage forms, and strengths for which the drug is approved and for any off-label uses.

`(2) The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and facility fees.

`(3) The drug is owned or licensed and marketed by a company that had less than $100,000,000 in gross worldwide revenue during the previous year.'.

(g) Conforming Amendment- Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking `(c)(4)' each place such term appears and inserting `(c)(5)'.

SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG TELEVISION ADVERTISING.

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following:

`SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG TELEVISION ADVERTISING.

`(a) Types of Direct-to-Consumer Television Advertisement Review Fees- Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:

`(1) ADVISORY REVIEW FEE-

`(A) IN GENERAL- With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a `DTC advertisement'), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public broadcast (referred to in this section as `prebroadcast advisory review') shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).

`(B) EXCEPTION FOR REQUIRED SUBMISSIONS- A DTC advertisement that is required under section 502(n) to be submitted to the Secretary prior to initial public broadcast is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for prebroadcast advisory review.

`(C) NOTICE TO SECRETARY OF NUMBER OF ADVERTISEMENTS- Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for prebroadcast advisory review in the next fiscal year.

`(D) PAYMENT-

`(i) IN GENERAL- The fee required by subparagraph (A) (referred to in this section as `an advisory review fee') shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended be submitted for prebroadcast advisory review, subject to subparagraph (F)(i).

`(ii) EFFECT OF SUBMISSION- Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for prebroadcast advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted.

`(iii) NOTICE REGARDING CARRYOVER SUBMISSIONS- In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for prebroadcast advisory review in the fiscal year involved shall be subject to the advisory review fee.

`(E) MODIFICATION OF ADVISORY REVIEW FEE-

`(i) LATE PAYMENT- If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) on or before November 1 of such fiscal year, the fees are regarded as late and a revised due date and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, the advisory review fee for each DTC advertisement submitted in such fiscal year for prebroadcast advisory review shall be due and payable 20 days before the advertisement is submitted to the Secretary, and each such fee shall be revised to be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

`(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMISSIONS- If a person submits a number of DTC ads for prebroadcast advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), a revised due date and an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC ad, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be revised to be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

`(F) LIMITS-

`(i) SUBMISSIONS- For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.

`(ii) NO REFUNDS- Except as provided by subsection (f), fees paid under subparagraph (A) shall not be refunded.

`(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS- The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.

`(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFERABLE- The right to an advisory review under this paragraph is not transferable, except to a successor in interest.

`(2) OPERATING RESERVE FEE-

`(A) IN GENERAL- Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee established under subsection (d)(2) referred to in this section as an `operating reserve fee' for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.

`(B) PAYMENT- Except as provided in subparagraph (C), the operating reserve fee shall be due no later than October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1).

`(C) LATE NOTICE OF SUBMISSION- If, in the first fiscal year of a person's participation in the program under this section, that person submits any DTC advertisements for prebroadcast advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(D)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for prebroadcast advisory review.

`(b) Advisory Review Fee Revenue Amounts- Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).

`(c) Adjustments-

`(1) INFLATION ADJUSTMENT- Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of--

`(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

`(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.

`(2) WORKLOAD ADJUSTMENT- Beginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial broadcast. With respect to such adjustment:

`(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

`(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.

`(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW-

`(A) IN GENERAL- Not later than August 1 of each fiscal year, the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions.

`(B) FISCAL YEAR 2008 FEE LIMIT- Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.

`(C) ANNUAL FEE LIMIT- Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.

`(D) LIMIT- The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.

`(d) Operating Reserves-

`(1) IN GENERAL- The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.

`(2) FEE SETTING- The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.

`(3) USE OF OPERATING RESERVE- The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.

`(4) REFUND OF OPERATING RESERVES- Within 120 days of the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).

`(e) Effect of Failure To Pay Fees- Notwithstanding any other requirement, a submission for prebroadcast advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.

`(f) Effect of Inadequate Funding of Program-

`(1) INITIAL FUNDING- If on November 1, 2007, or 120 days after enactment of this provision, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.

`(2) LATER FISCAL YEARS- Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall cease to exist, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to close down the program under this section, and refund the remainder of the unused fees and operating reserves. To the extent required to close down the program under this section, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.

`(g) Crediting and Availability of Fees-

`(1) IN GENERAL- Fees authorized under subsection (a) of this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.

`(2) COLLECTIONS AND APPROPRIATION ACTS-

`(A) IN GENERAL- The fees authorized by this section--

`(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

`(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.

`(B) REVIEW EMPLOYEES- For purposes of subparagraph (A)(ii), the term `full-time equivalent review employees' means the total combined number of full-time equivalent employees in--

`(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and

`(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

`(3) AUTHORIZATION OF APPROPRIATIONS- For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).

`(4) OFFSET- Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.

`(h) Definitions- For purposes of this subchapter:

`(1) The term `advisory review' means reviewing and providing advisory comments on a proposed advertisement prior to its initial public broadcast.

`(2) The term `advisory review fee' has the meaning indicated for such term in subsection (a)(1)(D).

