[Congressional Record Volume 143, Number 129 (Wednesday, September 24, 1997)]
[Senate]
[Pages S9847-S9868]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The Senate continued with the consideration of the bill.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. How much time remains, Mr. President?

[[Page S9848]]

  The PRESIDING OFFICER. The Senator from Massachusetts has 7 minutes.
  Mr. KENNEDY. Mr. President, I yield myself 3 minutes.
  Just a short while ago, we heard some comments on the floor about how 
this whole process has taken a long period of time. It has taken a 
period of time. But I think one can see from any fair review of the 
history of the legislation that very substantial progress has been made 
in making this a better bill. As I pointed out earlier in the debate, 
of the 20 major health safety issues identified by the administration, 
19 have been addressed, not only in our committee markup, but also in 
the negotiations that we had prior to the time of the legislation 
coming to the floor. There is the one remaining item, which deals with 
safety and medical devices. It is extremely important. We have given 
focus to this issue because it deserves the focus that we have given 
it.
  Mr. President, I have in my hand the statement of the administration 
policy. It indicates that it has two major concerns with the bill. One 
is the technical provision with regard to the budget agreement and how 
they are going to allocate to PDUFA, which is a technical issue. But 
the other issue mentioned by the administration is this particular 
provision:

       First, section 404 of the bill would lower the review 
     standard for marketing approval by precluding the FDA from 
     reviewing medical devices for uses other than those for which 
     the manufacturer says they are intended.

  The administration indicates, as they did in the letter in September, 
as they did in June, that this particular provision is dangerous in 
terms of the consumers in this country.
  We have reviewed, over the course of the debate, the dangerous 
situations that have been the result of medical device disasters. We 
are committed to avoiding that kind of disaster in the future. We have 
a good safety record at the present time, but we are endangering that 
record with section 404. We noted that virtually every consumer group 
supports changing section 404. It is enormously important. It goes to 
the fundamental question of providing FDA with the power and authority 
to pursue the protections of the American health in the area of medical 
devices.
  Mr. President, I ask unanimous consent that the statement of the 
administration policy supporting our position regarding 404 be printed 
in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         Executive Office of the President, Office of Management 
           and Budget,
                               Washington, DC, September 24, 1997.

                   Statement of Administration Policy

    (This statement has been coordinated by OMB with the concerned 
                               agencies.)


        S. 830--FDA Modernization and Accountability Act of 1997

                       (Senator Jeffords (R) VT)

       The Administration applauds the Senate for its bipartisan 
     effort to improve S. 830 since it was reported by the Senate 
     Committee on Labor and Human Resources, and appreciates the 
     Senate's responsiveness to concerns that have been raised. 
     Because of the importance of obtaining a five-year extension 
     of the Prescription Drug User Fee Act (PDUFA), the 
     Administration has no objection to passage of the bill by the 
     Senate at this time. However, the Administration finds that 
     the provisions identified below are unacceptable and as the 
     legislative process continues, will work to ensure that our 
     remaining concerns are resolved.
       In general, this legislation represents a significant step 
     toward accomplishing our mutual goal of assuring the agency's 
     optimum performance while protecting the health of the 
     American public. The Administration, however, continues to 
     have two major concerns with the bill.
       First, section 404 of the bill would lower the review 
     standard for marketing approval by precluding the Food and 
     Drug Administration (FDA) from reviewing new medical devices 
     for uses other than those for which the manufacturer says 
     they are intended. Second, the PDUFA trigger as proposed in 
     S. 830 undercuts the bipartisan budget agreement (BBA) by 
     requiring budget increases for FDA not envisioned by the BBA, 
     and would interfere with HHS' ability to allocate resources 
     appropriately throughout the Department.
       In order to be able to support the final bill, the 
     Administration will continue to work with the House of 
     Representatives and in conference to resolve these and other 
     identified issues.

  Mr. KENNEDY. We hope that we can be convincing as this legislation 
goes forward. We have not been convincing here on the floor. We hope 
provisions can be accepted that will make 404 acceptable in terms of 
the public health issues. I want to express my sincere appreciation to 
the chairman of the committee, Senator Jeffords, who has been a 
chairman's chair. He is strong in his belief. He is a fighter for the 
things that he champions. He has been willing to accommodate differing 
views. He protects his strong posture and positions on his own views, 
and I respect that. I thank the other Members of this body for their 
courtesy during the course of what I know has been a continuing 
discussion and debate on a very important measure. I thank all of our 
Members for their courtesy and consideration as we move toward a vote 
on this legislation. I thank my chairman.
  At the time when the Senator from Vermont is prepared to yield back 
his time, I will be prepared to do so likewise and move to our vote.


                       unanimous-consent request

  Mr. JEFFORDS. Mr. President, first, I have a unanimous-consent 
request, which has been cleared on both sides.
  I ask unanimous consent that it be in order to consider amendment No. 
1184, as modified, with changes that are at the desk; further, that the 
amendment be agreed to, and the motion to reconsider be laid upon the 
table.
  I'm sorry, Mr. President, I withdraw that request at this moment.
  The PRESIDING OFFICER. It is withdrawn.
  Mr. JEFFORDS. Mr. President, first of all, I thank the ranking member 
for his help on this bill. We agree on 19 out of 20 provisions. His 
steadfast and articulate objection to the 20th, relative to section 
404, has been done sincerely and very well done on that issue. I 
believe that we have a good bill, but we remain open to suggestions, as 
always, as to how the bill can be improved. I am extremely pleased that 
the Senate has overwhelmingly approved S. 830 yesterday. I believe this 
is an important step forward for ensuring a stronger and more efficient 
FDA.
  Throughout this process, we have had the benefit of input from all 
interested parties on how best to modernize the Agency, while ensuring 
that its stellar standard for public safety remains as strong as ever. 
I am extremely proud of the strong support of this legislation 
expressed by the health community. For instance, the National Health 
Council, a coalition of over 100 health and patient organizations, has 
urged the Senate to move forward with this legislation. We have also 
received support from physician groups, including the American Medical 
Association and the American Academy of Pediatrics.
  We must remember that drugs and medical devices delayed at the FDA 
are often lives lost. When cardiac defibrillators were first developed 
in the late 1980's, they brought new hope and opportunity to many of 
the 350,000 Americans who would otherwise suffer sudden cardiac death 
each year.

  But the first version of this technology required opening the chest 
and separating the ribs to apply this technology to the heart. This 
procedure carried a 4.2 percent mortality rate.
  Improvements to this defibrillator technology were widely available 
in Europe two years before patients could benefit in this country. The 
new technology did not require cracking the patients chest, but only a 
small incision to allow the technology to be threaded through a vein 
into the heart.
  During this unnecessary 2-year delay, it is estimated that 1,056 
Americans died from complications related to the more invasive 
technique. Delay does cost lives.
  And far from allowing dangerous products on the market as Senator 
Kennedy has alleged, section 404 of this bill keeps intact FDA's 
authority to investigate technological issues which raise new safety 
and effectiveness questions, does not limit FDA's enforcement 
authority, and does not touch FDA's regulations which require that 
medical device applications be truthful and not omit any material 
facts.

[[Page S9849]]

  Section 404 does quite appropriately keep FDA out of regulating the 
practice of medicine. That is important and we should fight to protect 
the intent of this provision.
  Patients will also benefit from other provisions of the bill 
including the registry of clinical trials, fast-track approval for 
drugs treating life-threatening diseases, expanded access to 
investigational therapies, and the incentives established to 
investigate pediatric uses of drugs.
  I want to thank the patient, consumer, and physician groups, and all 
the others we have worked with, for their commitment to working toward 
real reforms that strengthen the FDA and the contributions they have 
made in crafting this bipartisan measure.
  Mr. President, how much time do I have left?
  The PRESIDING OFFICER. The Senator from Vermont has 9 minutes 
remaining.
  Mr. JEFFORDS. I yield 2 minutes to the Senator from Florida.
  The PRESIDING OFFICER. The Senator from Florida is recognized.
  Mr. MACK. Mr. President, I thank Senator Jeffords for yielding.
  First of all, I want to commend him for a tremendous amount of work. 
This is an incredibly complicated piece of legislation. It has involved 
a lot of different interest groups in some issues that have become very 
charged.
  So I again want to thank the Senator from Vermont for his willingness 
to work with Senator Frist and I as we worked on the so-called off-
label issue.
  I also want to express my appreciation to Senator Kennedy. He had 
some deep concerns about the legislation, and as a result of extensive 
discussions we were able to find a compromise. I think it was one of 
the reasons that this bill was able to move forward.
  So I thank Senator Jeffords and Senator Kennedy. And I also want to 
put in a comment with respect to Mark Smith, my staffer who has worked 
on this issue for more than some 2\1/2\ years.
  Again, I thank Senator Jeffords for what he has done.
  Mr. JEFFORDS. I thank the Senator for his comments, and I want to 
praise him for his efforts with respect to off-label. This is an 
incredibly important amendment that Senator Mack and Senator Frist have 
worked out with the FDA and the minority. That is going to give a great 
deal of assistance to people in this country who are in need of help in 
straightening out a relatively difficult area with such preciseness. 
The Senator from Florida did a good job.


                    Amendment No. 1184, As Modified

  Mr. President, I ask unanimous consent that it be in order to 
consider amendment No. 1184, as modified, with changes that are at the 
desk; further, that the amendment be agreed to, and the motion to 
reconsider be laid upon the table.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  The amendment (No. 1184), as modified, was agreed to, as follows:
       Strike section 809 and insert the following:

     SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF 
                   PHARMACY COMPOUNDING.

       Section 503 (21 U.S.C. 353) is amended by adding at the end 
     the following:
       ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 
     507 shall not apply to a drug product if--
       ``(A) the drug product is compounded for an identified 
     individual patient, based on a medical need for a compounded 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, on the 
     prescription order of a licensed physician or other licensed 
     practitioner authorized by State law to prescribe drugs; or
       ``(ii) by a licensed pharmacist or licensed physician in 
     limited quantities, prior to the receipt of a valid 
     prescription order for the identified individual patient, and 
     is compounded based on a history of the licensed pharmacist 
     or licensed physician receiving valid prescription orders for 
     the compounding of the drug product that have been generated 
     solely within an established relationship between the 
     licensed pharmacist, or licensed physician, and--
       ``(I) the individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order; and
       ``(B) the licensed pharmacist or licensed physician--
       ``(i) compounds the drug product using bulk drug 
     substances--
       ``(I) that--

       ``(aa) comply with the standards of an applicable United 
     States Pharmacopeia or National Formulary monograph; or
       ``(bb) in a case in which such a monograph does not exist, 
     are drug substances that are covered by regulations issued by 
     the Secretary under paragraph (3);

       ``(II) that are manufactured by an establishment that is 
     registered under section 510 (including a foreign 
     establishment that is registered under section 510(i)); and
       ``(III) that are accompanied by valid certificates of 
     analysis for each bulk drug substance;
       ``(ii) compounds the drug product using ingredients (other 
     than bulk drug substances) that comply with the standards of 
     an applicable United States Pharmacopeia or National 
     Formulary monograph and the United States Pharmacopeia 
     chapter on pharmacy compounding;
       ``(iii) only advertises or promotes the compounding service 
     provided by the licensed pharmacist or licensed physician and 
     does not advertise or promote the compounding of any 
     particular drug, class of drug, or type of drug;
       ``(iv) does not compound a drug product that appears on a 
     list published by the Secretary in the Federal Register of 
     drug products that have been withdrawn or removed from the 
     market because such drug products or components of such drug 
     products have been found to be unsafe or not effective;
       ``(v) does not compound a drug product that is identified 
     by the Secretary in regulation as presenting demonstrable 
     difficulties for compounding that reasonably demonstrate an 
     adverse effect on the safety or effectiveness of that drug 
     product; and
       ``(vi) does not distribute compounded drugs outside of the 
     State in which the drugs are compounded, unless the principal 
     State agency of jurisdiction that regulates the practice of 
     pharmacy in such State has entered into a memorandum of 
     understanding with the Secretary regarding the regulation of 
     drugs that are compounded in the State and are distributed 
     outside of the State, that provides for appropriate 
     investigation by the State agency of complaints relating to 
     compounded products distributed outside of the State.
       ``(2)(A) The Secretary shall, after consultation with the 
     National Association of Boards of Pharmacy, develop a 
     standard memorandum of understanding for use by States in 
     complying with paragraph (1)(B)(vi).
       ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed 
     pharmacist or licensed physician, who does not distribute 
     inordinate amounts of compounded products outside of the 
     State, until--
       ``(i) the date that is 180 days after the development of 
     the standard memorandum of understanding; or
       ``(ii) the date on which the State agency enters into a 
     memorandum of understanding under paragraph (1)(B)(vi),
     whichever occurs first.
       ``(3) The Secretary, after consultation with the United 
     States Pharmacopeia Convention Incorporated, shall promulgate 
     regulations limiting compounding under paragraph 
     (1)(B)(i)(I)(bb) to drug substances that are components of 
     drug products approved by the Secretary and to other drug 
     substances as the Secretary may identify.
       ``(4) The provisions of paragraph (1) shall not apply--
       ``(A) to compounded positron emission tomography drugs as 
     defined in section 201(ii); or
       ``(B) to radiopharmaceuticals.
       ``(5) In this subsection, the term `compound' does not 
     include to mix, reconstitute, or perform another similar act, 
     in accordance with directions contained in approved drug 
     labeling provided by a drug manufacturer and other drug 
     manufacturer directions consistent with that labeling.''.

  Mr. JEFFORDS. Mr. President, I ask unanimous consent that Senator 
Abraham be added as a cosponsor of S. 830.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Mr. President, if the minority is ready and will yield 
all remaining time, I will yield mine.
  It is my understanding the minority will yield this time. I yield the 
remainder of my time.
  The PRESIDING OFFICER. Without objection, the minority time is 
yielded.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the 
administration policy that was received as a message be printed in the 
Record.
  I thank them for bringing it to our attention at this time.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         Executive Office of the President, Office of Management, 
           and Budget,
                               Washington, DC, September 24, 1997.

                   Statement of Administration Policy


    (THIS STATEMENT HAS BEEN COORDINATED BY OMB WITH THE CONCERNED 
                               AGENCIES.)

        S. 830--FDA Modernization and Accountability Act of 1997

                         (Sen. Jeffords (R) VT)

       The Administration applauds the Senate for its bipartisan 
     effort to improve S. 830 since it was reported by the Senate 
     Committee on Labor and Human Resources, and appreciates the 
     Senate's responsiveness to concerns that have been raised. 
     Because of the

[[Page S9850]]

     importance of obtaining a five-year extension of the 
     Prescription Drug User Fee Act (PDUFA), the Administration 
     has no objection to passage of the bill by the Senate at this 
     time. However, the Administration finds that the provisions 
     identified below are unacceptable and as the legislative 
     process continues, will work to ensure that our remaining 
     concerns are resolved.
       In general, this legislation represents a significant step 
     toward accomplishing our mutual goal of assuring the agency's 
     optimum performance while protecting the health of the 
     American public. The Administration, however, continues to 
     have two major concerns with the bill.
       First, section 404 of the bill would lower the review 
     standard for marketing approval by precluding the Food and 
     Drug Administration (FDA) from reviewing new medical devices 
     for uses other than those for which the manufacturer says 
     they are intended. Second, the PDUFA trigger as proposed in 
     S. 830 undercuts the bipartisan budget agreement (BBA) by 
     requiring budget increases for FDA not envisioned by the BBA, 
     and would interfere with HHS' ability to allocate resources 
     appropriately throughout the Department.
       In order to be able to support the final bill, the 
     Administration will continue to work with the House of 
     Representatives and in conference to resolve these and other 
     identified issues.

  Mr. JEFFORDS. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on the engrossment and third 
reading of the bill.
  The bill was ordered to be engrossed for a third reading, and was 
read the third time.
  The PRESIDING OFFICER. The bill having been read the third time, the 
question is, Shall it pass? On this question, the yeas and nays have 
been ordered, and the clerk will call the roll.
  The assistant legislative clerk called the roll.
  The PRESIDING OFFICER (Mr. Santorum). Are there any other Senators in 
the Chamber who desire to vote?
  The result was announced--yeas 98, nays 2, as follows:

                      [Rollcall Vote No. 256 Leg.]

                                YEAS--98

     Abraham
     Akaka
     Allard
     Ashcroft
     Baucus
     Bennett
     Biden
     Bingaman
     Bond
     Boxer
     Breaux
     Brownback
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Cleland
     Coats
     Cochran
     Collins
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Domenici
     Dorgan
     Durbin
     Enzi
     Faircloth
     Feingold
     Feinstein
     Ford
     Frist
     Glenn
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Harkin
     Hatch
     Helms
     Hollings
     Hutchinson
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnson
     Kempthorne
     Kerrey
     Kerry
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Moseley-Braun
     Moynihan
     Murkowski
     Murray
     Nickles
     Reid
     Robb
     Roberts
     Rockefeller
     Roth
     Santorum
     Sarbanes
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Torricelli
     Warner
     Wellstone
     Wyden

                                NAYS--2

     Kennedy
     Reed
       
  The bill (S. 830), as amended, was passed, as follows:

                                 S. 830

       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 
     Modernization and Accountability Act of 1997''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.

                   TITLE I--IMPROVING PATIENT ACCESS

Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expanded access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition 
              agreements and global harmonization efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.

          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.

           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
Sec. 405. Certainty of review timeframes.
Sec. 406. Limitations on initial classification determinations.
Sec. 407. Clarification with respect to a general use and specific use 
              of a device.
Sec. 408. Clarification of the number of required clinical 
              investigations for approval.
Sec. 409. Prohibited acts.

                   TITLE V--IMPROVING ACCOUNTABILITY

Sec. 501. Agency plan for statutory compliance and annual report.

     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket 
              notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.
Sec. 620. Disclosure.
Sec. 621. Referral statements relating to food nutrients.

                   TITLE VII--FEES RELATING TO DRUGS

Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.

                       TITLE VIII--MISCELLANEOUS

Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
              threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy 
              compounding.
Sec. 810. Reports of postmarketing approval studies.
Sec. 811. Information exchange.
Sec. 812. Reauthorization of clinical pharmacology program.
Sec. 813. Monograph for sunburn products.
Sec. 814. Safety report disclaimers.

     SEC. 3. REFERENCES.

       Except as otherwise expressly provided, wherever in this 
     Act an amendment or repeal is expressed in terms of an 
     amendment to, or repeal of, a section or other provision, the 
     reference shall be considered to be made to a section or 
     other provision of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321 et seq.).
                   TITLE I--IMPROVING PATIENT ACCESS

     SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

       Section 903 (21 U.S.C. 393) is amended--
       (1) by redesignating subsections (b) and (c) as subsections 
     (c) and (d), respectively; and
       (2) by inserting after subsection (a) the following:
       ``(b) Mission.--
       ``(1) In general.--The Secretary, acting through the 
     Commissioner, and in consultation, as determined appropriate 
     by the Secretary, with experts in science, medicine, and 
     public health, and in cooperation with consumers, users, 
     manufacturers, importers, packers, distributors, and 
     retailers of regulated products, shall protect the public 
     health by taking actions that help ensure that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;

[[Page S9851]]

       ``(B) human and veterinary drugs, including biologics, are 
     safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Secretary, acting through the 
     Commissioner, shall promptly and efficiently review clinical 
     research and take appropriate action on the marketing of 
     regulated products in a manner that does not unduly impede 
     innovation or product availability. The Secretary, acting 
     through the Commissioner, shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.

     SEC. 102. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

     ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
                   DIAGNOSTICS.