`(3) The term `carry over submission' means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.

`(4) The term `direct-to-consumer television advertisement' means an advertisement for a prescription drug product as defined in section 735(3) intended to be displayed on any television channel for less than 3 minutes.

`(5) The term `DTC advertisement' has the meaning indicated for such term in subsection (a)(1)(A).

`(6) The term `operating reserve fee' has the meaning indicated for such term in subsection (a)(2)(A).

`(7) The term `person' includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.

`( The term `prebroadcast advisory review' has the meaning indicated for such term in subsection (a)(1)(A).

`(9) The term `process for the advisory review of prescription drug advertising' means the activities necessary to review and provide advisory comments on DTC advertisements prior to public broadcast and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public broadcast.

`(10) The term `resources allocated for the process for the advisory review of prescription drug advertising' means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for--

`(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;

`(B) management of information, and the acquisition, maintenance, and repair of computer resources;

`(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;

`(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and

`(E) closing down the program under this section pursuant to subsection (f)(2) if that becomes necessary.

`(11) The term `resubmission' means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.

`(12) The term `submission for advisory review' means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.'.

SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.

(a) Performance Report- Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services (referred to in this section as the `Secretary') shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) of the Prescription Drug User Fee Amendments of 2002 (Subtitle A of title V of Public Law 107-18 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(b) Fiscal Report- Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under the part described in subsection (a), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Reauthorization-

(1) CONSULTATION- In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with--

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) PUBLIC REVIEW OF RECOMMENDATIONS- After negotiations with the regulated industry and representatives of patient and consumer advocacy groups, the Secretary shall--

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(3) TRANSMITTAL OF RECOMMENDATIONS- Not later than January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(4) PUBLIC AVAILABILITY OF MINUTES- Before presenting the recommendations developed under paragraphs (1) and (2) to the Congress, the Secretary shall make publicly available, on the public website of the Food and Drug Administration, the minutes of all negotiations conducted under paragraph (1) or (2), as applicable, between the Food and Drug Administration and the regulated industry and representatives of patient and consumer advocacy groups.

SEC. 106. SUNSET DATES.

The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.

TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

SEC. 201. SHORT TITLE; REFERENCES IN TITLE.

(a) Short Title- This title may be cited as the `Medical Device User Fee Amendments of 2007'.

(b) References in Act- Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

Subtitle A--Fees Related to Medical Devices

SEC. 211. DEFINITIONS.

Section 737 (21 U.S.C. 379i) is amended--

(1) in paragraph (4)--

(A) in subparagraph (A), by striking `or an efficacy supplement,' and inserting `an efficacy supplement, or a 30-day notice,'; and

(B) by adding after subparagraph (E) the following:

`(F) The term `30-day notice' means a supplement to an approved premarket application or premarket report under section 515 that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.';

(2) by redesignating paragraphs (5), (6), (7), and ( as paragraphs (7), (, (9), and (11), respectively;

(3) by inserting after paragraph (4), as amended by paragraph (1) of this section, the following:

`(5) The term `request for classification information' means a request made under section 513(g) for information respecting the class in which a device has been classified or the requirements applicable to a device.

`(6) The term `annual fee', with respect to periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a PMA approval order (as described in section 814.82(a)(7) of title 21, Code of Federal Regulations (or any successor regulation)).';

(4) in paragraph (9), as so redesignated--

(A) by striking `April of the preceding fiscal year' and inserting `October of the preceding fiscal year'; and

(B) by striking `April 2002' and inserting `October 2001';

(5) by inserting after paragraph (9), as so amended, the following:

`(10) The term `person' includes an affiliate thereof.'; and

(6) by inserting after paragraph (11), as redesignated by paragraph (2) of this section, the following:

`(12) The term `establishment subject to registration' means an establishment that is required to register with the Secretary under section 510 and is one of the following types of establishments:

`(A) MANUFACTURER- An establishment that makes by any means any article that is a device, as defined in section 201(h), including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person.

`(B) SINGLE-USE DEVICE REPROCESSOR- An establishment that performs manufacturing operations on a single-use device.

`(C) SPECIFICATION DEVELOPER- An establishment that develops specifications for a device that is distributed under the establishment's name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.'.

SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.

(a) Types of Fees-

(1) IN GENERAL- The designation and heading of paragraph (2) of section 738(a) (21 U.S.C. 379j(a)(2)) are amended to read as follows:

`(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLEMENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC REPORTING CONCERNING A CLASS III DEVICE- '.

(2) FEE AMOUNTS- Section 738(a)(2)(A) (21 U.S.C. 379j(a)(2)(A)) is amended--

(A) in clause (iii), by striking `a fee equal to the fee that applies' and inserting `a fee equal to 75 percent of the fee that applies';

(B) in clause (iv), by striking `21.5 percent' and inserting `15 percent';

(C) in clause (v), by striking `7.2 percent' and inserting `7 percent';

(D) by redesignating clauses (vi) and (vii) as clauses (vii) and (viii), respectively;

(E) by inserting after clause (v), as amended by this paragraph, the following:

`(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).';

(F) in clause (viii), as so redesignated, by striking `1.42 percent' and inserting `1.84 percent'; and

(G) by inserting after such clause (viii) the following:

`(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

`(x) For periodic reporting concerning a class III device, the annual fee shall be equal to 3.5 percent of the fee that applies under clause (i).'.