       ``(a) Emergency Situations.--The Secretary may, under 
     appropriate conditions determined by the Secretary, authorize 
     the shipment of investigational drugs (including 
     investigational biological products), or investigational 
     devices, (as defined in regulations prescribed by the 
     Secretary) for the diagnosis, monitoring, or treatment of a 
     serious disease or condition in emergency situations.
       ``(b) Individual Patient Access to Investigational Products 
     Intended for Serious Diseases.--Any person, acting through a 
     physician licensed in accordance with State law, may request 
     from a manufacturer or distributor, and any manufacturer or 
     distributor may provide to such physician after compliance 
     with the provisions of this subsection, an investigational 
     drug (including an investigational biological product), or 
     investigational device, (as defined in regulations prescribed 
     by the Secretary) for the diagnosis, monitoring, or treatment 
     of a serious disease or condition if--
       ``(1) the licensed physician determines that the person has 
     no comparable or satisfactory alternative therapy available 
     to diagnose, monitor, or treat the disease or condition 
     involved, and that the risk to the person from the 
     investigational drug or investigational device is not greater 
     than the risk from the disease or condition;
       ``(2) the Secretary determines that there is sufficient 
     evidence of safety and effectiveness to support the use of 
     the investigational drug or investigational device in the 
     case described in paragraph (1);
       ``(3) the Secretary determines that provision of the 
     investigational drug or investigational device will not 
     interfere with the initiation, conduct, or completion of 
     clinical investigations to support marketing approval; and
       ``(4) the product sponsor, or clinical investigator, of the 
     investigational drug or investigational device submits to the 
     Secretary a clinical protocol consistent with the provisions 
     of section 505(i) or 520(g) and any regulations promulgated 
     under section 505(i) or 520(g) describing the use of 
     investigational drugs or investigational devices in a single 
     patient or a small group of patients.
       ``(c) Treatment INDs/IDEs.--Upon submission by a product 
     sponsor or a physician of a protocol intended to provide 
     widespread access to an investigational product for eligible 
     patients, the Secretary shall permit an investigational drug 
     (including an investigational biological product) or 
     investigational device to be made available for expanded 
     access under a treatment investigational new drug application 
     or investigational device exemption (as the terms are 
     described in regulations prescribed by the Secretary) if the 
     Secretary determines that--
       ``(1) under the treatment investigational new drug 
     application or investigational device exemption, the 
     investigational drug or investigational device is intended 
     for use in the diagnosis, monitoring, or treatment of a 
     serious or immediately life-threatening disease or condition;
       ``(2) there is no comparable or satisfactory alternative 
     therapy available to diagnose, monitor, or treat that stage 
     of disease or condition in the population of patients to 
     which the investigational drug or investigational device is 
     intended to be administered;
       ``(3)(A) the investigational drug or investigational device 
     is under investigation in a controlled clinical trial for the 
     use described in paragraph (1) under an effective 
     investigational new drug application or investigational 
     device exemption; and
       ``(B) all clinical trials necessary for approval of that 
     use of the investigational drug or investigational device 
     have been completed;
       ``(4) the sponsor of the controlled clinical trials is 
     actively pursuing marketing approval of the investigational 
     drug or investigational device for the use described in 
     paragraph (1) with due diligence;
       ``(5) the provision of the investigational drug or 
     investigational device will not interfere with the enrollment 
     of patients in ongoing clinical investigations under section 
     505(i) or 520(g);
       ``(6) in the case of serious diseases, there is sufficient 
     evidence of safety and effectiveness to support the use 
     described in paragraph (1); and
       ``(7) in the case of immediately life-threatening diseases, 
     the available scientific evidence, taken as a whole, provides 
     a reasonable basis to conclude that the product may be 
     effective for its intended use and would not expose patients 
     to an unreasonable and significant risk of illness or injury.

     A protocol submitted under this subsection shall be subject 
     to the provisions of section 505(i) or 520(g) and regulations 
     promulgated under section 505(i) or 520(g). The Secretary may 
     inform national, State, and local medical associations and 
     societies, voluntary health associations, and other 
     appropriate persons about the availability of an 
     investigational drug or investigational device under expanded 
     access protocols submitted under this subsection. The 
     information provided by the Secretary, in accordance with the 
     preceding sentence, shall be of the same type of information 
     that is required by section 402(j)(3).

       ``(d) Termination.--The Secretary may, at any time, with 
     respect to a person, manufacturer, or distributor described 
     in this section, terminate expanded access provided under 
     this section for an investigational drug (including an 
     investigational biological product) or investigational device 
     if the requirements under this section are no longer met.''.

     SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.

       Section 520(m) (21 U.S.C. 360j(m)) is amended--
       (1) in paragraph (2), by adding at the end the following 
     flush sentences:

     ``The request shall be in the form of an application 
     submitted to the Secretary. Not later than 75 days after the 
     date of the receipt of the application, the Secretary shall 
     issue an order approving or denying the application.'';
       (2) in paragraph (4)--
       (A) in subparagraph (B), by inserting after ``(2)(A)'' the 
     following: ``, unless a physician determines that waiting for 
     such an approval from an institutional review committee will 
     cause harm or death to a patient, and makes a good faith 
     effort to obtain the approval, and does not receive a timely 
     response from an institutional review committee on the 
     request of the physician for approval to use the device for 
     such treatment or diagnosis''; and
       (B) by adding at the end the following flush sentences:

     ``In a case in which a physician described in subparagraph 
     (B) uses a device without an approval from an institutional 
     review committee, the physician shall, after the use of the 
     device, notify the chairperson of the institutional review 
     committee of such use. Such notification shall include the 
     identification of the patient involved, the date on which the 
     device was used, and the reason for the use.''; and
       (3) by striking paragraph (5) and inserting the following:
       ``(5) The Secretary may require a person granted an 
     exemption under paragraph (2) to demonstrate continued 
     compliance with the requirements of this subsection if the 
     Secretary believes such demonstration to be necessary to 
     protect the public health or if the Secretary has reason to 
     believe that the criteria for the exemption are no longer 
     met.''.
         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

     SEC. 201. INTERAGENCY COLLABORATION.

       Section 903(b) (21 U.S.C. 393(b)), as added by section 
     101(2), is amended by adding at the end the following:
       ``(3) Interagency collaboration.--The Secretary shall 
     implement programs and policies that will foster 
     collaboration between the Administration, the National 
     Institutes of Health, and other science-based Federal 
     agencies, to enhance the scientific and technical expertise 
     available to the Secretary in the conduct of the duties of 
     the Secretary with respect to the development, clinical 
     investigation, evaluation, and postmarket monitoring of 
     emerging medical therapies, including complementary 
     therapies, and advances in nutrition and food science.''.

     SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION 
                   AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.

       It is the sense of the Committee on Labor and Human 
     Resources of the Senate that--
       (1) the Secretary of Health and Human Services should 
     support the Office of the United States Trade Representative, 
     in consultation with the Secretary of Commerce, in efforts to 
     move toward the acceptance of mutual recognition agreements 
     relating to the regulation of drugs, biological products, 
     devices, foods, food additives, and color additives, and the 
     regulation of good manufacturing practices, between the 
     European Union and the United States;
       (2) the Secretary of Health and Human Services should 
     regularly participate in meetings with representatives of 
     other foreign governments to discuss and reach agreement on 
     methods and approaches to harmonize regulatory requirements; 
     and
       (3) the Office of International Relations of the Department 
     of Health and Human Services (as established under section 
     803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     383)) should have the responsibility of ensuring that the 
     process of harmonizing international regulatory requirements 
     is continuous.

     SEC. 203. CONTRACTS FOR EXPERT REVIEW.

       Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at 
     the end the following:

[[Page S9852]]

     ``SEC. 906. CONTRACTS FOR EXPERT REVIEW.

       ``(a) In General.--
       ``(1) Authority.--The Secretary may enter into a contract 
     with any organization or any individual (who is not an 
     employee of the Department) with expertise in a relevant 
     discipline, to review, evaluate, and make recommendations to 
     the Secretary on part or all of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for the approval or 
     classification of an article or made under section 351(a) of 
     the Public Health Service Act (42 U.S.C. 262(a)) with respect 
     to a biological product. Any such contract shall be subject 
     to the requirements of section 708 relating to the 
     confidentiality of information.
       ``(2) Increased efficiency and expertise through 
     contracts.--The Secretary shall use the authority granted in 
     paragraph (1) whenever the Secretary determines that a 
     contract described in paragraph (1) will improve the 
     timeliness or quality of the review of an application or 
     submission described in paragraph (1), unless using such 
     authority would reduce the quality, or unduly increase the 
     cost, of such review. Such improvement may include providing 
     the Secretary increased scientific or technical expertise 
     that is necessary to review or evaluate new therapies and 
     technologies.
       ``(b) Review of Expert Review.--
       ``(1) In general.--Subject to paragraph (2), the official 
     of the Food and Drug Administration responsible for any 
     matter for which expert review is used pursuant to subsection 
     (a) shall review the recommendations of the organization or 
     individual who conducted the expert review and shall make a 
     final decision regarding the matter within 60 days after 
     receiving the recommendations.
       ``(2) Limitation.--A final decision under paragraph (1) 
     shall be made within the applicable prescribed time period 
     for review of the matter as set forth in this Act or in the 
     Public Health Service Act (42 U.S.C. 201 et seq.).
       ``(3) Authority of secretary.--Notwithstanding subsection 
     (a), the Secretary shall retain full authority to make 
     determinations with respect to the approval or disapproval of 
     an article under this Act, the approval or disapproval of a 
     biologics license with respect to a biological product under 
     section 351(a) of the Public Health Service Act, or the 
     classification of an article as a device under section 
     513(f)(1).''.

     SEC. 204. ACCREDITED-PARTY REVIEWS.

       (a) In General.--Subchapter A of chapter V (21 U.S.C. 351 
     et seq.) is amended by adding at the end the following:

     ``SEC. 523. ACCREDITED-PARTY PARTICIPATION.

       ``(a) Accreditation.--Not later than 1 year after the date 
     of enactment of this section, the Secretary shall accredit 
     entities or individuals who are not employees of the Federal 
     Government to review reports made to the Secretary under 
     section 510(k) for devices and make recommendations to the 
     Secretary regarding the initial classification of such 
     devices under section 513(f)(1), except that this paragraph 
     shall not apply to a report made to the Secretary under 
     section 510(k) for a device that is--
       ``(1) for a use in supporting or sustaining human life;
       ``(2) for implantation in the human body for more than 1 
     year; or
       ``(3) for a use that is of substantial importance in 
     preventing the impairment of human health.
       ``(b) Accreditation.--Within 180 days after the date of 
     enactment of this section, the Secretary shall adopt methods 
     of accreditation that ensure that entities or individuals who 
     conduct reviews and make recommendations under this section 
     are qualified, properly trained, knowledgeable about handling 
     confidential documents and information, and free of conflicts 
     of interest. The Secretary shall publish the methods of 
     accreditation in the Federal Register on the adoption of the 
     methods.
       ``(c) Withdrawal of Accreditation.--The Secretary may 
     suspend or withdraw the accreditation of any entity or 
     individual accredited under this section, after providing 
     notice and an opportunity for an informal hearing, if such 
     entity or individual acts in a manner that is substantially 
     not in compliance with the requirements established by the 
     Secretary under subsection (b), including the failure to 
     avoid conflicts of interest, the failure to protect 
     confidentiality of information, or the failure to competently 
     review premarket submissions for devices.
       ``(d) Selection and Compensation.--A person who intends to 
     make a report described in subsection (a) to the Secretary 
     shall have the option to select an accredited entity or 
     individual to review such report. Upon the request by a 
     person to have a report reviewed by an accredited entity or 
     individual, the Secretary shall identify for the person no 
     less than 2 accredited entities or individuals from whom the 
     selection may be made. Compensation for an accredited entity 
     or individual shall be determined by agreement between the 
     accredited entity or individual and the person who engages 
     the services of the accredited entity or individual and shall 
     be paid by the person who engages such services.
       ``(e) Review by Secretary.--
       ``(1) In general.--The Secretary shall require an 
     accredited entity or individual, upon making a recommendation 
     under this section with respect to an initial classification 
     of a device, to notify the Secretary in writing of the 
     reasons for such recommendation.
       ``(2) Time period for review.--Not later than 30 days after 
     the date on which the Secretary is notified under paragraph 
     (1) by an accredited entity or individual with respect to a 
     recommendation of an initial classification of a device, the 
     Secretary shall make a determination with respect to the 
     initial classification.
       ``(3) Special rule.--The Secretary may change the initial 
     classification under section 513(f)(1) that is recommended by 
     the accredited entity or individual under this section, and 
     in such case shall notify in writing the person making the 
     report described in subsection (a) of the detailed reasons 
     for the change.
       ``(f) Duration.--The authority provided by this section 
     terminates--
       ``(1) 5 years after the date on which the Secretary 
     notifies Congress that at least 2 persons accredited under 
     subsection (b) are available to review at least 60 percent of 
     the submissions under section 510(k); or
       ``(2) 4 years after the date on which the Secretary 
     notifies Congress that at least 35 percent of the devices 
     that are subject to review under subsection (a), and that 
     were the subject of final action by the Secretary in the 
     fiscal year preceding the date of such notification, were 
     reviewed by the Secretary under subsection (e),
     whichever occurs first.
       ``(g) Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall contract with 
     an independent research organization to prepare and submit to 
     the Secretary a written report examining the use of 
     accredited entities and individuals to conduct reviews under 
     this section. The Secretary shall submit the report to 
     Congress not later than 6 months prior to the conclusion of 
     the applicable period described in subsection (f).
       ``(2) Contents.--The report by the independent research 
     organization described in paragraph (1) shall identify the 
     benefits or detriments to public and patient health of using 
     accredited entities and individuals to conduct such reviews, 
     and shall summarize all relevant data, including data on the 
     review of accredited entities and individuals (including data 
     on the review times, recommendations, and compensation of the 
     entities and individuals), and data on the review of the 
     Secretary (including data on the review times, changes, and 
     reasons for changes of the Secretary).''.
       (b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended 
     by adding at the end the following:
       ``(f)(1) A person accredited under section 523 to review 
     reports made under section 510(k) and make recommendations of 
     initial classifications of devices to the Secretary shall 
     maintain records documenting the training qualifications of 
     the person and the employees of the person, the procedures 
     used by the person for handling confidential information, the 
     compensation arrangements made by the person in accordance 
     with section 523(d), and the procedures used by the person to 
     identify and avoid conflicts of interest. Upon the request of 
     an officer or employee designated by the Secretary, the 
     person shall permit the officer or employee, at all 
     reasonable times, to have access to, to copy, and to verify, 
     the records.
       ``(2) Within 15 days after the receipt of a written request 
     from the Secretary to a person accredited under section 523 
     for copies of records described in paragraph (1), the person 
     shall produce the copies of the records at the place 
     designated by the Secretary.''.

     SEC. 205. DEVICE PERFORMANCE STANDARDS.

       (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is 
     amended by adding at the end the following:

                      ``Recognition of a Standard

       ``(c)(1)(A) In addition to establishing performance 
     standards under this section, the Secretary may, by 
     publication in the Federal Register, recognize all or part of 
     a performance standard established by a nationally or 
     internationally recognized standard development organization 
     for which a person may submit a declaration of conformity in 
     order to meet premarket submission requirements or other 
     requirements under this Act to which such standards are 
     applicable.
       ``(B) If a person elects to use a performance standard 
     recognized by the Secretary under subparagraph (A) to meet 
     the requirements described in subparagraph (A), the person 
     shall provide a declaration of conformity to the Secretary 
     that certifies that the device is in conformity with such 
     standard. A person may elect to use data, or information, 
     other than data required by a standard recognized under 
     subparagraph (A) to fulfill or satisfy any requirement under 
     this Act.
       ``(2) The Secretary may withdraw such recognition of a 
     performance standard through publication of a notice in the 
     Federal Register that the Secretary will no longer recognize 
     the standard, if the Secretary determines that the standard 
     is no longer appropriate for meeting the requirements under 
     this Act.
       ``(3)(A) Subject to subparagraph (B), the Secretary shall 
     accept a declaration of conformity that a device is in 
     conformity with a standard recognized under paragraph (1) 
     unless the Secretary finds--
       ``(i) that the data or information submitted to support 
     such declaration does not demonstrate that the device is in 
     conformity with the standard identified in the declaration of 
     conformity; or
       ``(ii) that the standard identified in the declaration of 
     conformity is not applicable to the particular device under 
     review.

[[Page S9853]]

       ``(B) The Secretary may request, at any time, the data or 
     information relied on by the person to make a declaration of 
     conformity with respect to a standard recognized under 
     paragraph (1).
       ``(C) A person relying on a declaration of conformity with 
     respect to a standard recognized under paragraph (1) shall 
     maintain the data and information demonstrating conformity of 
     the device to the standard for a period of 2 years after the 
     date of the classification or approval of the device by the 
     Secretary or a period equal to the expected design life of 
     the device, whichever is longer.''.
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by 
     adding at the end the following:
       ``(x) The falsification of a declaration of conformity 
     submitted under subsection (c) of section 514 or the failure 
     or refusal to provide data or information requested by the 
     Secretary under section 514(c)(3).''.
       (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is 
     amended--
       (1) by striking ``(e)'' and inserting ``(e)(1)''; and
       (2) by inserting at the end the following:
       ``(2) If it is declared to be, purports to be, or is 
     represented as, a device that is in conformity with any 
     performance standard recognized under section 514(c) unless 
     such device is in all respects in conformity with such 
     standard.''.
          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

     SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA 
                   REQUIREMENTS.

       Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by 
     adding at the end the following:
       ``(C)(i)(I) The Secretary, upon the written request of any 
     person intending to submit an application under section 515, 
     shall meet with such person to determine the type of valid 
     scientific evidence (within the meaning of subparagraphs (A) 
     and (B)) that will be necessary to demonstrate the 
     effectiveness of a device for the conditions of use proposed 
     by such person, to support an approval of an application. The 
     written request shall include a detailed description of the 
     device, a detailed description of the proposed conditions of 
     use of the device, a proposed plan for determining whether 
     there is a reasonable assurance of effectiveness, and, if 
     available, information regarding the expected performance 
     from the device. Within 30 days after such meeting, the 
     Secretary shall specify in writing the type of valid 
     scientific evidence that will provide a reasonable assurance 
     that a device is effective under the conditions of use 
     proposed by such person.
       ``(II) Any clinical data, including 1 or more well-
     controlled investigations, specified in writing by the 
     Secretary for demonstrating a reasonable assurance of device 
     effectiveness shall be specified as a result of a 
     determination by the Secretary--
       ``(aa) that such data are necessary to establish device 
     effectiveness; and
       ``(bb) that no other less burdensome means of evaluating 
     device effectiveness is available that would have a 
     reasonable likelihood of resulting in an approval.
       ``(ii) The determination of the Secretary with respect to 
     the specification of valid scientific evidence under clause 
     (i) shall be binding upon the Secretary, unless such 
     determination by the Secretary could be contrary to the 
     public health.''.

     SEC. 302. COLLABORATIVE REVIEW PROCESS.

       Section 515(d) (21 U.S.C. 360e(d)) is amended--
       (1) in paragraph (1)(A), by striking ``paragraph (2) of 
     this subsection'' each place it appears and inserting 
     ``paragraph (4)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (4) and (5), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A)(i) The Secretary shall, upon the written request 
     of an applicant, meet with the applicant, not later than 100 
     days after the receipt of an application from the applicant 
     that has been filed as complete under subsection (c), to 
     discuss the review status of the application.
       ``(ii) If the application does not appear in a form that 
     would require an approval under this subsection, the 
     Secretary shall in writing, and prior to the meeting, provide 
     to the applicant a description of any deficiencies in the 
     application identified by the Secretary based on an interim 
     review of the entire application and identify the information 
     that is required to correct those deficiencies.
       ``(iii) The Secretary and the applicant may, by mutual 
     consent, establish a different schedule for a meeting 
     required under this paragraph.
       ``(B) The Secretary shall notify the applicant immediately 
     of any deficiency identified in the application that was not 
     described as a deficiency in the written description provided 
     by the Secretary under subparagraph (A).''.
           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

     SEC. 401. POLICY STATEMENTS.

       Section 701(a) (21 U.S.C. 371(a)) is amended--
       (1) by striking ``(a) The'' and inserting ``(a)(1) The''; 
     and
       (2) by adding at the end the following:
       ``(2) Not later than February 27, 1999, the Secretary, 
     after evaluating the effectiveness of the Good Guidance 
     Practices document published in the Federal Register at 62 
     Fed. Reg. 8961, shall promulgate a regulation specifying the 
     policies and procedures of the Food and Drug Administration 
     for the development, issuance, and use of guidance 
     documents.''.

     SEC. 402. PRODUCT CLASSIFICATION.

       Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at 
     the end the following:

  ``Subchapter D--Classification of Products and Environmental Impact 
                                Reviews

     ``SEC. 741. CLASSIFICATION OF PRODUCTS.

       ``(a) Request.--A person who submits an application or 
     submission (including a petition, notification, and any other 
     similar form of request) under this Act, may submit a request 
     to the Secretary respecting the classification of an article 
     as a drug, biological product, device, or a combination 
     product subject to section 503(g) or respecting the component 
     of the Food and Drug Administration that will regulate the 
     article. In submitting the request, the person shall 
     recommend a classification for the article, or a component to 
     regulate the article, as appropriate.
       ``(b) Statement.--Not later than 60 days after the receipt 
     of the request described in subsection (a), the Secretary 
     shall determine the classification of the article or the 
     component of the Food and Drug Administration that will 
     regulate the article and shall provide to the person a 
     written statement that identifies the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and the reasons for such 
     determination. The Secretary may not modify such statement 
     except with the written consent of the person or for public 
     health reasons.
       ``(c) Inaction of Secretary.--If the Secretary does not 
     provide the statement within the 60-day period described in 
     subsection (b), the recommendation made by the person under 
     subsection (a) shall be considered to be a final 
     determination by the Secretary of the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and may not be modified by the 
     Secretary except with the written consent of the person or 
     for public health reasons.''.

     SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.

       (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) 
     is amended to read as follows:
       ``(4)(A) Any information contained in an application for 
     premarket approval filed with the Secretary pursuant to 
     section 515(c) (including information from clinical and 
     preclinical tests or studies that demonstrate the safety and 
     effectiveness of a device, but excluding descriptions of 
     methods of manufacture and product composition) shall be 
     available, 6 years after the application has been approved by 
     the Secretary, for use by the Secretary in--
       ``(i) approving another device;
       ``(ii) determining whether a product development protocol 
     has been completed, under section 515 for another device;
       ``(iii) establishing a performance standard or special 
     control under this Act; or
       ``(iv) classifying or reclassifying another device under 
     section 513 and subsection (l)(2).
       ``(B) The publicly available detailed summaries of 
     information respecting the safety and effectiveness of 
     devices required by paragraph (1)(A) shall be available for 
     use by the Secretary as the evidentiary basis for the agency 
     actions described in subparagraph (A).''.
       (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 
     360g(a)) is amended--
       (1) in paragraph (8), by adding ``or'' at the end;
       (2) in paragraph (9), by striking ``, or'' and inserting a 
     comma; and
       (3) by striking paragraph (10).

     SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT 
                   REVIEW.

       (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 
     360e(d)(1)(A)) is amended by adding at the end the following 
     flush sentences:
     ``In making the determination whether to approve or deny the 
     application, the Secretary shall rely on the conditions of 
     use included in the proposed labeling as the basis for 
     determining whether or not there is a reasonable assurance of 
     safety and effectiveness, if the proposed labeling is neither 
     false nor misleading. In determining whether or not such 
     labeling is false or misleading, the Secretary shall fairly 
     evaluate all material facts pertinent to the proposed 
     labeling.''.
       (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) Whenever the Secretary requests information to 
     demonstrate that the devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to make a 
     substantial equivalence determination. In making such a 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and shall 
     request information accordingly.
       ``(D) The determination of the Secretary under this 
     subsection and section 513(f)(1) with respect to the intended 
     use of a device shall be based on the intended use included 
     in the proposed labeling of the device submitted in a report 
     under section 510(k).''.
       (c) Rule of Construction.--Nothing in the amendments made 
     by subsections (a) and (b) shall be construed to alter any 
     authority of the Secretary of Health and Human Services to 
     regulate any tobacco product, or any additive or ingredient 
     of a tobacco product.

[[Page S9854]]

     SEC. 405. CERTAINTY OF REVIEW TIMEFRAMES.

       (a) Clarification on the 90-Day Timeframe for Premarket 
     Notification Reviews.--Section 510(k) (21 U.S.C. 360) is 
     amended by adding at the end the following flush sentence:

     ``The Secretary shall review the report required by this 
     subsection and make a determination under section 513(f)(1) 
     not later than 90 days after receiving the report.''.
       (b) One-Cycle Review.--Section 515(d) (21 U.S.C. 360e(d)), 
     as amended by section 302, is amended by inserting after 
     paragraph (2) the following:
       ``(3) Except as provided in paragraph (1), the period for 
     the review of an application by the Secretary under this 
     subsection shall be not more than 180 days. Such period may 
     not be restarted or extended even if the application is 
     amended. The Secretary is not required to review a major 
     amendment to an application, unless the amendment is made in 
     response to a request by the Secretary for information.''.

     SEC. 406. LIMITATIONS ON INITIAL CLASSIFICATION 
                   DETERMINATIONS.

       Section 510 (21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(m) The Secretary may not withhold a determination of the 
     initial classification of a device under section 513(f)(1) 
     because of a failure to comply with any provision of this Act 
     that is unrelated to a substantial equivalence decision, 
     including a failure to comply with the requirements relating 
     to good manufacturing practices under section 520(f).''.

     SEC. 407. CLARIFICATION WITH RESPECT TO A GENERAL USE AND 
                   SPECIFIC USE OF A DEVICE.

       Not later than 270 days after the date of enactment of this 
     section, the Secretary of Health and Human Services shall 
     promulgate a final regulation specifying the general 
     principles that the Secretary of Health and Human Services 
     will consider in determining when a specific intended use of 
     a device is not reasonably included within a general use of 
     such device for purposes of a determination of substantial 
     equivalence under section 513(f)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).

     SEC. 408. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
                   INVESTIGATIONS FOR APPROVAL.

       (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 
     360c(a)(3)(A)) is amended by striking ``clinical 
     investigations'' and inserting ``1 or more clinical 
     investigations''.
       (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is 
     amended by adding at the end the following: ``Substantial 
     evidence may, as appropriate, consist of data from 1 adequate 
     and well-controlled clinical investigation and confirmatory 
     evidence (obtained prior to or after such investigation), if 
     the Secretary determines, based on relevant science, that 
     such data and evidence are sufficient to establish 
     effectiveness.''.

     SEC. 409. PROHIBITED ACTS.

       Section 301(l) (21 U.S.C. 331(l)) is repealed.
                   TITLE V--IMPROVING ACCOUNTABILITY

     SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL 
                   REPORT.

       Section 903(b) (21 U.S.C. 393(b)), as amended by section 
     201, is further amended by adding at the end the following:
       ``(4) Agency plan for statutory compliance.--
       ``(A) In general.--Not later than 180 days after the date 
     of enactment of this paragraph, the Secretary, after 
     consultation with relevant experts, health care 
     professionals, representatives of patient and consumer 
     advocacy groups, and the regulated industry, shall develop 
     and publish in the Federal Register a plan bringing the 
     Secretary into compliance with each of the obligations of the 
     Secretary under this Act and other relevant statutes. The 
     Secretary shall biannually review the plan and shall revise 
     the plan as necessary, in consultation with such persons.
       ``(B) Objectives of agency plan.--The plan required by 
     subparagraph (A) shall establish objectives, and mechanisms 
     to be used by the Secretary, acting through the Commissioner, 
     including objectives and mechanisms that--
       ``(i) minimize deaths of, and harm to, persons who use or 
     may use an article regulated under this Act;
       ``(ii) maximize the clarity of, and the availability of 
     information about, the process for review of applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act, 
     including information for potential consumers and patients 
     concerning new products;
       ``(iii) implement all inspection and postmarket monitoring 
     provisions of this Act by July 1, 1999;
       ``(iv) ensure access to the scientific and technical 
     expertise necessary to ensure compliance by the Secretary 
     with the statutory obligations described in subparagraph (A);
       ``(v) establish a schedule to bring the Administration into 
     full compliance by July 1, 1999, with the time periods 
     specified in this Act for the review of all applications and 
     submissions described in clause (ii) and submitted after the 
     date of enactment of this paragraph; and
       ``(vi) reduce backlogs in the review of all applications 
     and submissions described in clause (ii) for any article with 
     the objective of eliminating all backlogs in the review of 
     the applications and submissions by January 1, 2000.
       ``(5) Annual report.--
       ``(A) Contents.--The Secretary shall prepare and publish in 
     the Federal Register and solicit public comment on an annual 
     report that--
       ``(i) provides detailed statistical information on the 
     performance of the Secretary under the plan described in 
     paragraph (4);
       ``(ii) compares such performance of the Secretary with the 
     objectives of the plan and with the statutory obligations of 
     the Secretary;
       ``(iii) analyzes any failure of the Secretary to achieve 
     any objective of the plan or to meet any statutory 
     obligation;
       ``(iv) identifies any regulatory policy that has a 
     significant impact on compliance with any objective of the 
     plan or any statutory obligation; and
       ``(v) sets forth any proposed revision to any such 
     regulatory policy, or objective of the plan that has not been 
     met.
       ``(B) Statistical information.--The statistical information 
     described in subparagraph (A)(i) shall include a full 
     statistical presentation relating to all applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act and 
     approved or subject to final action by the Secretary during 
     the year covered by the report. In preparing the statistical 
     presentation, the Secretary shall take into account the date 
     of--
       ``(i) the submission of any investigational application;
       ``(ii) the application of any clinical hold;
       ``(iii) the submission of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for approval or 
     clearance;
       ``(iv) the acceptance for filing of any application or 
     submission described in clause (iii) for approval or 
     clearance;
       ``(v) the occurrence of any unapprovable action;
       ``(vi) the occurrence of any approvable action; and
       ``(vii) the approval or clearance of any application or 
     submission described in clause (iii).
       ``(C) Special rule.--If the Secretary provides information 
     in a report required by section 705 of the Food and Drug 
     Administration Modernization and Accountability Act of 1997 
     or a report required by the amendments made by the Government 
     Performance and Results Act of 1993 and that information is 
     required by this paragraph, the report shall be deemed to 
     satisfy the requirements of this paragraph relating to that 
     information.''.
     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

     SEC. 601. MINOR MODIFICATIONS.

       (a) Action on Investigational Device Exemptions.--Section 
     520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
     the following:
       ``(6)(A) The Secretary shall, not later than 120 days after 
     the date of enactment of this paragraph, by regulation modify 
     parts 812 and 813 of title 21, Code of Federal Regulations to 
     update the procedures and conditions under which a device 
     intended for human use may, upon application by the sponsor 
     of the device, be granted an exemption from the requirements 
     of this Act.
       ``(B) The regulation shall permit developmental changes in 
     a device (including manufacturing changes) in response to 
     information collected during an investigation without 
     requiring an additional approval of an application for an 
     investigational device exemption or the approval of a 
     supplement to such application, if the sponsor of the 
     investigation determines, based on credible information, 
     prior to making any such changes, that the changes--
       ``(i) do not affect the scientific soundness of an 
     investigational plan submitted under paragraph (3)(A) or the 
     rights, safety, or welfare of the human subjects involved in 
     the investigation; and
       ``(ii) do not constitute a significant change in design, or 
     a significant change in basic principles of operation, of the 
     device.''.
       (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 
     360e(d)(1)(B)) is amended by adding at the end the following:
       ``(iii) The Secretary shall accept and review data and any 
     other information from investigations conducted under the 
     authority of regulations required by section 520(g), to make 
     a determination of whether there is a reasonable assurance of 
     safety and effectiveness of a device subject to a pending 
     application under this section if--
       ``(I) the data or information is derived from 
     investigations of an earlier version of the device, the 
     device has been modified during or after the investigations 
     (but prior to submission of an application under subsection 
     (c)) and such a modification of the device does not 
     constitute a significant change in the design or in the basic 
     principles of operation of the device that would invalidate 
     the data or information; or
       ``(II) the data or information relates to a device approved 
     under this section, is available for use under this Act, and 
     is relevant to the design and intended use of the device for 
     which the application is pending.''.
       (c) Action on Supplements.--Section 515(d) (21 U.S.C. 
     360e(d)), as amended by section 302, is further amended by 
     adding at the end the following:
       ``(6)(A)(i) A supplemental application shall be required 
     for any change to a device subject to an approved application 
     under this subsection that affects safety or effectiveness, 
     unless such change is a modification in a manufacturing 
     procedure or method of

[[Page S9855]]

     manufacturing and the holder of the approved application 
     submits a written notice to the Secretary that describes in 
     detail the change, summarizes the data or information 
     supporting the change, and informs the Secretary that the 
     change has been made under the requirements of section 
     520(f).
       ``(ii) The holder of an approved application who submits a 
     notice under clause (i) with respect to a manufacturing 
     change of a device may distribute the device 30 days after 
     the date on which the Secretary receives the notice, unless 
     the Secretary within such 30-day period notifies the holder 
     that the notice is not adequate and describes such further 
     information or action that is required for acceptance of such 
     change. If the Secretary notifies the holder that a premarket 
     approval supplement is required, the Secretary shall review 
     the supplement within 135 days after the receipt of the 
     supplement. The time used by the Secretary to review the 
     notice of the manufacturing change shall be deducted from the 
     135-day review period if the notice meets appropriate content 
     requirements for premarket approval supplements.
       ``(B)(i) Subject to clause (ii), in reviewing a supplement 
     to an approved application, for an incremental change to the 
     design of a device that affects safety or effectiveness, the 
     Secretary shall approve such supplement if--
       ``(I) nonclinical data demonstrate that the design 
     modification creates the intended additional capacity, 
     function, or performance of the device; and
       ``(II) clinical data from the approved application and any 
     supplement to the approved application provide a reasonable 
     assurance of safety and effectiveness for the changed device.
       ``(ii) The Secretary may require, when necessary, 
     additional clinical data to evaluate the design modification 
     of the device to provide a reasonable assurance of safety and 
     effectiveness.''.

     SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     402, is further amended by adding at the end the following:

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

       ``Notwithstanding any other provision of law, an 
     environmental impact statement prepared in accordance with 
     the regulations published in part 25 of title 21, Code of 
     Federal Regulations (as in effect on August 31, 1997) in 
     connection with an action carried out under (or a 
     recommendation or report relating to) this Act, shall be 
     considered to meet the requirements for a detailed statement 
     under section 102(2)(C) of the National Environmental Policy 
     Act of 1969 (42 U.S.C. 4332(2)(C)).''.

     SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM 
                   PREMARKET NOTIFICATION REQUIREMENT.

       (a) Class I and Class II Devices.--Section 510(k) (21 
     U.S.C. 360(k)) is amended by striking ``intended for human 
     use'' and inserting ``intended for human use (except a device 
     that is classified into class I under section 513 or 520 
     unless the Secretary determines such device is intended for a 
     use that is of substantial importance in preventing 
     impairment of human health or such device presents a 
     potential unreasonable risk of illness or injury, or a device 
     that is classified into class II under section 513 or 520 and 
     is exempt from the requirements of this subsection under 
     subsection (l))''.
       (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) 
     is amended by inserting after subsection (k) the following:
       ``(l)(1) Not later than 30 days after the date of enactment 
     of this subsection, the Secretary shall publish in the 
     Federal Register a list of each type of class II device that 
     does not require a notification under subsection (k) to 
     provide reasonable assurance of safety and effectiveness. 
     Each type of class II device identified by the Secretary not 
     to require the notification shall be exempt from the 
     requirement to provide notification under subsection (k) as 
     of the date of the publication of the list in the Federal 
     Register.
       ``(2) Beginning on the date that is 1 day after the date of 
     the publication of a list under this subsection, the 
     Secretary may exempt a class II device from the notification 
     requirement of subsection (k), upon the Secretary's own 
     initiative or a petition of an interested person, if the 
     Secretary determines that such notification is not necessary 
     to assure the safety and effectiveness of the device. The 
     Secretary shall publish in the Federal Register notice of the 
     intent of the Secretary to exempt the device, or of the 
     petition, and provide a 30-day period for public comment. 
     Within 120 days after the issuance of the notice in the 
     Federal Register, the Secretary shall publish an order in the 
     Federal Register that sets forth the final determination of 
     the Secretary regarding the exemption of the device that was 
     the subject of the notice.''.

     SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

       Section 513(f) (21 U.S.C. 360c(f)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (B), by striking ``paragraph (2)'' and 
     inserting ``paragraph (3)''; and
       (B) in the last sentence, by striking ``paragraph (2)'' and 
     inserting ``paragraph (2) or (3)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A) Any person who submits a report under section 
     510(k) for a type of device that has not been previously 
     classified under this Act, and that is classified into class 
     III under paragraph (1), may request, within 30 days after 
     receiving written notice of such a classification, the 
     Secretary to classify the device under the criteria set forth 
     in subparagraphs (A) through (C) subsection (a)(1). The 
     person may, in the request, recommend to the Secretary a 
     classification for the device. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.
       ``(B)(i) Not later than 60 days after the date of the 
     submission of the request under subparagraph (A) for 
     classification of a device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1), the 
     Secretary shall by written order classify the device. Such 
     classification shall be the initial classification of the 
     device for purposes of paragraph (1) and any device 
     classified under this paragraph shall be a predicate device 
     for determining substantial equivalence under paragraph (1).
       ``(ii) A device that remains in class III under this 
     subparagraph shall be deemed to be adulterated within the 
     meaning of section 501(f)(1)(B) until approved under section 
     515 or exempted from such approval under section 520(g).
       ``(C) Within 30 days after the issuance of an order 
     classifying a device under this paragraph, the Secretary 
     shall publish a notice in the Federal Register announcing 
     such classification.''.

     SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.

       (a) Release of Information.--Section 519(e) (21 U.S.C. 
     360i(e)) is amended by adding at the end the following flush 
     sentence:
     ``Any patient receiving a device subject to tracking under 
     this section may refuse to release, or refuse permission to 
     release, the patient's name, address, social security number, 
     or other identifying information for the purpose of 
     tracking.''.
       (b) Publication of Certain Devices.--Not later than 180 
     days after the date of enactment of this Act, the Secretary 
     of Health and Human Services shall develop and publish in the 
     Federal Register a list that identifies each type of device 
     subject to tracking under section 519(e)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each 
     device not identified by the Secretary of Health and Human 
     Services under this subsection or designated by the Secretary 
     under section 519(e)(2) shall be deemed to be exempt from the 
     mandatory tracking requirement under section 519 of such Act. 
     The Secretary of Health and Human Services shall have 
     authority to modify the list of devices exempted from the 
     mandatory tracking requirements.

     SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET 
                   SURVEILLANCE.

       (a) In General.--Section 522 (21 U.S.C. 360l) is amended by 
     striking ``Sec. 522.'' and all that follows through ``(2) 
     Discretionary surveillance.--The'' and inserting the 
     following:
       ``Sec. 522. (a) Discretionary Surveillance.--The''.
       (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 
     360l(b)) is amended to read as follows:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each manufacturer that receives notice 
     from the Secretary that the manufacturer is required to 
     conduct surveillance of a device under subsection (a) shall, 
     not later than 30 days after receiving the notice, submit for 
     the approval of the Secretary, a plan for the required 
     surveillance.
       ``(2) Determination.--Not later than 60 days after the 
     receipt of the plan, the Secretary shall determine if a 
     person proposed in the plan to conduct the surveillance has 
     sufficient qualifications and experience to conduct the 
     surveillance and if the plan will result in the collection of 
     useful data that can reveal unforeseen adverse events or 
     other information necessary to protect the public health and 
     to provide safety and effectiveness information for the 
     device.
       ``(3) Limitation on plan approval.--The Secretary may not 
     approve the plan until the plan has been reviewed by a 
     qualified scientific and technical review committee 
     established by the Secretary.''.

     SEC. 607. REPORTING.

       (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
       (1) in subsection (a)--
       (A) in the first sentence by striking ``make such reports, 
     and provide such information,'' and inserting ``and each such 
     manufacturer or importer shall make such reports, provide 
     such information, and submit such samples and components of 
     devices (as required by paragraph (10)),'';
       (B) in paragraph (8), by striking ``; and'' and inserting a 
     semicolon; and
       (C) by striking paragraph (9) and inserting the following:
       ``(9) shall require distributors to keep records and make 
     such records available to the Secretary upon request; and'';
       (2) by striking subsection (d); and
       (3) in subsection (f), by striking ``, importer, or 
     distributor'' each place it appears and inserting ``or 
     importer''.
       (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is 
     amended--
       (1) by redesignating paragraph (4) as paragraph (5);
       (2) by inserting after paragraph (3), the following:
       ``(4) any distributor who acts as a wholesale distributor 
     of devices, and who does not

[[Page S9856]]

     manufacture, repackage, process, or relabel a device; or''; 
     and
       (3) by adding at the end the following flush sentence:

     ``In this subsection, the term `wholesale distributor' means 
     any person who distributes a device from the original place 
     of manufacture to the person who makes the final delivery or 
     sale of the device to the ultimate consumer or user.''.

     SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.

       (a) New Drugs.--Section 505(c) (21 U.S.C. 355(c)) is 
     amended by adding at the end the following:
       ``(4) A new drug manufactured in a pilot or other small 
     facility may be used to demonstrate the safety 
     and effectiveness of the new drug and to obtain approval 
     of the new drug prior to scaling up to a larger facility, 
     unless the Secretary determines that a full scale 
     production facility is necessary to ensure the safety or 
     effectiveness of the new drug.''.
       (b) New Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) 
     is amended by adding at the end the following:
       ``(4) A new animal drug manufactured in a pilot or other 
     small facility may be used to demonstrate the safety and 
     effectiveness of the new drug and to obtain approval of the 
     new drug prior to scaling up to a larger facility, unless the 
     Secretary determines that a full scale production facility is 
     necessary to ensure the safety or effectiveness of the new 
     drug.''.

     SEC. 609. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

       (a) Requirements.--
       (1) Regulations.--
       (A) Proposed regulations.--Not later than 180 days after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services, after consultation with patient advocacy 
     groups, associations, physicians licensed to use 
     radiopharmaceuticals, and the regulated industry, shall issue 
     proposed regulations governing the approval of 
     radiopharmaceuticals designed for diagnosis and monitoring of 
     diseases and conditions. The regulations shall provide that 
     the determination of the safety and effectiveness of such a 
     radiopharmaceutical under section 505 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the 
     Public Health Service Act (42 U.S.C. 262) shall include (but 
     not be limited to) consideration of the proposed use of the 
     radiopharmaceutical in the practice of medicine, the 
     pharmacological and toxicological activity of the 
     radiopharmaceutical (including any carrier or ligand 
     component of the radiopharmaceutical), and the estimated 
     absorbed radiation dose of the radiopharmaceutical.
       (B) Final regulations.--Not later than 18 months after the 
     date of enactment of this Act, the Secretary shall promulgate 
     final regulations governing the approval of the 
     radiopharmaceuticals.
       (2) Special rule.--In the case of a radiopharmaceutical 
     intended to be used for diagnostic or monitoring purposes, 
     the indications for which such radiopharmaceutical is 
     approved for marketing may, in appropriate cases, refer to 
     manifestations of disease (such as biochemical, 
     physiological, anatomic, or pathological processes) common 
     to, or present in, 1 or more disease states.
       (b) Definition.--In this section, the term 
     ``radiopharmaceutical'' means--
       (1) an article--
       (A) that is intended for use in the diagnosis or monitoring 
     of a disease or a manifestation of a disease in humans; and
       (B) that exhibits spontaneous disintegration of unstable 
     nuclei with the emission of nuclear particles or photons; or
       (2) any nonradioactive reagent kit or nuclide generator 
     that is intended to be used in the preparation of any such 
     article.

     SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

       (a) Licenses.--
       (1) In general.--Section 351(a) of the Public Health 
     Service (42 U.S.C. 262(a)) is amended to read as follows:
       ``(a)(1) Except as provided in paragraph (4), no person 
     shall introduce or deliver for introduction into interstate 
     commerce any biological product unless--
       ``(A) a biologics license is in effect for the biological 
     product; and
       ``(B) each package of the biological product is plainly 
     marked with--
       ``(i) the proper name of the biological product contained 
     in the package;
       ``(ii) the name, address, and applicable license number of 
     the manufacturer of the biological product; and
       ``(iii) the expiration date of the biological product.
       ``(2)(A) The Secretary shall establish, by regulation, 
     requirements for the approval, suspension, and revocation of 
     biologics licenses.
       ``(B) The Secretary shall approve a biologics license 
     application on the basis of a demonstration that--
       ``(i) the biological product that is the subject of the 
     application is safe, pure, and potent; and
       ``(ii) the facility in which the biological product is 
     manufactured, processed, packed, or held meets standards 
     designed to assure that the biological product continues to 
     be safe, pure, and potent.
       ``(3) A biologics license application shall be approved 
     only if the applicant (or other appropriate person) consents 
     to the inspection of the facility that is the subject of the 
     application, in accordance with subsection (c).
       ``(4) The Secretary shall prescribe requirements under 
     which a biological product undergoing investigation shall be 
     exempt from the requirements of paragraph (1).''.
       (2) Elimination of existing license requirement.--Section 
     351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
     amended--
       (A) by striking ``(d)(1)'' and all that follows through 
     ``of this section.'';
       (B) in paragraph (2)--
       (i) by striking ``(2)(A) Upon'' and inserting ``(d)(1) 
     Upon;'' and
       (ii) by redesignating subparagraph (B) as paragraph (2); 
     and
       (C) in paragraph (2) (as so redesignated by subparagraph 
     (B)(ii))--
       (i) by striking ``subparagraph (A)'' and inserting 
     ``paragraph (1)''; and
       (ii) by striking ``this subparagraph'' each place it 
     appears and inserting ``this paragraph''.
       (b) Labeling.--Section 351(b) of the Public Health Service 
     Act (42 U.S.C. 262(b)) is amended to read as follows:
       ``(b) No person shall falsely label or mark any package or 
     container of any biological product or alter any label or 
     mark on the package or container of the biological product so 
     as to falsify the label or mark.''.
       (c) Inspection.--Section 351(c) of the Public Health 
     Service Act (42 U.S.C. 262(c)) is amended by striking 
     ``virus, serum,'' and all that follows and inserting 
     ``biological product.''.
       (d) Definition; Application.--Section 351 of the Public 
     Health Service Act (42 U.S.C. 262) is amended by adding at 
     the end the following:
       ``(i) In this section, the term `biological product' means 
     a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
     blood component or derivative, allergenic product, or 
     analogous product, or arsphenamine or derivative of 
     arsphenamine (or any other trivalent organic arsenic 
     compound), applicable to the prevention, treatment, or cure 
     of a disease or condition of human beings.''.
       (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 
     353(g)(4)) is amended--
       (1) in subparagraph (A)--
       (A) by striking ``section 351(a)'' and inserting ``section 
     351(i)''; and
       (B) by striking ``262(a)'' and inserting ``262(i)''; and
       (2) in subparagraph (B)(iii), by striking ``product or 
     establishment license under subsection (a) or (d)'' and 
     inserting ``biologics license application under subsection 
     (a)''.
       (f) Special Rule.--The Secretary of Health and Human 
     Services shall take measures to minimize differences in the 
     review and approval of products required to have approved 
     biologics license applications under section 351 of the 
     Public Health Service Act (42 U.S.C. 262) and products 
     required to have approved full new drug applications under 
     section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(b)(1)).

     SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED 
                   PRODUCTS.

       (a) Performance Standards.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services shall publish in the Federal 
     Register performance standards for the prompt review of 
     supplemental applications submitted for approved articles 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
     et seq.).
       (b) Guidance to Industry.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services shall issue final guidances to 
     clarify the requirements for, and facilitate the submission 
     of data to support, the approval of supplemental applications 
     for the approved articles described in subsection (a). The 
     guidances shall--
       (1) clarify circumstances in which published matter may be 
     the basis for approval of a supplemental application;
       (2) specify data requirements that will avoid duplication 
     of previously submitted data by recognizing the availability 
     of data previously submitted in support of an original 
     application; and
       (3) define supplemental applications that are eligible for 
     priority review.
       (c) Responsibilities of Centers.--The Secretary of Health 
     and Human Services shall designate an individual in each 
     center within the Food and Drug Administration (except the 
     Center for Food Safety and Applied Nutrition) to be 
     responsible for--
       (1) encouraging the prompt review of supplemental 
     applications for approved articles; and
       (2) working with sponsors to facilitate the development and 
     submission of data to support supplemental applications.
       (d) Collaboration.--The Secretary of Health and Human 
     Services shall implement programs and policies that will 
     foster collaboration between the Food and Drug 
     Administration, the National Institutes of Health, 
     professional medical and scientific societies, and other 
     persons, to identify published and unpublished studies that 
     may support a supplemental application, and to encourage 
     sponsors to make supplemental applications or conduct further 
     research in support of a supplemental application based, in 
     whole or in part, on such studies.

     SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

       (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is 
     amended by adding at the end the

[[Page S9857]]

     following: ``Health care economic information provided to a 
     formulary committee, or other similar entity, in the course 
     of the committee or the entity carrying out its 
     responsibilities for the selection of drugs for managed care 
     or other similar organizations, shall not be considered to be 
     false or misleading if the health care economic information 
     directly relates to an indication approved under section 505 
     or 507 or section 351(a) of the Public Health Service Act (42 
     U.S.C. 262(a)) for such drug and is based on competent and 
     reliable scientific evidence. The requirements set forth in 
     section 505(a), 507, or section 351(a) of the Public Health 
     Service Act (42 U.S.C. 262(a)) shall not apply to health care 
     economic information provided to such a committee or entity 
     in accordance with this paragraph. Information that is 
     relevant to the substantiation of the health care economic 
     information presented pursuant to this paragraph shall be 
     made available to the Secretary upon request. In this 
     paragraph, the term `health care economic information' means 
     any analysis that identifies, measures, or compares the 
     economic consequences, including the costs of the represented 
     health outcomes, of the use of a drug to the use of another 
     drug, to another health care intervention, or to no 
     intervention.''.
       (b) Study and Report.--The Comptroller General of the 
     United States shall conduct a study of the implementation of 
     the provisions added by the amendment made by subsection (a). 
     Not later than 4 years and 6 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall prepare and submit to Congress a report 
     containing the findings of the study.

     SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
     amended by section 102, is further amended by adding at the 
     end the following:

 ``Subchapter E--Fast Track Drugs and Reports of Post-Market Approval 
                                Studies

     ``SEC. 561. FAST TRACK DRUGS.

       ``(a) Designation of Drug as a Fast Track Drug.--
       ``(1) In general.--The Secretary shall facilitate 
     development, and expedite review and approval of new drugs 
     and biological products that are intended for the treatment 
     of serious or life-threatening conditions and that 
     demonstrate the potential to address unmet medical needs for 
     such conditions. In this Act, such products shall be known as 
     `fast track drugs'.
       ``(2) Request for designation.--The sponsor of a drug 
     (including a biological product) may request the Secretary to 
     designate the drug as a fast track drug. A request for the 
     designation may be made concurrently with, or at any time 
     after, submission of an application for the investigation of 
     the drug under section 505(i) or section 351(a)(4) of the 
     Public Health Service Act.
       ``(3) Designation.--Within 30 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track drug and 
     shall take such actions as are appropriate to expedite the 
     development and review of the drug.
       ``(b) Approval of Application for a Fast Track Drug.--
       ``(1) In general.--The Secretary may approve an application 
     for approval of a fast track drug under section 505(b) or 
     section 351 of the Public Health Service Act (21 U.S.C. 262) 
     upon a determination that the drug has an effect on a 
     surrogate endpoint that is reasonably likely to predict 
     clinical benefit.
       ``(2) Limitation.--Approval of a fast track drug under this 
     subsection may be subject to the requirements--
       ``(A) that the sponsor conduct appropriate post-approval 
     studies to validate the surrogate endpoint or otherwise 
     confirm the clinical benefit of the drug; and
       ``(B) that the sponsor submit copies of all promotional 
     materials related to the fast track drug during the 
     preapproval review period and following approval, at least 30 
     days prior to dissemination of the materials for such period 
     of time as the Secretary deems appropriate.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a fast track drug using expedited 
     procedures (as prescribed by the Secretary in regulations) 
     including a procedure that provides an opportunity for an 
     informal hearing, if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the fast track drug with due diligence;
       ``(B) a post-approval study of the fast track drug fails to 
     verify clinical benefit of the fast track drug;
       ``(C) other evidence demonstrates that the fast track drug 
     is not safe or effective under conditions of use of the drug; 
     or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the fast track drug.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Drug.--
       ``(1) In general.--If preliminary evaluation by the 
     Secretary of clinical efficacy data for a fast track drug 
     under investigation shows evidence of effectiveness, the 
     Secretary shall evaluate for filing, and may commence review 
     of, portions of an application for the approval of the drug 
     if the applicant provides a schedule for submission of 
     information necessary to make the application complete and 
     any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and widely disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a comprehensive description of 
     the provisions applicable to fast track drugs established 
     under this section; and
       ``(2) establish an ongoing program to encourage the 
     development of surrogate endpoints that are reasonably likely 
     to predict clinical benefit for serious or life-threatening 
     conditions for which there exist significant unmet medical 
     needs.''.
       (b) Guidance.--Within 1 year after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue guidance for fast track drugs that describes the 
     policies and procedures that pertain to section 561 of the 
     Federal Food, Drug, and Cosmetic Act.

     SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

       (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as 
     amended by section 602, is further amended by adding at the 
     end the following:

                 ``Subchapter E--Manufacturing Changes

     ``SEC. 751. MANUFACTURING CHANGES.

       ``(a) In General.--A change in the manufacture of a new 
     drug, including a biological product, or a new animal drug 
     may be made in accordance with this section.
       ``(b) Changes.--
       ``(1) Validation.--Before distributing a drug made after a 
     change in the manufacture of the drug from the manufacturing 
     process established in the approved new drug application 
     under section 505, the approved new animal drug application 
     under section 512, or the license application under section 
     351 of the Public Health Service Act, the applicant shall 
     validate the effect of the change on the identity, strength, 
     quality, purity, and potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of the drug.
       ``(2) Reports.--The applicant shall report the change 
     described in paragraph (1) to the Secretary and may 
     distribute a drug made after the change as follows:
       ``(A) Major manufacturing changes.--
       ``(i) In general.--Major manufacturing changes, which are 
     of a type determined by the Secretary to have substantial 
     potential to adversely affect the identity, strength, 
     quality, purity, or potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of a drug, shall be submitted to the 
     Secretary in a supplemental application and drugs made after 
     such changes may not be distributed until the Secretary 
     approves the supplemental application.
       ``(ii) Definition.--In this subparagraph, the term `major 
     manufacturing changes' means--

       ``(I) changes in the qualitative or quantitative 
     formulation of a drug or the specifications in the approved 
     marketing application for the drug (unless exempted by the 
     Secretary from the requirements of this subparagraph);
       ``(II) changes that the Secretary determines by regulation 
     or issuance of guidance require completion of an appropriate 
     human study demonstrating equivalence of the drug to the drug 
     manufactured before such changes; and
       ``(III) other changes that the Secretary determines by 
     regulation or issuance of guidance have a substantial 
     potential to adversely affect the safety or effectiveness of 
     the drug.

       ``(B) Other manufacturing changes.--
       ``(i) In general.--As determined by the Secretary, 
     manufacturing changes other than major manufacturing changes 
     shall--

       ``(I) be made at any time and reported annually to the 
     Secretary, with supporting data; or
       ``(II) be reported to the Secretary in a supplemental 
     application.

       ``(ii) Distribution of the drug.--In the case of changes 
     reported in accordance with clause (i)(II)--

       ``(I) the applicant may distribute the drug 30 days after 
     the Secretary receives the supplemental application unless 
     the Secretary notifies the applicant within such 30-day 
     period that prior approval of such supplemental application 
     is required;
       ``(II) the Secretary shall approve or disapprove each such 
     supplemental application; and
       ``(III) the Secretary may determine types of manufacturing 
     changes after which distribution of a drug may commence at 
     the time of submission of such supplemental application.''.

       (b) Existing Law.--The requirements of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and the Public 
     Health Service Act (42 U.S.C. 201 et seq.) that are in effect 
     on the date of enactment of this Act with respect to 
     manufacturing changes shall remain in effect--
       (1) for a period of 24 months after the date of enactment 
     of this Act; or

[[Page S9858]]

       (2) until the effective date of regulations promulgated by 
     the Secretary of Health and Human Services implementing 
     section 751 of the Federal Food, Drug, and Cosmetic Act,

     whichever is sooner.

     SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

       Within 12 months after the date of enactment of this Act, 
     the Secretary of the Health and Human Services, acting 
     through the Commissioner of Food and Drugs, shall issue 
     guidance that describes when abbreviated study reports may be 
     submitted, in lieu of full reports, with a new drug 
     application under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) and with a biologics license 
     application under section 351 of the Public Health Service 
     Act (42 U.S.C. 262) for certain types of studies. Such 
     guidance shall describe the kinds of studies for which 
     abbreviated reports are appropriate and the appropriate 
     abbreviated report formats.

     SEC. 616. FOOD CONTACT SUBSTANCES.

       (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 
     348(a)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``subsection (i)'' and inserting 
     ``subsection (j)''; and
       (B) by striking at the end ``or'';
       (2) by striking the period at the end of paragraph (2) and 
     inserting ``; or'';
       (3) by inserting after paragraph (2) the following:
       ``(3) in the case of a food additive as defined in this Act 
     that is a food contact substance, there is--
       ``(A) in effect, and such substance and the use of such 
     substance are in conformity with, a regulation issued under 
     this section prescribing the conditions under which such 
     additive may be safely used; or
       ``(B) a notification submitted under subsection (h) that is 
     effective.''; and
       (4) by striking the matter following paragraph (3) (as 
     added by paragraph (2)) and inserting the following flush 
     sentence:

     ``While such a regulation relating to a food additive, or 
     such a notification under subsection (h) relating to a food 
     additive that is a food contact substance, is in effect, and 
     has not been revoked pursuant to subsection (i), a food shall 
     not, by reason of bearing or containing such a food additive 
     in accordance with the regulation or notification, be 
     considered adulterated under section 402(a)(1).''.
       (b) Notification for Food Contact Substances.--Section 409 
     (21 U.S.C. 348), as amended by subsection (a), is further 
     amended--
       (1) by redesignating subsections (h) and (i), as 
     subsections (i) and (j), respectively;
       (2) by inserting after subsection (g) the following:

          ``Notification Relating to a Food Contact Substance

       ``(h)(1) Subject to such regulations as may be promulgated 
     under paragraph (3), a manufacturer or supplier of a food 
     contact substance may, at least 120 days prior to the 
     introduction or delivery for introduction into interstate 
     commerce of the food contact substance, notify the Secretary 
     of the identity and intended use of the food contact 
     substance, and of the determination of the manufacturer or 
     supplier that the intended use of such food contact substance 
     is safe under the standard described in subsection (c)(3)(A). 
     The notification shall contain the information that forms the 
     basis of the determination, the fee required under paragraph 
     (5), and all information required to be submitted by 
     regulations promulgated by the Secretary.
       ``(2)(A) A notification submitted under paragraph (1) shall 
     become effective 120 days after the date of receipt by the 
     Secretary and the food contact substance may be introduced or 
     delivered for introduction into interstate commerce, unless 
     the Secretary makes a determination within the 120-day period 
     that, based on the data and information before the Secretary, 
     such use of the food contact substance has not been shown to 
     be safe under the standard described in subsection (c)(3)(A), 
     and informs the manufacturer or supplier of such 
     determination.
       ``(B) A decision by the Secretary to object to a 
     notification shall constitute final agency action subject to 
     judicial review.
       ``(C) In this paragraph, the term `food contact substance' 
     means the substance that is the subject of a notification 
     submitted under paragraph (1), and does not include a similar 
     or identical substance manufactured or prepared by a person 
     other than the manufacturer identified in the notification.
       ``(3)(A) The process in this subsection shall be utilized 
     for authorizing the marketing of a food contact substance 
     except where the Secretary determines that submission and 
     review of a petition under subsection (b) is necessary to 
     provide adequate assurance of safety, or where the Secretary 
     and any manufacturer or supplier agree that such manufacturer 
     or supplier may submit a petition under subsection (b).
       ``(B) The Secretary is authorized to promulgate regulations 
     to identify the circumstances in which a petition shall be 
     filed under subsection (b), and shall consider criteria such 
     as the probable consumption of such food contact substance 
     and potential toxicity of the food contact substance in 
     determining the circumstances in which a petition shall be 
     filed under subsection (b).
       ``(4) The Secretary shall keep confidential any information 
     provided in a notification under paragraph (1) for 120 days 
     after receipt by the Secretary of the notification. After the 
     expiration of such 120 days, the information shall be 
     available to any interested party except for any matter in 
     the notification that is a trade secret or confidential 
     commercial information.
       ``(5)(A) Each person that submits a notification regarding 
     a food contact substance under this section shall be subject 
     to the payment of a reasonable fee. The fee shall be based on 
     the resources required to process the notification including 
     reasonable administrative costs for such processing.
       ``(B) The Secretary shall conduct a study of the costs of 
     administering the notification program established under this 
     section and, on the basis of the results of such study, 
     shall, within 18 months after the date of enactment of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, promulgate regulations establishing the fee 
     required by subparagraph (A).
       ``(C) A notification submitted without the appropriate fee 
     is not complete and shall not become effective for the 
     purposes of subsection (a)(3) until the appropriate fee is 
     paid.
       ``(D) Fees collected pursuant to this subsection--
       ``(i) shall not be deposited as an offsetting collection to 
     the appropriations for the Department of Health and Human 
     Services;
       ``(ii) shall be credited to the appropriate account of the 
     Food and Drug Administration; and
       ``(iii) shall be available in accordance with appropriation 
     Acts until expended, without fiscal year limitation.
       ``(6) In this section, the term `food contact substance' 
     means any substance intended for use as a component of 
     materials used in manufacturing, packing, packaging, 
     transporting, or holding food if such use is not intended to 
     have any technical effect in such food.'';
       (3) in subsection (i), as so redesignated by paragraph (1), 
     by adding at the end the following: ``The Secretary shall by 
     regulation prescribe the procedure by which the Secretary may 
     deem a notification under subsection (h) to no longer be 
     effective.''; and
       (4) in subsection (j), as so redesignated by paragraph (1), 
     by striking ``subsections (b) to (h)'' and inserting 
     ``subsections (b) to (i)''.
       (c) Effective Date.--Notifications under section 409(h) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (b), may be submitted beginning 18 months after 
     the date of enactment of this Act.

     SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.

       Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by 
     adding at the end the following:
       ``(C) Notwithstanding the provisions of clauses (A)(i) and 
     (B), a claim of the type described in subparagraph (1)(B) 
     that is not authorized by the Secretary in a regulation 
     promulgated in accordance with clause (B) shall be authorized 
     and may be made if--
       ``(i) an authoritative scientific body of the Federal 
     Government with official responsibility for public health 
     protection or research directly relating to human nutrition 
     (such as the National Institutes of Health or the Centers for 
     Disease Control and Prevention), the National Academy of 
     Sciences, or a subdivision of the scientific body or the 
     National Academy of Sciences, has published an authoritative 
     statement, which is currently in effect, about the 
     relationship between a nutrient and a disease or health-
     related condition to which the claim refers;
       ``(ii) a person has submitted to the Secretary at least 120 
     days before the first introduction of a food into interstate 
     commerce a notice of the claim, including a concise 
     description of the basis upon which such person relied for 
     determining that the requirements of subclause (i) have been 
     satisfied;
       ``(iii) the claim and the food for which the claim is made 
     are in compliance with clause (A)(ii), and are otherwise in 
     compliance with paragraph (a) and section 201(n); and
       ``(iv) the claim is stated in a manner so that the claim is 
     an accurate representation of the authoritative statement 
     referred to in subclause (i) and so that the claim enables 
     the public to comprehend the information provided in the 
     claim and to understand the relative significance of such 
     information in the context of a total daily diet.

     For purposes of this paragraph, a statement shall be regarded 
     as an authoritative statement of such a scientific body 
     described in subclause (i) only if the statement is published 
     by the scientific body and shall not include a statement of 
     an employee of the scientific body made in the individual 
     capacity of the employee.
       ``(D) A claim submitted under the requirements of clause 
     (C), may be made until--
       ``(i) such time as the Secretary issues an interim final 
     regulation--
       ``(I) under the standard in clause (B)(i), prohibiting or 
     modifying the claim; or
       ``(II) finding that the requirements of clause (C) have not 
     been met; or
       ``(ii) a district court of the United States in an 
     enforcement proceeding under chapter III has determined that 
     the requirements of clause (C) have not been met.

     Where the Secretary issues a regulation under subclause (i), 
     good cause shall be deemed to exist for the purposes of 
     subsections (b)(B) and (d)(3) of section 553 of title 5, 
     United States Code. The Secretary shall solicit comments in 
     response to a regulation promulgated under subclause (i) and 
     shall publish a response to such comments.''.

     SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       (a) General Authority.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21

[[Page S9859]]

     U.S.C. 351 et seq.) is amended by inserting after section 505 
     the following:

     ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

       ``(a) Market Exclusivity for New Drugs.--If, prior to 
     approval of an application that is submitted under section 
     505(b)(1), the Secretary determines that information relating 
     to the use of a drug in the pediatric population may produce 
     health benefits in that population, the Secretary makes a 
     written request for pediatric studies (which may include a 
     timeframe for completing such studies), and such studies are 
     completed within any such timeframe and the reports thereof 
     submitted in accordance with subsection (d)(2) or completed 
     within any such timeframe and the reports thereof are 
     accepted in accordance with subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed   
     patent   for   which   a   certification has been submitted 
     under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
     section 505, and in the patent infringement litigation 
     resulting from the certification the court determines that 
     the patent is valid and would be infringed, the period during 
     which an application may not be approved under subsection 
     (c)(3) or (j)(4)(B) of section 505 shall be extended by a 
     period of six months after the date the patent expires 
     (including any patent extensions).
       ``(b) Secretary To Develop List of Drugs for Which 
     Additional Pediatric Information May Be Beneficial.--Not 
     later than 180 days after the date of enactment of this 
     section, the Secretary, after consultation with experts in 
     pediatric research (such as the American Academy of 
     Pediatrics, the Pediatric Pharmacology Research Unit Network, 
     and the United States Pharmacopoeia) shall develop, 
     prioritize, and publish an initial list of approved drugs for 
     which additional pediatric information may produce health 
     benefits in the pediatric population. The Secretary shall 
     annually update the list.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--If 
     the Secretary makes a written request for pediatric studies 
     (which may include a timeframe for completing such studies) 
     concerning a drug identified in the list described in 
     subsection (b) to the holder of an approved application under 
     section 505(b)(1) for the drug, the holder agrees to the 
     request, and the studies are completed within any such 
     timeframe and the reports thereof submitted in accordance 
     with subsection (d)(2) or completed within any such timeframe 
     and the reports thereof accepted in accordance with 
     subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification  has  been 
      submitted  under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed 
     patent   for   which   a   certification   has   been 
     submitted under subsection (b)(2)(A)(iv) or 
     (j)(2)(A)(vii)(IV) of section 505, and in the patent 
     infringement litigation resulting from the certification the 
     court determines that the patent is valid and would be 
     infringed, the period during which an application may not be 
     approved under subsection (c)(3) or (j)(4)(B) of section 505 
     shall be extended by a period of six months after the date 
     the patent expires (including any patent extensions).
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Agreement for studies.--The Secretary may, pursuant 
     to a written request for studies, after consultation with--
       ``(A) the sponsor of an application for an investigational 
     new drug under section 505(i);
       ``(B) the sponsor of an application for a drug under 
     section 505(b)(1); or
       ``(C) the holder of an approved application for a drug 
     under section 505(b)(1),

     agree with the sponsor or holder for the conduct of pediatric 
     studies for such drug.
       ``(2) Written protocols to meet the studies requirement.--
     If the sponsor or holder and the Secretary agree upon written 
     protocols for the studies, the studies requirement of 
     subsection (a) or (c) is satisfied upon the completion of the 
     studies and submission of the reports thereof in accordance 
     with the original written request and the written agreement 
     referred to in paragraph (1). Not later than 60 days after 
     the submission of the report of the studies, the Secretary 
     shall determine if such studies were or were not conducted in 
     accordance with the original written request and the written 
     agreement and reported in accordance with the requirements of 
     the Secretary for filing and so notify the sponsor or holder.
       ``(3) Other methods to meet the studies requirement.--If 
     the sponsor or holder and the Secretary have not agreed in 
     writing on the protocols for the studies, the studies 
     requirement of subsection (a) or (c) is satisfied when such 
     studies have been completed and the reports accepted by the 
     Secretary. Not later than 90 days after the submission of the 
     reports of the studies, the Secretary shall accept or reject 
     such reports and so notify the sponsor or holder. The 
     Secretary's only responsibility in accepting or rejecting the 
     reports shall be to determine, within the 90 days, whether 
     the studies fairly respond to the written request, whether 
     such studies have been conducted in accordance with commonly 
     accepted scientific principles and protocols, and whether 
     such studies have been reported in accordance with the 
     requirements of the Secretary for filing.
       ``(e) Delay of Effective Date for Certain Applications; 
     Period of Market Exclusivity.--If the Secretary determines 
     that the acceptance or approval of an application under 
     subsection (b)(2) or (j) of section 505 for a drug may occur 
     after submission of reports of pediatric studies under this 
     section, which were submitted prior to the expiration of the 
     patent (including any patent extension) or market exclusivity 
     protection, but before the Secretary has determined whether 
     the requirements of subsection (d) have been satisfied, the 
     Secretary shall delay the acceptance or approval under 
     subsection (b)(2) or (j), respectively, of section 505 until 
     the determination under subsection (d) is made, but such 
     delay shall not exceed 90 days. In the event that 
     requirements of this section are satisfied, the applicable 
     period of market exclusivity referred to in subsection (a) or 
     (c) shall be deemed to have been running during the period of 
     delay.
       ``(f) Notice of Determinations on Studies Requirement.--The 
     Secretary shall publish a notice of any determination that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section.
       ``(g) Limitation.--The holder of an approved application 
     for a new drug that has already received six months of market 
     exclusivity under subsection (a) or (c) may, if otherwise 
     eligible, obtain six months of market exclusivity under 
     subsection (c)(1)(B) for a supplemental application, except 
     that the holder is not eligible for exclusivity under 
     subsection (c)(2).
       ``(h) Study and Report.--The Secretary shall conduct a 
     study and report to Congress not later than January 1, 2003 
     based on the experience under the program. The study and 
     report shall examine all relevant issues, including--
       ``(1) the effectiveness of the program in improving 
     information about important pediatric uses for approved 
     drugs;
       ``(2) the adequacy of the incentive provided under this 
     section;
       ``(3) the economic impact of the program; and
       ``(4) any suggestions for modification that the Secretary 
     deems appropriate.
       ``(i) Termination of Market Exclusivity Extension Authority 
     for New Drugs.--Except as provided in section 618(b) of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, no period of market exclusivity shall be 
     extended under subsection (a) for a drug if--
       ``(1) the extension would be based on studies commenced 
     after January 1, 2004; and
       ``(2) the application submitted for the drug under section 
     505(b)(1) was not approved by January 1, 2004.
       ``(j) Definitions.--In this section, the term `pediatric 
     studies' or `studies' means at least 1 clinical investigation 
     (that, at the Secretary's discretion, may include 
     pharmacokinetic studies) in pediatric age-groups in which a 
     drug is anticipated to be used.''.
       (b) Market Exclusivity Under Other Authority.--

[[Page S9860]]

       (1) Through calendar year 2003.--
       (A) Determination.--If the Secretary requests or requires 
     pediatric studies, prior to January 1, 2004, under Federal 
     law other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)), from the sponsor 
     of an application, or the holder of an approved application, 
     for a drug under section 505(b) of such Act (21 U.S.C. 
     355(b)), the Secretary shall determine whether the studies 
     meet the completeness, timeliness, and other submission 
     requirements of the Federal law involved.
       (B) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (2) Calendar year 2004 and subsequent years.--
       (A) New drugs.--Effective January 1, 2004, if the Secretary 
     requests or requires pediatric studies, under Federal law 
     other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act, from the sponsor of an application for a drug 
     under section 505(b) of such Act, nothing in such law shall 
     be construed to permit or require the Secretary to ensure 
     that the period of market exclusivity for the drug is 
     extended.
       (B) Already marketed drugs.--
       (i) Determination.--Effective January 1, 2004, if the 
     Secretary requests or requires pediatric studies, under 
     Federal law other than section 505A of the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (a)), from the 
     holder of an approved application for a drug under section 
     505(b) of such Act, the Secretary shall determine whether the 
     studies meet the completeness, timeliness, and other 
     submission requirements of the Federal law involved.
       (ii) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (3) Definitions.--In this subsection:
       (A) Drug.--The term ``drug'' has the meaning given the term 
     in section 201 of such Act.
       (B) Pediatric studies.--The term ``pediatric studies'' has 
     the meaning given the term in section 505A of such Act.
       (C) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

     SEC. 619. POSITRON EMISSION TOMOGRAPHY.

       (a) Regulation of Compounded Positron Emission Tomography 
     Drugs Under the Federal Food, Drug, and Cosmetic Act.--
       (1) Definition.--Section 201 (21 U.S.C. 321) is amended by 
     adding at the end the following:
       ``(ii) The term `compounded positron emission tomography 
     drug'--
       ``(1) means a drug that--
       ``(A) exhibits spontaneous disintegration of unstable 
     nuclei by the emission of positrons and is used for the 
     purpose of providing dual photon positron emission 
     tomographic diagnostic images; and
       ``(B) has been compounded by or on the order of a 
     practitioner who is licensed by a State to compound or order 
     compounding for a drug described in subparagraph (A), and is 
     compounded in accordance with that State's law, for a patient 
     or for research, teaching, or quality control; and
       ``(2) includes any nonradioactive reagent, reagent kit, 
     ingredient, nuclide generator, accelerator, target material, 
     electronic synthesizer, or other apparatus or computer 
     program to be used in the preparation of such a drug.''.
       (b) Adulteration.--
       (1) In general.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) is 
     amended by striking ``; or (3)'' and inserting the following: 
     ``; or (C) if it is a compounded positron emission tomography 
     drug and the methods used in, or the facilities and controls 
     used for, its compounding, processing, packing, or holding do 
     not conform to or are not operated or administered in 
     conformity with the positron emission tomography compounding 
     standards and the official monographs of the United States 
     Pharmacopeia to assure that such drug meets the requirements 
     of this Act as to safety and has the identity and strength, 
     and meets the quality and purity characteristics, that it 
     purports or is represented to possess; or (3)''.
       (2) Sunset.--Section 501(a)(2)(C) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not 
     apply 4 years after the date of enactment of this Act or 2 
     years after the date or which the Secretary of Health and 
     Human Services establishes the requirements described in 
     subsection (c)(1)(B), whichever is later.
       (c) Requirements for Review of Approval Procedures and 
     Current Good Manufacturing Practices for Positron Emission 
     Tomography.--
       (1) Procedures and requirements.--
       (A) In general.--In order to take account of the special 
     characteristics of compounded positron emission tomography 
     drugs and the special techniques and processes required to 
     produce these drugs, not later than 2 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall establish--
       (i) appropriate procedures for the approval of compounded 
     positron emission tomography drugs pursuant to section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
       (ii) appropriate current good manufacturing practice 
     requirements for such drugs.
       (B) Considerations and consultation.--In establishing the 
     procedures and requirements required by subparagraph (A), the 
     Secretary of Health and Human Services shall take due account 
     of any relevant differences between not-for-profit 
     institutions that compound the drugs for their patients and 
     commercial manufacturers of the drugs. Prior to establishing 
     the procedures and requirements, the Secretary of Health and 
     Human Services shall consult with patient advocacy groups, 
     professional associations, manufacturers, and physicians and 
     scientists licensed to make or use compounded positron 
     emission tomography drugs.
       (2) Submission of new drug applications and abbreviated new 
     drug applications.--
       (A) In general.--Except as provided in subparagraph (B), 
     the Secretary of Health and Human Services shall not require 
     the submission of new drug applications or abbreviated new 
     drug applications under subsection (b) or (j) of section 505 
     (21 U.S.C. 355), for compounded positron emission tomography 
     drugs that are not adulterated drugs described in section 
     501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a 
     period of 4 years after the date of enactment of this Act, or 
     for 2 years after the date or which the Secretary establishes 
     procedures and requirements under paragraph (1), whichever is 
     later.
       (B) Exception.--Nothing in this Act shall prohibit the 
     voluntary submission of such applications or the review of 
     such applications by the Secretary of Health and Human 
     Services. Nothing in this Act shall constitute an exemption 
     for a compounded positron emission tomography drug from the 
     requirements of regulations issued under section 505(i) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 
     for such drugs.
       (d) Revocation of Certain Inconsistent Documents.--Within 
     30 days after the date of enactment of this Act, the 
     Secretary of Health and Human Services shall publish in the 
     Federal Register a notice terminating the application of the 
     following notices and rule, to the extent the notices and 
     rule relate to compounded positron emission tomography drugs:
       (1) A notice entitled ``Regulation of Positron Emission 
     Tomographic Drug Products: Guidance; Public Workshop'', 
     published in the Federal Register on February 27, 1995.
       (2) A notice entitled ``Guidance for Industry: Current Good 
     Manufacturing Practices for Positron Emission Tomographic 
     (PET) Drug Products; Availability'', published in the Federal 
     Register on April 22, 1997.
       (3) A final rule entitled ``Current Good Manufacturing 
     Practice for Finished Pharmaceuticals; Positron Emission 
     Tomography'', published in the Federal Register on April 22, 
     1997.
       (e) Definition.--As used in this section, the term 
     ``compounded positron emission tomography drug'' has the 
     meaning given the term in section 201 of the Federal Food, 
     Drug and Cosmetic Act (21 U.S.C. 321).

     SEC. 620. DISCLOSURE.

       Chapter IV (21 U.S.C. 341 et seq.) is amended by adding 
     after section 403B the following:


                              ``disclosure

       ``Sec. 403C. (a) No provision of section 403(a), 201(n), or 
     409 shall be construed to require on the label or labeling of 
     a food a separate radiation disclosure statement that is more 
     prominent than the declaration of ingredients required by 
     section 403(i)(2).
       ``(b) In this section, the term `radiation disclosure 
     statement' means a written statement that discloses that a 
     food or a component of the food has been intentionally 
     subject to radiation.''.

     SEC. 621. REFERRAL STATEMENTS RELATING TO FOOD NUTRIENTS.

       Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to 
     read as follows:
       ``(B) If a claim described in subparagraph (1)(A) is made 
     with respect to a nutrient in a food, and the Secretary makes 
     a determination that the food contains a nutrient at a level 
     that increases to persons in the general population the risk 
     of a disease or health-related condition that is diet 
     related, then the label or labeling of such food shall 
     contain, prominently and in immediate proximity to such 
     claim, the following statement: `See nutrition information 
     panel for __ content.' The blank shall identify the nutrient 
     associated with the increased disease or health-related 
     condition risk. In making the determination described in this 
     clause, the Secretary shall take into account the 
     significance of the food in the total daily diet.''.
                   TITLE VII--FEES RELATING TO DRUGS

     SEC. 701. SHORT TITLE.

       This title may be cited as the ``Prescription Drug User Fee 
     Reauthorization Act of 1997''.

     SEC. 702. FINDINGS.

       Congress finds that--
       (1) prompt approval of safe and effective new drugs and 
     other therapies is critical to the improvement of the public 
     health so that patients may enjoy the benefits provided by 
     these therapies to treat and prevent illness and disease;
       (2) the public health will be served by making additional 
     funds available for the purpose of augmenting the resources 
     of the Food

[[Page S9861]]

     and Drug Administration that are devoted to the process for 
     review of human drug applications;
       (3) the provisions added by the Prescription Drug User Fee 
     Act of 1992 have been successful in substantially reducing 
     review times for human drug applications and should be--
       (A) reauthorized for an additional 5 years, with certain 
     technical improvements; and
       (B) carried out by the Food and Drug Administration with 
     new commitments to implement more ambitious and comprehensive 
     improvements in regulatory processes of the Food and Drug 
     Administration; and
       (4) the fees authorized by amendments made in this title 
     will be dedicated toward expediting the drug development 
     process and the review of human drug applications as set 
     forth in the goals identified in appropriate letters from the 
     Secretary of Health and Human Services to the chairman of the 
     Committee on Commerce of the House of Representatives and the 
     chairman of the Committee on Labor and Human Resources of the 
     Senate.