(3) PAYMENT- Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) is amended to read as follows:

`(C) PAYMENT- The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to section 515(c)(3) shall pay such fees upon submission of the first portion of such applications.'.

(4) REFUNDS- Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) is amended by adding after clause (iii) the following:

`(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE FIRST ACTION- The Secretary shall refund 75 percent of the application fee paid for a modular application submitted under section 515(c)(4) that is withdrawn before a second module is submitted and before a first action on the first module. If the modular application is withdrawn after a second or subsequent module is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the modules submitted.'.

(5) ANNUAL ESTABLISHMENT REGISTRATION FEE- Section 738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) the following:

`(3) ANNUAL ESTABLISHMENT REGISTRATION FEE-

`(A) IN GENERAL- Except as provided in subparagraph (B), each establishment subject to registration shall be subject to a fee for each initial or annual registration under section 510 beginning with its registration for fiscal year 2008.

`(B) EXCEPTION- No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act), unless a device manufactured by the establishment is to be distributed commercially.

`(C) PAYMENT- The fee required under subparagraph (A) shall be due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.'.

(b) Fee Amounts- Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows:

`(b) FEE AMOUNTS- Except as provided in subsections (c), (d), and (e), the fees under subsection (a) shall be based on the following fee amounts:

--------------------------------------------------------------------------------
Fee Type Fiscal Year 2008 Fiscal Year 2009 Fiscal Year 2010 Fiscal Year 2011 Fiscal Year 2012
--------------------------------------------------------------------------------
Premarket Application $185,000 $200,725 $217,787 $236,298 $256,384
Establishment Registration $1,706 $1,851 $2,008 $2,179 $2,364.'.
--------------------------------------------------------------------------------

(c) Annual Fee Setting-

(1) IN GENERAL- Section 738(c) (21 U.S.C. 379j(c)(1)) is amended--

(A) in the subsection heading, by striking `Annual Fee Setting' and inserting `Annual Fee Setting'; and

(B) in paragraph (1), by striking the last sentence.

(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE- Section 738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is further amended--

(A) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

(B) by inserting after paragraph (1) the following:

`(2) ADJUSTMENT-

`(A) IN GENERAL- When setting fees for fiscal year 2010, the Secretary may increase the fee under subsection (a)(3)(A) (applicable to establishments subject to registration) only if the Secretary estimates that the number of establishments submitting fees for fiscal year 2009 is less than 12,250. The percentage increase shall be the percentage by which the estimate of establishments submitting fees in fiscal year 2009 is less than 12,750, but in no case may the percentage increase be more than 8.5 percent over that specified in subsection (b) for fiscal year 2010. If the Secretary makes any adjustment to the fee under subsection (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that such fee for fiscal year 2011 is equal to the adjusted fee for fiscal year 2010 increased by 8.5 percent, and such fee for fiscal year 2012 is equal to the adjusted fee for fiscal year 2011 increased by 8.5 percent.

`(B) PUBLICATION- For any adjustment made under subparagraph (A), the Secretary shall publish in the Federal Register the Secretary's determination to make the adjustment and the rationale for the determination.'; and

(C) in paragraph (4), as redesignated by this paragraph, in subparagraph (A)--

(i) by striking `For fiscal years 2006 and 2007, the Secretary' and inserting `The Secretary'; and

(ii) by striking `for the first month of fiscal year 2008' and inserting `for the first month of the next fiscal year'.

(d) Small Businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval-

(1) IN GENERAL- Section 738(d)(1) (21 U.S.C. 379j(d)(1)) is amended--

(A) by striking `, partners, and parent firms'; and

(B) by striking `clauses (i) through (vi) of subsection (a)(2)(A)' and inserting `clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)'.

(2) RULES RELATING TO PREMARKET APPROVAL FEES-

(A) DEFINITION- Section 738(d)(2)(A) (21 U.S.C. 379j(d)(2)(A)) is amended by striking `, partners, and parent firms'.

(B) EVIDENCE OF QUALIFICATION- Section 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended--

(i) by striking `(B) EVIDENCE OF QUALIFICATION- An applicant' and inserting the following:

`(B) EVIDENCE OF QUALIFICATION-

`(i) IN GENERAL- An applicant';

(ii) by striking `The applicant shall support its claim' and inserting the following:

`(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE- The applicant shall support its claim';

(iii) by striking `, partners, and parent firms' each place it appears;

(iv) by striking the last sentence and inserting `If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.'; and

(v) by adding at the end the following:

`(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE- In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts and sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts and sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.'.

(3) REDUCED FEES- Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:

`(C) REDUCED FEES- Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of--

`(i) `(i) 25 perc

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