     SEC. 703. DEFINITIONS.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) in the second sentence of paragraph (1)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include an 
     application for a licensure of a biological product for 
     further manufacturing use only, and does not include an 
     application or supplement submitted by a State or Federal 
     Government entity for a drug or biological product that is 
     not distributed commercially. Such term does include an 
     application for licensure, as described in subparagraph (D), 
     of a large volume biological product intended for single dose 
     injection for intravenous use or infusion.'';
       (2) in the second sentence of paragraph (3)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include a biological 
     product that is licensed for further manufacturing use only, 
     and does not include a drug or biological product that is not 
     distributed commercially and is the subject of an application 
     or supplement submitted by a State or Federal Government 
     entity. Such term does include a large volume biological 
     product intended for single dose injection for intravenous 
     use or infusion.'';
       (3) in paragraph (4), by striking ``without'' and inserting 
     ``without substantial'';
       (4) by striking paragraph (5) and inserting the following:
       ``(5) The term `prescription drug establishment' means a 
     foreign or domestic place of business which is at 1 general 
     physical location consisting of 1 or more buildings all of 
     which are within 5 miles of each other, at which 1 or more 
     prescription drug products are manufactured in final dosage 
     forms.'';
       (5) in paragraph (7)(A)--
       (A) by striking ``employees under contract'' and all that 
     follows through ``Administration,'' and inserting 
     ``contractors of the Food and Drug Administration,''; and
       (B) by striking ``and committees,'' and inserting ``and 
     committees and to contracts with such contractors,'';
       (6) in paragraph (8)--
       (A) in subparagraph (A)--
       (i) by striking ``August of '' and inserting ``April of ''; 
     and
       (ii) by striking ``August 1992'' and inserting ``April 
     1997'';
       (B) by striking subparagraph (B) and inserting the 
     following:
       ``(B) 1 plus the decimal expression of the total percentage 
     increase for such fiscal year since fiscal year 1997 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.''; and
       (C) by striking the second sentence; and
       (7) by adding at the end the following:
       ``(9) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) 1 business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control both 
     of the business entities.''.

     SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) by striking ``Beginning in fiscal year 1993'' and 
     inserting ``Beginning in fiscal year 1998'';
       (2) in paragraph (1)--
       (A) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the application or supplement.'';
       (B) in subparagraph (D)--
       (i) in the subparagraph heading, by striking ``not 
     accepted'' and inserting ``refused'';
       (ii) by striking ``50 percent'' and inserting ``75 
     percent'';
       (iii) by striking ``subparagraph (B)(i)'' and inserting 
     ``subparagraph (B)''; and
       (iv) by striking ``not accepted'' and inserting 
     ``refused''; and
       (C) by adding at the end the following:
       ``(E) Exception for designated orphan drug or indication.--
     A human drug application for a prescription drug product that 
     has been designated as a drug for a rare disease or condition 
     pursuant to section 526 shall not be subject to a fee under 
     subparagraph (A), unless the human drug application includes 
     indications for other than rare diseases or conditions. A 
     supplement proposing to include a new indication for a rare 
     disease or condition in a human drug application shall not be 
     subject to a fee under subparagraph (A), provided that the 
     drug has been designated pursuant to section 526 as a drug 
     for a rare disease or condition with regard to the indication 
     proposed in such supplement.
       ``(F) Exception for supplements for pediatric 
     indications.--A supplement to a human drug application for an 
     indication for use in pediatric populations shall not be 
     assessed a fee under subparagraph (A).
       ``(G) Refund of fee if application withdrawn.--If an 
     application or supplement is withdrawn after the application 
     or supplement is filed, the Secretary may waive and refund 
     the fee or a portion of the fee if no substantial work was 
     performed on the application or supplement after the 
     application or supplement was filed. The Secretary shall have 
     the sole discretion to waive and refund a fee or a portion of 
     the fee under this subparagraph. A determination by the 
     Secretary concerning a waiver or refund under this paragraph 
     shall not be reviewable.'';
       (3) by striking paragraph (2) and inserting the following:
       ``(2) Prescription drug establishment fee.--
       ``(A) In general.--Each person that--
       ``(i) is named as the applicant in a human drug 
     application; and
       ``(ii) after September 1, 1992, had pending before the 
     Secretary a human drug application or supplement;

     shall be assessed an annual fee established in subsection (b) 
     for each prescription drug establishment listed in its 
     approved human drug application as an establishment that 
     manufactures the prescription drug product named in the 
     application. The annual establishment fee shall be assessed 
     in each fiscal year in which the prescription drug product 
     named in the application is assessed a fee under paragraph 
     (3) unless the prescription drug establishment listed in the 
     application does not engage in the manufacture of the 
     prescription drug product during the fiscal year. The 
     establishment fee shall be payable on or before January 31 of 
     each year. Each such establishment shall be assessed only 1 
     fee per establishment, notwithstanding the number of 
     prescription drug products manufactured at the establishment. 
     In the event an establishment is listed in a human drug 
     application by more than 1 applicant, the establishment fee 
     for the fiscal year shall be divided equally and assessed 
     among the applicants whose prescription drug products are 
     manufactured by the establishment during the fiscal year and 
     assessed product fees under paragraph (3).
       ``(B) Exception.--If, during the fiscal year, an applicant 
     initiates or causes to be initiated the manufacture of a 
     prescription drug product at an establishment listed in its 
     human drug application--
       ``(i) that did not manufacture the product in the previous 
     fiscal year; and
       ``(ii) for which the full establishment fee has been 
     assessed in the fiscal year at a time before manufacture of 
     the prescription drug product was begun;

     the applicant will not be assessed a share of the 
     establishment fee for the fiscal year in which manufacture of 
     the product began.''; and
       (4) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``is listed'' and inserting 
     ``has been submitted for listing''; and
       (ii) by striking ``Such fee shall be payable'' and all that 
     follows through ``section 510.'' and inserting the following: 
     ``Such fee shall be payable for the fiscal year in which the 
     product is first submitted for listing under section 510, or 
     for relisting under section 510 if the product has been 
     withdrawn from listing and relisted. After such fee is paid 
     for that fiscal year, such fee shall be payable on or before 
     January 31 of each year. Such fee shall be paid only once for 
     each product for a fiscal year in which the fee is 
     payable.''; and
       (B) in subparagraph (B), by striking ``505(j).'' and 
     inserting the following: ``505(j), or under an abbreviated 
     new drug application pursuant to regulations in effect prior 
     to the implementation of the Drug Price Competition and 
     Patent Term Restoration Act of 1984, or is a product approved 
     under an application filed under section 507 that is 
     abbreviated.''.
       (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), (f), and (g), the fees required under subsection (a) 
     shall be determined and assessed as follows:
       ``(1) Application and supplement fees.--
       ``(A) Full fees.--The application fee under subsection 
     (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 
     in each of fiscal years 1999 and 2000, $267,606 in fiscal 
     year 2001, and $258,451 in fiscal year 2002.
       ``(B) Other fees.--The fee under subsection (a)(1)(A)(ii) 
     shall be $125,352 in fiscal year 1998, $128,169 in each of 
     fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and 
     $129,226 in fiscal year 2002.
       ``(2) Fee revenues for establishment fees.--The total fee 
     revenues to be collected

[[Page S9862]]

     in establishment fees under subsection (a)(2) shall be 
     $35,600,000 in fiscal year 1998, $36,400,000 in each of 
     fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, 
     and $36,700,000 in fiscal year 2002.
       ``(3) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(3) in a fiscal year shall be equal to the total fee 
     revenues collected in establishment fees under subsection 
     (a)(2) in that fiscal year.''.
       (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (1) in the subsection heading, by striking ``Increases 
     and'';
       (2) in paragraph (1)--
       (A) by striking ``(1) Revenue'' and all that follows 
     through ``increased by the Secretary'' and inserting the 
     following: ``(1) Inflation adjustment.--The fees and total 
     fee revenues established in subsection (b) shall be adjusted 
     by the Secretary'';
       (B) in subparagraph (A), by striking ``increase'' and 
     inserting ``change'';
       (C) in subparagraph (B), by striking ``increase'' and 
     inserting ``change''; and
       (D) by adding at the end the following flush sentence:

     ``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 1997 
     under this subsection.'';
       (3) in paragraph (2), by striking ``October 1, 1992,'' and 
     all that follows through ``such schedule.'' and inserting the 
     following: ``September 30, 1997, adjust the establishment and 
     product fees described in subsection (b) for the fiscal year 
     in which the adjustment occurs so that the revenues collected 
     from each of the categories of fees described in paragraphs 
     (2) and (3) of subsection (b) shall be set to be equal to the 
     revenues collected from the category of application and 
     supplement fees described in paragraph (1) of subsection 
     (b).''; and
       (4) in paragraph (3), by striking ``paragraph (2)'' and 
     inserting ``this subsection''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) by redesignating paragraphs (1), (2), (3), and (4) as 
     subparagraphs (A), (B), (C), and (D), respectively, and 
     indenting appropriately;
       (2) by striking ``The Secretary shall grant a'' and all 
     that follows through ``finds that--'' and inserting the 
     following:
       ``(1) In general.--The Secretary shall grant a waiver from 
     or a reduction of 1 or more fees assessed under subsection 
     (a) where the Secretary finds that--'';
       (3) in subparagraph (C) (as so redesignated by paragraph 
     (1)), by striking ``, or'' and inserting a comma;
       (4) in subparagraph (D) (as so redesignated by paragraph 
     (1)), by striking the period and inserting ``, or'';
       (5) by inserting after subparagraph (D) (as so redesignated 
     by paragraph (1)) the following:
       ``(E) the applicant is a small business submitting its 
     first human drug application to the Secretary for review.''; 
     and
       (6) by striking ``In making the finding in paragraph (3),'' 
     and all that follows through ``standard costs.'' and 
     inserting the following:
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(C), the Secretary may use standard costs.
       ``(3) Rules relating to small businesses.--
       ``(A) Definition.--In paragraph (1)(E), the term `small 
     business' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(E) the application fee for the first 
     human drug application that a small business or its affiliate 
     submits to the Secretary for review. After a small business 
     or its affiliate is granted such a waiver, the small business 
     or its affiliate shall pay--
       ``(i) application fees for all subsequent human drug 
     applications submitted to the Secretary for review in the 
     same manner as an entity that does not qualify as a small 
     business; and
       ``(ii) all supplement fees for all supplements to human 
     drug applications submitted to the Secretary for review in 
     the same manner as an entity that does not qualify as a small 
     business.''.
       (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 
     379h(f)(1)) is amended--
       (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
     year 1997''; and
       (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
     year 1997 (excluding the amount of fees appropriated for such 
     fiscal year)''.
       (f) Crediting and Availability of Fees.--Section 736(g) (21 
     U.S.C. 379h(g)) is amended--
       (1) in paragraph (1), by adding at the end the following: 
     ``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 review of human drug 
     applications within the meaning of section 735(6).'';
       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``Acts'' and inserting 
     ``Acts, or otherwise made available for obligation,''; and
       (B) in subparagraph (B), by striking ``over such costs for 
     fiscal year 1992'' and inserting ``over such costs, excluding 
     costs paid from fees collected under this section, for fiscal 
     year 1997''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Authorization of appropriations.--There is authorized 
     to be appropriated for fees under this section--
       ``(A) $106,800,000 for fiscal year 1998;
       ``(B) $109,200,000 for fiscal year 1999;
       ``(C) $109,200,000 for fiscal year 2000;
       ``(D) $114,000,000 for fiscal year 2001; and
       ``(E) $110,100,000 for fiscal year 2002,
     as adjusted to reflect adjustments in the total fee revenues 
     made under this section and changes in the total amounts 
     collected by application, supplement, establishment, and 
     product fees.
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year which 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 authorized to be 
     collected under appropriation Acts for a subsequent fiscal 
     year.''.
       (g) Requirement for Written Requests for Waivers, 
     Reductions, and Fees.--Section 736 (21 U.S.C. 379h) is 
     amended--
       (1) by redesignating subsection (i) as subsection (j); and
       (2) by inserting after subsection (h) the following:
       ``(i) Written Requests for Waivers, Reductions, and 
     Refunds.--To qualify for consideration for a waiver or 
     reduction under subsection (d), or for a refund, of any fee 
     collected in accordance with subsection (a), a person shall 
     submit to the Secretary a written request for such waiver, 
     reduction, or refund not later than 180 days after such fee 
     is due.''.
       (h) Special Rule for Waiver, Refunds, and Exceptions.--Any 
     requests for waivers, refunds, or exceptions for fees paid 
     prior to the date of enactment of this Act shall be submitted 
     in writing to the Secretary of Health and Human Services 
     within 1 year after the date of enactment of this Act.

     SEC. 705. ANNUAL REPORTS.

       (a) First Report.--Beginning with fiscal year 1998, not 
     later than 60 days after the end of each fiscal year during 
     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 shall prepare and submit to the Committee on 
     Commerce of the House of Representatives and the Committee on 
     Labor and Human Resources of the Senate a report concerning 
     the progress of the Food and Drug Administration in achieving 
     the goals identified in the letter described in section 
     702(4) during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals.
       (b) Second Report.--Beginning with fiscal year 1998, not 
     later than 120 days after the end of each fiscal year during 
     which fees are collected under the part described in 
     subsection (a), the Secretary of Health and Human Services 
     shall prepare and submit to the Committee on Commerce of the 
     House of Representatives and the Committee on Labor and Human 
     Resources 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 
     during such fiscal year for which the report is made.

     SEC. 706. EFFECTIVE DATE.

       The amendments made by this title shall take effect October 
     1, 1997.

     SEC. 707. TERMINATION OF EFFECTIVENESS.

       The amendments made by sections 703 and 704 cease to be 
     effective October 1, 2002 and section 705 ceases to be 
     effective 120 days after such date.
                       TITLE VIII--MISCELLANEOUS

     SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.

       Section 510(i) (21 U.S.C. 360(i)) is amended to read as 
     follows:
       ``(i)(1) Any establishment within any foreign country 
     engaged in the manufacture, preparation, propagation, 
     compounding, or processing of a drug or a device that is 
     imported or offered for import into the United States shall 
     register with the Secretary the name and place of business of 
     the establishment and the name of the United States agent for 
     the establishment.
       ``(2) The establishment shall also provide the information 
     required by subsection (j).
       ``(3) The Secretary is authorized to enter into cooperative 
     arrangements with foreign countries to ensure that adequate 
     and effective means are available for purposes of 
     determining, from time to time, whether drugs or devices 
     manufactured, prepared, propagated, compounded, or processed 
     by an establishment described in paragraph (1), if imported 
     or offered for import into the United States, shall be 
     refused admission on any of the grounds set forth in section 
     801(a).''.

     SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

       (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 
     353(b)(4)) is amended to read as follows:
       ``(4)(A) A drug that is subject to paragraph (1) shall be 
     deemed to be misbranded if at any time prior to dispensing 
     the label of the drug fails to bear, at a minimum, the symbol 
     `Rx only'.
       ``(B) A drug to which paragraph (1) does not apply shall be 
     deemed to be misbranded

[[Page S9863]]

     if at any time prior to dispensing the label of the drug 
     bears the symbol described in subparagraph (A).''.
       (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
     repealed.
       (c) Conforming Amendments.--
       (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
       (A) by striking subparagraph (A); and
       (B) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (A) and (B), respectively.
       (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
     striking ``section 502(d) and''.
       (3) Section 102(9)(A) of the Controlled Substances Act (21 
     U.S.C. 802(9)(A)) is amended--
       (A) in clause (i), by striking ``(i)''; and
       (B) by striking ``(ii)'' and all that follows.

     SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

       Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
       (1) in the fifth sentence, by striking ``paragraphs (1) and 
     (2) of section 801(e)'' and inserting ``subparagraphs (A) and 
     (B) of section 801(e)(1)''; and
       (2) by inserting after the fifth sentence the following: 
     ``Any person seeking to export an imported article pursuant 
     to any of the provisions of this subsection shall establish 
     that the article was intended for export at the time the 
     article entered commerce.''.

     SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     203, is further amended by adding at the end the following:

     ``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may, directly or through 
     grants, contracts, or cooperative agreements, conduct and 
     support intramural research training in regulatory scientific 
     programs by predoctoral and postdoctoral scientists and 
     physicians, including support through the use of fellowships.
       ``(b) Limitation on Participation.--A recipient of a 
     fellowship under subsection (a) may not be an employee of the 
     Federal Government.
       ``(c) Special Rule.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may support the provision of 
     assistance for fellowships described in subsection (a) 
     through a Cooperative Research and Development Agreement.''.

     SEC. 805. DEVICE SAMPLES.

       (a) Recall Authority.--
       (1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2)) 
     is amended by adding at the end the following:
       ``(C) If the Secretary issues an amended order under 
     subparagraph (A), the Secretary may require the person 
     subject to the order to submit such samples of the device and 
     of components of the device as the Secretary may reasonably 
     require. If the submission of such samples is impracticable 
     or unduly burdensome, the requirement of this subparagraph 
     may be met by the submission of complete information 
     concerning the location of 1 or more such devices readily 
     available for examination and testing.''.
       (2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C. 
     360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and 
     (C)'' and inserting ``subparagraph (B)''.
       (b) Records and Reports on Devices.--Section 519(a) (21 
     U.S.C. 360i(a)) is amended by inserting after paragraph (9) 
     the following:
       ``(10) may reasonably require a manufacturer or importer to 
     submit samples of a device and of components of the device 
     that may have caused or contributed to a death or serious 
     injury, except that if the submission of such samples is 
     impracticable or unduly burdensome, the requirement of this 
     paragraph may be met by the submission of complete 
     information concerning the location of 1 or more such devices 
     readily available for examination and testing.''.

     SEC. 806. INTERSTATE COMMERCE.

       Section 709 (21 U.S.C. 379a) is amended by striking ``a 
     device'' and inserting ``a device, food, drug, or cosmetic''.

     SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                   COSMETICS.

       (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et 
     seq.), as amended by section 614(a), is further amended by 
     adding at the end the following:

   ``Subchapter F--National Uniformity for Nonprescription Drugs and 
           Preemption for Labeling or Packaging of Cosmetics

     ``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.

       ``(a) In General.--Except as provided in subsection (b), 
     (c)(1), (d), (e), or (f), no State or political subdivision 
     of a State may establish or continue in effect any 
     requirement--
       ``(1) that relates to the regulation of a drug that is not 
     subject to the requirements of section 503(b)(1) or 
     503(f)(1)(A); and
       ``(2) that is different from or in addition to, or that is 
     otherwise not identical with, a requirement under this Act, 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 
     1451 et seq.).
       ``(b) Exemption.--
       ``(1) In general.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation, after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement that--
       ``(A) protects an important public interest that would 
     otherwise be unprotected, including the health and safety of 
     children;
       ``(B) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(C) would not unduly burden interstate commerce.
       ``(2) Timely action.--The Secretary shall make a decision 
     on the exemption of a State or political subdivision 
     requirement under paragraph (1) not later than 120 days after 
     receiving the application of the State or political 
     subdivision under paragraph (1).
       ``(c) Scope.--
       ``(1) In general.--This section shall not apply to--
       ``(A) any State or political subdivision requirement that 
     relates to the practice of pharmacy; or
       ``(B) any State or political subdivision requirement that a 
     drug be dispensed only upon the prescription of a 
     practitioner licensed by law to administer such drug.
       ``(2) Safety or effectiveness.--For purposes of subsection 
     (a), a requirement that relates to the regulation of a drug 
     shall be deemed to include any requirement relating to public 
     information or any other form of public communication 
     relating to a warning of any kind for a drug.
       ``(d) Exceptions.--
       ``(1) In general.--In the case of a drug described in 
     subsection (a)(1) that is not the subject of an application 
     approved under section 505 or 507 or a final regulation 
     promulgated by the Secretary establishing conditions under 
     which the drug is generally recognized as safe and effective 
     and not misbranded, subsection (a) shall apply only with 
     respect to a requirement of a State or political subdivision 
     of a State that relates to the same subject as, but is 
     different from or in addition to, or that is otherwise not 
     identical with--
       ``(A) a regulation in effect with respect to the drug 
     pursuant to a statute described in subsection (a)(2); or
       ``(B) any other requirement in effect with respect to the 
     drug pursuant to an amendment to such a statute made on or 
     after the date of enactment of this section.
       ``(2) State initiatives.--This section shall not apply to a 
     State public initiative enacted prior to the date of 
     enactment of this section.
       ``(e) No Effect on Product Liability Law.--Nothing in this 
     section shall be construed to modify or otherwise affect any 
     action or the liability of any person under the product 
     liability law of any State.
       ``(f) State Enforcement Authority.--Nothing in this section 
     shall prevent a State or political subdivision thereof from 
     enforcing, under any relevant civil or other enforcement 
     authority, a requirement that is identical to a requirement 
     of this Act.''.
       (b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) 
     is amended by striking ``prescription drugs'' each place it 
     appears and inserting ``prescription drugs, nonprescription 
     drugs intended for human use,''.
       (c) Misbranding.--Paragraph (1) of section 502(e) (21 
     U.S.C. 352(e)(1)) is amended to read as follows:
       ``(1)(A) If it is a drug, unless its label bears, to the 
     exclusion of any other nonproprietary name (except the 
     applicable systematic chemical name or the chemical 
     formula)--
       ``(i) the established name (as defined in subparagraph (3)) 
     of the drug, if there is such a name;
       ``(ii) the established name and quantity or, if deemed 
     appropriate by the Secretary, the proportion of each active 
     ingredient, including the quantity, kind, and proportion of 
     any alcohol, and also including whether active or not the 
     established name and quantity or if deemed appropriate by the 
     Secretary, the proportion of any bromides, ether, chloroform, 
     acetanilide, acetophenetidin, amidopyrine, antipyrine, 
     atropine, hyoscine, hyoscyamine, arsenic, digitalis, 
     digitalis glucosides, mercury, ouabain, strophanthin, 
     strychnine, thyroid, or any derivative or preparation of any 
     such substances, contained therein: Provided, That the 
     requirement for stating the quantity of the active 
     ingredients, other than the quantity of those specifically 
     named in this paragraph, shall not apply to nonprescription 
     drugs not intended for human use; and
       ``(iii) the established name of each inactive ingredient 
     listed in alphabetical order on the outside container of the 
     retail package and, if deemed appropriate by the Secretary, 
     on the immediate container, as prescribed in regulation 
     promulgated by the Secretary, but nothing in this clause 
     shall be deemed to require that any trade secret be divulged: 
     Provided, That the requirements of this clause with respect 
     to alphabetical order shall apply only to nonprescription 
     drugs that are not also cosmetics: and Provided further, That 
     this clause shall not apply to nonprescription drugs not 
     intended for human use.
       ``(B) For any prescription drug the established name of 
     such drug or ingredient, as the case may be, on such label 
     (and on any labeling on which a name for such drug or 
     ingredient is used) shall be printed prominently and in type 
     at least half as large as that used thereon for any 
     proprietary name or designation for such drug or ingredient: 
     Provided, That to the extent that compliance with the 
     requirements of clause (A)(ii) or (iii) or this clause of 
     this subparagraph is impracticable, exemptions shall be 
     established by regulations promulgated by the Secretary.''.

[[Page S9864]]

       (d) Cosmetics.--Subchapter F of chapter VII, as amended by 
     subsection (a), is further amended by adding at the end the 
     following:

     ``SEC. 762. PREEMPTION FOR LABELING OR PACKAGING OF 
                   COSMETICS.

       ``(a) In General.--Except as provided in subsection (b), 
     (d), or (e), a State or political subdivision of a State 
     shall not impose or continue in effect any requirement for 
     labeling or packaging of a cosmetic that is different from or 
     in addition to, or that is otherwise not identical with a 
     requirement specifically applicable to a particular cosmetic 
     or class of cosmetics under this Act, the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair 
     Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
       ``(b) Exemption.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement for labeling and packaging that--
       ``(1) protects an important public interest that would 
     otherwise be unprotected;
       ``(2) would not cause a cosmetic to be in violation of any 
     applicable requirements or prohibition under Federal law; and
       ``(3) would not unduly burden interstate commerce.
       ``(c) Scope.--For purposes of subsection (a), a reference 
     to a State requirement that relates to the packaging or 
     labeling of a cosmetic means any specific requirement 
     relating to the same aspect of such cosmetic as a requirement 
     specifically applicable to that particular cosmetic or class 
     of cosmetics under this Act for packaging or labeling, 
     including any State requirement relating to public 
     information or any other form of public communication.
       ``(d) No Effect on Product Liability Law.--Nothing in this 
     section shall be construed to modify or otherwise affect any 
     action or the liability of any person under the product 
     liability law of any State.
       ``(e) State Initiative.--This section shall not apply to a 
     State requirement adopted by a State public initiative or 
     referendum enacted prior to September 1, 1997.''.

     SEC. 808. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS 
                   OR LIFE-THREATENING DISEASES.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282) is amended--
       (1) by redesignating subsections (j) and (k) as subsections 
     (k) and (l), respectively; and
       (2) by inserting after subsection (i), the following:
       ``(j)(1) The Secretary, acting through the Director of the 
     National Institutes of Health and subject to the availability 
     of appropriations, shall establish, maintain, and operate a 
     program with respect to information on research relating to 
     the treatment, detection, and prevention of serious or life-
     threatening diseases and conditions. The program shall, with 
     respect to the agencies of the Department of Health and Human 
     Services, be integrated and coordinated, and, to the extent 
     practicable, coordinated with other data banks containing 
     similar information.
       ``(2)(A) After consultation with the Commissioner of Food 
     and Drugs, the directors of the appropriate agencies of the 
     National Institutes of Health (including the National Library 
     of Medicine), and the Director of the Centers for Disease 
     Control and Prevention, the Secretary shall, in carrying out 
     paragraph (1), establish a data bank of information on 
     clinical trials for drugs, and biologicals, for serious or 
     life-threatening diseases and conditions.
       ``(B) In carrying out subparagraph (A), the Secretary shall 
     collect, catalog, store, and disseminate the information 
     described in such subparagraph. The Secretary shall 
     disseminate such information through information systems, 
     which shall include toll-free telephone communications, 
     available to individuals with serious or life-threatening 
     diseases and conditions, to other members of the public, to 
     health care providers, and to researchers.
       ``(3) The data bank shall include the following:
       ``(A) A registry of clinical trials (whether federally or 
     privately funded) of experimental treatments for serious or 
     life-threatening diseases and conditions under regulations 
     promulgated pursuant to sections 505 and 520 of the Federal 
     Food, Drug, and Cosmetic Act that provides a description of 
     the purpose of each experimental drug or biological protocol, 
     either with the consent of the protocol sponsor, or when a 
     trial to test efficacy begins. Information provided shall 
     consist of eligibility criteria, a description of the 
     location of trial sites, and a point of contact for those 
     wanting to enroll in the trial, and shall be in a form that 
     can be readily understood by members of the public. Such 
     information must be forwarded to the data bank by the sponsor 
     of the trial not later than 21 days after the approval by the 
     Food and Drug Administration.
       ``(B) Information pertaining to experimental treatments for 
     serious or life-threatening diseases and conditions that may 
     be available--
       ``(i) under a treatment investigational new drug 
     application that has been submitted to the Food and Drug 
     Administration pursuant to part 312 of title 21, Code of 
     Federal Regulations; or
       ``(ii) as a Group C cancer drug.

     The data bank may also include information pertaining to the 
     results of clinical trials of such treatments, with the 
     consent of the sponsor, including information concerning 
     potential toxicities or adverse effects associated with the 
     use or administration of such experimental treatments.
       ``(4) The data bank shall not include information relating 
     to an investigation if the sponsor has provided a detailed 
     certification to the Secretary that disclosure of such 
     information would substantially interfere with the timely 
     enrollment of subjects in the investigation, unless the 
     Secretary, after the receipt of the certification, provides 
     the sponsor with a detailed written determination that finds 
     that such disclosure would not substantially interfere with 
     such enrollment.
       ``(5) For the purpose of carrying out this subsection, 
     there are authorized to be appropriated such sums as may be 
     necessary. Fees collected under section 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h) shall not be 
     authorized or appropriated for use in carrying out this 
     subsection.''.
       (b) Collaboration and Report.--
       (1) In general.--The Secretary of Health and Human 
     Services, the Director of the National Institutes of Health, 
     and the Commissioner of Food and Drugs shall collaborate to 
     determine the feasibility of including device investigations 
     within the scope of the registry requirements set forth in 
     subsection (j) of section 402 of the Public Health Service 
     Act.
       (2) Report.--Not later than 2 years after the date of 
     enactment of this section, the Secretary of Health and Human 
     Services shall prepare and submit to the Committee on Labor 
     and Human Resources of the Senate and the Committee on 
     Commerce of the House of Representatives a report that shall 
     consider, among other things--
       (A) the public health need, if any, for inclusion of device 
     investigations within the scope of the registry requirements 
     set forth in subsection (j) of section 402 of the Public 
     Health Service Act; and
       (B) the adverse impact, if any, on device innovation and 
     research in the United States if information relating to such 
     device investigation is required to be publicly disclosed.

     SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF 
                   PHARMACY COMPOUNDING.

       Section 503 (21 U.S.C. 353) is amended by adding at the end 
     the following:
       ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 
     507 shall not apply to a drug product if--
       ``(A) the drug product is compounded for an identified 
     individual patient, based on a medical need for a compounded 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, on the 
     prescription order of a licensed physician or other licensed 
     practitioner authorized by State law to prescribe drugs; or
       ``(ii) by a licensed pharmacist or licensed physician in 
     limited quantities, prior to the receipt of a valid 
     prescription order for the identified individual patient, and 
     is compounded based on a history of the licensed pharmacist 
     or licensed physician receiving valid prescription orders for 
     the compounding of the drug product that have been generated 
     solely within an established relationship between the 
     licensed pharmacist, or licensed physician, and--
       ``(I) the individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order; and
       ``(B) the licensed pharmacist or licensed physician--
       ``(i) compounds the drug product using bulk drug 
     substances--
       ``(I) that--

       ``(aa) comply with the standards of an applicable United 
     States Pharmacopeia or National Formulary monograph; or
       ``(bb) in a case in which such a monograph does not exist, 
     are drug substances that are covered by regulations issued by 
     the Secretary under paragraph (3);

       ``(II) that are manufactured by an establishment that is 
     registered under section 510 (including a foreign 
     establishment that is registered under section 510(i)); and
       ``(III) that are accompanied by valid certificates of 
     analysis for each bulk drug substance;
       ``(ii) compounds the drug product using ingredients (other 
     than bulk drug substances) that comply with the standards of 
     an applicable United States Pharmacopeia or National 
     Formulary monograph and the United States Pharmacopeia 
     chapter on pharmacy compounding;
       ``(iii) only advertises or promotes the compounding service 
     provided by the licensed pharmacist or licensed physician and 
     does not advertise or promote the compounding of any 
     particular drug, class of drug, or type of drug;
       ``(iv) does not compound a drug product that appears on a 
     list published by the Secretary in the Federal Register of 
     drug products that have been withdrawn or removed from the 
     market because such drug products or components of such drug 
     products have been found to be unsafe or not effective;
       ``(v) does not compound a drug product that is identified 
     by the Secretary in regulation as presenting demonstrable 
     difficulties for compounding that reasonably demonstrate an 
     adverse effect on the safety or effectiveness of that drug 
     product; and
       ``(vi) does not distribute compounded drugs outside of the 
     State in which the drugs are compounded, unless the principal 
     State

[[Page S9865]]

     agency of jurisdiction that regulates the practice of 
     pharmacy in such State has entered into a memorandum of 
     understanding with the Secretary regarding the regulation of 
     drugs that are compounded in the State and are distributed 
     outside of the State, that provides for appropriate 
     investigation by the State agency of complaints relating to 
     compounded products distributed outside of the State.
       ``(2)(A) The Secretary shall, after consultation with the 
     National Association of Boards of Pharmacy, develop a 
     standard memorandum of understanding for use by States in 
     complying with paragraph (1)(B)(vi).
       ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed 
     pharmacist or licensed physician, who does not distribute 
     inordinate amounts of compounded products outside of the 
     State, until--
       ``(i) the date that is 180 days after the development of 
     the standard memorandum of understanding; or
       ``(ii) the date on which the State agency enters into a 
     memorandum of understanding under paragraph (1)(B)(vi),

     whichever occurs first.
       ``(3) The Secretary, after consultation with the United 
     States Pharmacopeia Convention Incorporated, shall promulgate 
     regulations limiting compounding under paragraph 
     (1)(B)(i)(I)(bb) to drug substances that are components of 
     drug products approved by the Secretary and to other drug 
     substances as the Secretary may identify.
       ``(4) The provisions of paragraph (1) shall not apply--
       ``(A) to compounded positron emission tomography drugs as 
     defined in section 201(ii); or
       ``(B) to radiopharmaceuticals.
       ``(5) In this subsection, the term `compound' does not 
     include to mix, reconstitute, or perform another similar act, 
     in accordance with directions contained in approved drug 
     labeling provided by a drug manufacturer and other drug 
     manufacturer directions consistent with that labeling.''.

     SEC. 810. REPORTS OF POSTMARKETING APPROVAL STUDIES.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
     amended by section 613(a), is further amended by adding at 
     the end the following:

     ``SEC. 562. REPORTS OF POSTMARKETING STUDIES.

       ``(a) Submission.--
       ``(1) In general.--A sponsor of a drug that has entered 
     into an agreement with the Secretary to conduct a 
     postmarketing study of a drug shall submit to the Secretary, 
     within 1 year after the approval of such drug and annually 
     thereafter until the study is completed or terminated, a 
     report of the progress of the study or the reasons for the 
     failure of the sponsor to conduct the study. The report shall 
     be submitted in such form as prescribed by the Secretary in 
     regulations issued by the Secretary.
       ``(2) Agreements prior to effective date.--An agreement 
     entered into between the Secretary and a sponsor of a drug, 
     prior to the date of enactment of this section, to conduct a 
     postmarketing study of a drug shall be subject to the 
     requirements of paragraph (1). An initial report for such an 
     agreement shall be submitted within 6 months after the date 
     of the issuance of the regulations under paragraph (1).
       ``(b) Consideration of Information as Public Information.--
     Any information pertaining to a report described in paragraph 
     (1) shall be considered to be public information to the 
     extent that the information is necessary--
       ``(1) to identify the sponsor; and
       ``(2) to establish the status of a study described in 
     subsection (a) and the reasons, if any, for any failure to 
     carry out the study.
       ``(c) Status of Studies and Reports.--The Secretary shall 
     annually develop and publish in the Federal Register a report 
     that provides a status of the postmarketing studies--
       ``(1) that sponsors have entered into agreements to 
     conduct; and
       ``(2) for which reports have been submitted under 
     subsection (a)(1).''.
       (b) Report to Congressional Committees.--Not later than 
     October 1, 2001, the Secretary shall prepare and submit to 
     the Committee on Labor and Human Resources of the Senate and 
     the Committee on Commerce of the House of Representatives a 
     report containing--
       (1) a summary of the reports submitted under section 562 of 
     the Federal Food, Drug, and Cosmetic Act; and
       (2) an evaluation of--
       (A) the performance of the sponsors in fulfilling the 
     agreements with respect to the conduct of postmarketing 
     studies described in such section of such Act;
       (B) the timeliness of the Secretary's review of the 
     postmarketing studies; and
       (C) any legislative recommendations respecting 
     postmarketing studies.

      SEC. 811. INFORMATION EXCHANGE.

       (a) In General.--Chapter VII (2 U.S.C. 371 et seq.), as 
     amended by section 807, is further amended by adding at the 
     end the following:

        ``Subchapter G--Dissemination of Treatment Information 

     ``SEC. 771. DISSEMINATION OF TREATMENT INFORMATION ON DRUGS, 
                   BIOLOGICAL PRODUCTS, AND DEVICES.

       ``(a) Dissemination of Treatment Information.--
       ``(1) In general.--Notwithstanding sections 301(d), 502(f), 
     505, and 507 and section 351 of the Public Health Service Act 
     (42 U.S.C. 262), and subject to the requirements of 
     paragraphs (2) through (6) and subsection (b), a manufacturer 
     may disseminate to a health care practitioner, a pharmacy 
     benefit manager, a health maintenance organization or other 
     managed health care organization, or a health care insurer or 
     governmental agency, written information concerning the 
     safety, effectiveness, or benefit (whether or not such 
     information is contained in the official labeling) of a drug, 
     biological product, or device for which--
       ``(A) an approval of an application filed under section 
     505(b), 505(j), or 515, a clearance in accordance with 
     section 510(k), an approval in accordance with section 507, 
     or a biologics license issued under section 351 of the Public 
     Health Service Act, is in effect; and
       ``(B) if the use is not described in the approved labeling 
     of the product, the manufacturer has submitted to the 
     Secretary a certification that a supplemental application for 
     that use will be submitted to the Secretary pursuant to 
     paragraph (3) or the manufacturer has received an exemption 
     under paragraph (3)(C).
       ``(2) Authorized information.--A manufacturer may 
     disseminate the written information under paragraph (1) only 
     if the information--
       ``(A) is in the form of an unabridged--
       ``(i) reprint or copy of a peer-reviewed article from a 
     scientific or medical journal (as defined in subsection 
     (c)(5)) of a clinical investigation, with respect to a drug, 
     biological product or device, that would be considered to be 
     scientifically sound by experts qualified by scientific 
     training or experience to evaluate the safety or 
     effectiveness of the drug, biological product, or device that 
     is the subject of such clinical investigation; or
       ``(ii) reference textbook (as defined in subsection (c)(4)) 
     that includes information about a clinical investigation with 
     respect to a drug, biological product, or device, that would 
     be considered to be scientifically sound by experts qualified 
     by scientific training or experience to evaluate the safety 
     or effectiveness of the drug, biological product, or device 
     that is the subject of such clinical investigation; and
       ``(B) is not false, not misleading, and would not pose a 
     significant risk to the public health.
       ``(3) Commitment to file a supplemental application; 
     incentives for research.--
       ``(A) In general.--A manufacturer may disseminate 
     information about a use not described in the approved 
     labeling of a drug, biological product, or device pursuant to 
     paragraph (1) only if--
       ``(i) the manufacturer has submitted to the Secretary a 
     certification that the studies needed to file a supplemental 
     application for such use have been completed and such 
     supplement will be filed within 6 months after the date of 
     the initial dissemination of information under paragraph (1); 
     or
       ``(ii)(I) the manufacturer has submitted to the Secretary a 
     proposed protocol and schedule for conducting the studies 
     needed to submit a supplemental application for such use and 
     has certified that the supplement will be submitted within 36 
     months after the date of the initial dissemination of 
     information under paragraph (1); and
       ``(II) the Secretary has determined that the protocol for 
     conducting such studies is adequate and that the schedule for 
     completing such studies is reasonable.
       ``(B) Extension.--
       ``(i) Longer period of time.--The Secretary may grant a 
     longer period of time for a manufacturer to submit a 
     supplemental application pursuant to subparagraph (A) if the 
     Secretary determines that the studies needed to submit a 
     supplemental application cannot be completed and submitted 
     within 36 months.
       ``(ii) Extension of 3-year period.--The Secretary may 
     extend the time within which a manufacturer must submit a 
     supplemental application pursuant to subparagraph (A) if the 
     manufacturer demonstrates that the manufacturer has acted 
     with due diligence to conduct the studies in a timely manner. 
     Such extension shall not exceed a period of 24 months.
       ``(C) Exemptions.--A manufacturer may file a request for an 
     exemption from the requirements set forth in subparagraph 
     (A). Such request shall be submitted in the form and manner 
     prescribed by the Secretary and shall demonstrate that--
       ``(i) due to the size of the patient population or the lack 
     of potential benefit to the sponsor, the cost of obtaining 
     clinical information and submitting a supplemental 
     application is economically prohibitive; or
       ``(ii) it would be unethical to conduct the studies 
     necessary to obtain adequate evidence for approval of a 
     supplemental application.

     The Secretary shall act on a request for an exemption under 
     this subparagraph within 60 days after the receipt of the 
     request. If the Secretary fails to act within 60 days, the 
     manufacturer may begin to disseminate information pursuant to 
     paragraph (1) without complying with subparagraph (A). If the 
     Secretary subsequently denies the request for an exemption, 
     the manufacturer either shall cease dissemination or shall 
     comply with the requirements of subparagraph (A) within 60 
     days after such denial. If the manufacturer ceases 
     dissemination pursuant to this subparagraph solely on the 
     basis that the manufacturer does not comply with subparagraph 
     (A), the Secretary may take appropriate corrective action, 
     but may not order the manufacturer to take corrective action.
       ``(D) Report.--A manufacturer who submits a certification 
     to the Secretary under

[[Page S9866]]

     subparagraph (A) shall provide the Secretary periodic reports 
     that describe the status of the studies being conducted to 
     obtain adequate evidence for approval of a supplemental 
     application.
       ``(4) Information on new uses.--
       ``(A) In general.--If the information being disseminated 
     under paragraph (1) meets the requirements of this section, a 
     manufacturer may disseminate information under paragraph (1) 
     concerning the new use of a drug, biological product, or 
     device (described in paragraph (1)) 60 calendar days after 
     the manufacturer has submitted to the Secretary--
       ``(i) a copy of the information; and
       ``(ii) any clinical trial information the manufacturer has 
     relating to the safety or efficacy of the new use, any 
     reports of clinical experience pertinent to the safety of the 
     new use, and a summary of such information.

     If any of the information required to be provided under 
     clause (ii) has already been provided to the Secretary, the 
     manufacturer may meet the requirements of clause (ii) by 
     providing any such information obtained by the manufacturer 
     since the manufacturer's last submission to the Secretary and 
     a summary that identifies the information previously 
     provided.
       ``(B) Additional information.--If the Secretary determines 
     that the information submitted by a manufacturer under 
     subparagraph (A)(i) with respect to a new use of a drug, 
     biological product, or device fails to provide data, 
     analyses, or other written matter, that is objective and 
     balanced, the Secretary may require the manufacturer to 
     disseminate along with the information described in 
     subparagraph (A)--
       ``(i) additional information with respect to the new use of 
     the drug, biological product, or device that--

       ``(I) is in the form of an article described in paragraph 
     (2)(A); and
       ``(II) provides data, analyses, or other written matter, 
     that is scientifically sound;

       ``(ii) additional objective and scientifically sound 
     information that pertains to the safety or efficacy of the 
     use and is necessary to provide objectivity and balance, 
     including any information that the manufacturer has submitted 
     to the Secretary, or where appropriate, a summary of such 
     information, or any other information that the Secretary has 
     authority to make available to the public;
       ``(iii) an objective statement prescribed by the Secretary 
     based on information described in clause (i) or (ii), 
     provided the manufacturer has access to the data that forms 
     the basis of such statement unless the Secretary is 
     prohibited from making such data available to the 
     manufacturer; and
       ``(iv) a statement that describes any previous public 
     announcements by the Secretary relevant to the new use.
       ``(5) New information.--If a manufacturer that is 
     disseminating information pursuant to paragraph (1) becomes 
     aware of new information relating to the safety or efficacy 
     of a new use of a drug, biological product, or device for 
     which information was disseminated under paragraph (1), the 
     manufacturer shall notify the Secretary with respect to the 
     new information. If the Secretary determines that the new 
     information demonstrates that a drug, biological product, or 
     device may not be effective or may present a significant risk 
     to public health, the Secretary shall, in consultation with 
     the manufacturer, take such appropriate action as the 
     Secretary determines necessary to ensure public health and 
     safety. The Secretary may limit the types of new information 
     that must be submitted under this paragraph.
       ``(6) Cessation of dissemination; corrective action.--The 
     Secretary may order a manufacturer to cease the dissemination 
     of all information being disseminated pursuant to paragraph 
     (1) if--
       ``(A) the Secretary finds that a supplemental application 
     does not contain adequate information for approval for the 
     use that is the subject of the information;
       ``(B) the Secretary determines, after an informal hearing, 
     that the manufacturer is not acting with due diligence to 
     complete the studies necessary to file a supplemental 
     application for the use that is the subject of the 
     information being disseminated; or
       ``(C) the Secretary determines that the information being 
     disseminated does not comply with the requirements set forth 
     in this section, after providing notice, an opportunity for a 
     meeting, and for minor violations of this section (if there 
     has been substantial compliance with this section), an 
     opportunity to correct such information.

     If the Secretary orders cessation of dissemination pursuant 
     to this paragraph, the Secretary may order the manufacturer 
     to take appropriate corrective action.
       ``(7) Sponsored research.--If a manufacturer has sponsored 
     research that results in information as described in 
     paragraph (2)(A), another manufacturer may not distribute the 
     information under this section, unless such manufacturer is 
     required by the Secretary to distribute the information.
       ``(b) Disclosure Statement.--In order to afford a full and 
     fair evaluation of the information described in subsection 
     (a), a manufacturer disseminating the information shall 
     include along with the information--
       ``(1) a prominently displayed statement that discloses--
       ``(A) that the information concerns a use of a drug, 
     biological product, or device or other attribute of a drug, 
     biological product, or device that has not been approved by 
     the Food and Drug Administration;
       ``(B) if applicable, that the information is being 
     disseminated at the expense of the manufacturer;
       ``(C) if applicable, the name of any authors of the 
     information who are employees of, or consultants to, or have 
     received compensation from, the manufacturer, or who have a 
     significant financial interest in the manufacturer;
       ``(D) the official labeling for the drug, biological 
     product, or device and all updates with respect to the 
     labeling;
       ``(E) if applicable, a statement that there are products or 
     treatments that have been approved for the use that is the 
     subject of the information being disseminated pursuant to 
     subsection (a)(1); and
       ``(F) the identification of any person that has provided 
     funding for the conduct of a study relating to a new use of a 
     drug, biological product, or device for which such 
     information is being disseminated; and
       ``(2) a bibliography of other articles from a scientific 
     reference textbook or scientific or medical journal that have 
     been previously published about the new use of a drug, 
     biological product, or device covered by the information 
     disseminated (unless the information already includes such 
     bibliography).
       ``(c) Definitions.--As used in this section:
       ``(1) Health care practitioner.--The term `health care 
     practitioner' means a medical provider that is licensed to 
     prescribe a drug or biological product, or to prescribe or 
     use a device, for the treatment of a disease or other medical 
     condition.
       ``(2) Manufacturer.--The term `manufacturer' includes a 
     person who manufactures, distributes, or markets a drug, 
     biological product, or device.
       ``(3) New use.--The term `new use' used with respect to a 
     drug, biological product, or device means a use of a drug, 
     biological product, or device not included in the approved 
     labeling of such drug, biological product, or device.
       ``(4) Reference textbook.--The term `reference textbook' 
     means a reference publication that--
       ``(A) has not been written, edited, excerpted, or published 
     specifically for, or at the request of a manufacturer of a 
     drug, biological product, or device;
       ``(B) has not been edited or significantly influenced by a 
     manufacturer of a drug, biological product, or device;
       ``(C) is not solely distributed through a manufacturer of a 
     drug, biological product, or device but is generally 
     available in bookstores or other distribution channels where 
     medical textbooks are sold;
       ``(D) does not focus on any particular drug, biological 
     product, or device of a manufacturer that disseminates 
     information under subsection (a), and does not have a primary 
     focus on new uses of drugs, biological products, or devices 
     that are marketed or under investigation by a manufacturer 
     supporting the dissemination of information; and
       ``(E) presents materials that are not false or misleading.
       ``(5) Scientific or medical journal.--The term `scientific 
     or medical journal' means a scientific or medical 
     publication--
       ``(A) that is published by an organization--
       ``(i) that has an editorial board;
       ``(ii) that utilizes experts, who have demonstrated 
     expertise in the subject of an article under review by the 
     organization and who are independent of the organization, to 
     review and objectively select, reject, or provide comments 
     about proposed articles; and
       ``(iii) that has a publicly stated policy, to which the 
     organization adheres, of full disclosure of any conflict of 
     interest or biases for all authors or contributors involved 
     with the journal or organization;
       ``(B) whose articles are peer-reviewed and published in 
     accordance with the regular peer-review procedures of the 
     organization;
       ``(C) that is generally recognized to be of national scope 
     and reputation;
       ``(D) that is indexed in the Index Medicus of the National 
     Library of Medicine of the National Institutes of Health;
       ``(E) that presents materials that are not false or 
     misleading; and
       ``(F) that is not in the form of a special supplement that 
     has been funded in whole or in part by 1 or more 
     manufacturers.
       ``(d) Construction.--Nothing in this section shall be 
     construed as prohibiting a manufacturer from disseminating 
     information in response to an unsolicited request from a 
     health care practitioner.
       ``(e) Studies and Reports.--
       ``(1) General accounting office.--
       ``(A) In general.--The Comptroller General of the United 
     States shall conduct a study to determine the impact of this 
     section on the resources of the Department of Health and 
     Human Services.
       ``(B) Report.--Not later than January 1, 2002, the 
     Comptroller General of the United States shall prepare and 
     submit to the Committee on Labor and Human Resources of the 
     Senate and the Committee on Commerce of the House of 
     Representatives a report of the results of the study.
       ``(2) Department of health and human services.--
       ``(A) In general.--In order to assist Congress in 
     determining whether the provisions of this section should be 
     extended beyond the termination date specified in section 
     811(e) of the Food and Drug Administration Modernization and 
     Accountability Act of 1997, the Secretary of Health and Human 
     Services shall, in accordance with subparagraph (B),

[[Page S9867]]

     arrange for the conduct of a study of the scientific issues 
     raised as a result of the enactment of this section, 
     including issues relating to--
       ``(i) the effectiveness of this section with respect to the 
     provision of useful scientific information to health care 
     practitioners;
       ``(ii) the quality of the information being disseminated 
     pursuant to the provisions of this section;
       ``(iii) the quality and usefulness of the information 
     provided, in accordance with this section, by the Secretary 
     or by the manufacturer at the request of the Secretary; and
       ``(iv) the impact of this section on research in the area 
     of new uses, indications, or dosages, particularly the impact 
     on pediatric indications and rare diseases.
       ``(3) Procedure for study.--
       ``(A) In general.--The Secretary shall request the 
     Institute of Medicine of the National Academy of Sciences to 
     conduct the study required by paragraph (2), and to prepare 
     and submit the report required by subparagraph (B), under an 
     arrangement by which the actual expenses incurred by the 
     Institute of Medicine in conducting the study and preparing 
     the report will be paid by the Secretary. If the Institute of 
     Medicine is unwilling to conduct the study under such an 
     arrangement, the Secretary shall enter into a similar 
     arrangement with another appropriate nonprofit private group 
     or association under which the group or association will 
     conduct the study and prepare and submit the report.
       ``(B) Report.--Not later than September 30, 2005, the 
     Institute of Medicine, the group, or association, as 
     appropriate, shall prepare and submit to the Committee on 
     Labor and Human Resources of the Senate, the Committee on 
     Commerce of the House of Representatives, and the Secretary a 
     report of the results of the study required by paragraph (2). 
     The Secretary, after the receipt of the report, shall make 
     the report available to the public.
       ``(4) Authorization of appropriation.--There are authorized 
     to be appropriated such sums as are necessary to carry out 
     this subsection.

     ``SEC. 772. ESTABLISHMENT OF LIST OF ARTICLES AND TEXTBOOKS 
                   DISSEMINATED AND LIST OF PROVIDERS THAT 
                   RECEIVED ARTICLES AND REFERENCE TEXTBOOKS.

       ``(a) In General.--A manufacturer that disseminates 
     information in the form of articles or reference textbooks 
     under section 771 shall prepare and submit to the Secretary 
     biannually--
       ``(1) a list containing the titles of the articles and 
     reference textbooks relating to the new use of drugs, 
     biological products, and devices that were disseminated by 
     the manufacturer to a person described in section 771(a)(1) 
     for the 6-month period preceding the date on which the 
     manufacturer submits the list to the Secretary; and
       ``(2) a list that identifies the categories of providers 
     (as described in section 771(a)(1)) that received the 
     articles and reference textbooks for the 6-month period 
     described in paragraph (1).
       ``(b) Records.--A manufacturer that disseminates 
     information under section 771 shall keep records that 
     identify the recipients of articles and textbooks provided 
     pursuant to section 771. Such records are to be used by the 
     manufacturer when, pursuant to section 771(a)(6), such 
     manufacturer is required to take corrective action and shall 
     be made available to the Secretary, upon request, for 
     purposes of ensuring or taking corrective action pursuant to 
     paragraph (3), (5), or (6) of section 771(a).

     ``SEC. 773. CONSTRUCTION.

       ``(a) Dissemination of Information on Drugs or Devices Not 
     Evidence of Intended Use.--Notwithstanding subsection (a), 
     (f), or (o) of section 502, or any other provision of law, 
     the dissemination of information relating to a new use of a 
     drug or device, in accordance with section 771, shall not be 
     construed by the Secretary as evidence of a new intended use 
     of the drug or device that is different from the intended use 
     of the drug or device set forth in the official labeling of 
     the drug or device. Such dissemination shall not be 
     considered by the Secretary as labeling, adulteration, or 
     misbranding of the drug or device.
       ``(b) Patent Protection.--Nothing in section 771 shall 
     affect patent rights in any manner.
       ``(c) Authorization for Dissemination of Articles and Fees 
     for Reprints of Articles.--Nothing in section 771 shall be 
     construed as prohibiting an entity that publishes a 
     scientific journal (as defined in section 771(c)(5)) from 
     requiring authorization from the entity to disseminate an 
     article published by such entity and from charging fees for 
     the purchase of reprints of published articles from such 
     entity.''.
       (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by section 205(b), is further amended by adding at 
     the end the following:
       ``(y) The dissemination of information pursuant to section 
     771 by a manufacturer who fails to comply with the 
     requirements of such section.''.
       (c) Regulations.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate regulations to implement the 
     amendments made by this section.
       (d) Effective Date.--The amendments made by this section 
     shall take effect 1 year after the date of enactment of this 
     Act, or upon the Secretary's issuance of final regulations 
     pursuant to subsection (c), whichever is sooner.
       (e) Termination of Effectiveness.--The amendments made by 
     this section cease to be effective September 30, 2006, or 7 
     years after the date on which the Secretary promulgates the 
     regulations described in subsection (c), whichever is later.

     SEC. 812. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

       Section 2 of Public Law 102-222 (105 Stat. 1677) is 
     amended--
       (1) in subsection (a), by striking ``a grant'' and all that 
     follows through ``Such grant'' and inserting the following: 
     ``grants for a pilot program for the training of individuals 
     in clinical pharmacology at appropriate medical schools. Such 
     grants''; and
       (2) in subsection (b), by striking ``to carry out this 
     section'' and inserting ``, and for fiscal years 1998 through 
     2002 $3,000,000 for each fiscal year, to carry out this 
     section''.

     SEC. 813. MONOGRAPH FOR SUNBURN PRODUCTS.

       Not later than 18 months after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue a final monograph for over-the-counter sunburn products 
     for prevention or treatment of sunburn.

     SEC. 814. SAFETY REPORT DISCLAIMERS.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     804, is further amended by adding at the end the following:

     ``SEC. 908. SAFETY REPORT DISCLAIMERS.

       ``With respect to any entity that submits or is required to 
     submit a safety report or other information in connection 
     with the safety of a product (including a product which is a 
     food, drug, new drug, device, dietary supplement, or 
     cosmetic) under this Act (and any release by the Secretary of 
     that report or information), such report or information shall 
     not be construed to necessarily reflect a conclusion by the 
     entity or the Secretary that the report or information 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience, or otherwise caused or 
     contributed to a death, serious injury, serious illness, or 
     malfunction. Such an entity need not admit, and may deny, 
     that the report or information submitted by the entity 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience or caused or contributed 
     to a death, serious injury, serious illness, or 
     malfunction.''.

  Mr. JEFFORDS. Mr. President, I move to reconsider the vote.
  Mr. COATS. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  Mr. JEFFORDS. Mr. President, I thank my colleagues and I thank them 
profusely for their vote, for their support in the committee, and all 
the work that has gone into this. But, as we all know, there are people 
who work behind the scenes, those who are probably more responsible for 
this vote than we on the floor are. I just want to take a moment to 
thank the staff.
  In the office of Senate Legislative Counsel, Robin Bates, Elizabeth 
Aldridge, and Bill Baird worked tirelessly to produce countless bill 
drafts and amendments. And how they came out with them as expeditiously 
as they did, I'm not sure.
  The staff at CRS, especially Donna Vogt, and at GAO, including 
Bernice Steinhardt deserve thanks for their willingness to provide 
essential information and documents on extremely short notice. We must 
always remember to appreciate these organizations that provide so much 
assistance to the Congress.
  The staff to the members of the committee contributed greatly to the 
success of this bill. In particular, Vince Ventimiglia with Senator 
Coats' staff worked closely with ours in a true partnership on all 
aspects of S. 830.
  In addition, Kimberly Spaulding with Senator Gregg, Sue Ramthun with 
Senator Frist, Saira Sultan with Senator DeWine, and Kate Lambrew-Hull 
with Senator Hutchinson all played important roles in fashioning 
compromises on key provisions of this bill. Also, Mark Smith with 
Senator Mack's staff worked very hard to make the agreement on off-
label dissemination of information possible.
  I would also like to thank the many staff of the administration who 
have worked on this legislation.
  In particular, I want to thank Bill Schultz, Diane Thompson, and 
Peggy Dotzel, of the FDA.
  Similarly, three staffers for members of the minority on the 
committee played pivotal roles even before committee markup took place 
in making this bill a bipartisan success.
  Lynne Lawrence with Senator Mikulski deserves special mention in 
recognition of her hard work in the last Congress on FDA reform and her 
willingness to put her future career plans

[[Page S9868]]

on hold to commit herself again to the long hard job of bringing this 
bill to the floor this year. Jeanne Ireland with Senator Dodd and Linda 
DeGutis, a fellow with Senator Wellstone also provided invaluable 
assistance.
  Of course I would like to thank the Labor and Human Resources 
Committee majority and minority staffs who did the most work on this. 
In particular, I want to recognize Susan Hattan who stayed on with the 
committee after Senator Kassebaum's retirement.
  She, and another Senator Kassebaum staffer, Jane Williams, who is now 
on the staff of Representative Fred Upton, worked long hours last year 
to put FDA reform on the Senate agenda and brought a bill to successful 
committee markup in the last Congress--we stand here today in large 
part due to their hard work.
  On the minority staff, I would like to thank Nick Littlefield and 
David Nexon and two minority fellows Diane Robertson and Debbie 
Kochever. Finally, I would like to thank the majority staff director 
Mark Powden, Jay Hawkins, and majority fellow Sean Donohue.
  I want to take a moment to elaborate on my comments regarding one of 
the majority staff who has worked so diligently on this measure--Jay 
Hawkins. Jay joined my staff in January--literally hit the ground 
running--and I don't think he has stopped moving since.
  He has set a new standard of dedication for professional staff to 
find the best solution in a difficult and controversial policy arena. 
He has been saluted by other Senators' staffs, from both majority and 
minority offices, for his willingness to include them in all aspects of 
this effort.
  Mr. President, part of the job description for Senate staff is to 
take abuse. Jay unfortunately received more than his share, but it said 
more about his critics than him.
  More recently--a little more than a month ago--Jay lost his mother to 
her 4-year battle with cancer. My friend, Senator Hatch, acknowledged 
on the floor just yesterday this hardship Jay faced and was eloquent in 
his praise for both Jay and for his mother--Donna Lotz Hawkins. Mrs. 
Hawkins was not unfamiliar with challenge and adversity. She was an 
experienced mountain climber and conquered some of the world's most 
difficult mountains in the Alaska range, the Tetons, the Alps, and the 
Himalayas. She was a dedicated ocean swimmer and conquered the white 
waters in Waikiki and Maui.
  It is clear to us who know Jay that he too has the spirit of taking 
on the task when faced with adversity and challenge. We know the source 
of that sense of commitment and we cannot thank him enough for his 
efforts on this bill.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, in typical fashion, Senator Jeffords has 
given great credit where credit is due, and as I mentioned just before, 
the chairman of our committee really deserves credit for the passage of 
this very important bill. I commend him.
  If I could, I will just take a moment of the Senate's time, but I 
think it is important to mention on our side David Nexon and Diane 
Robertson, who worked so closely with us; Jim Manly, Debbie Kochevar, 
Meg Archdeacon, Burt Cowgill, Susan Hammersten, Jonathan Halperin, and 
Danielle Drissel, Carrie Coberly and Addy Schmidt; Bonnie Hogue on 
Senator Reed's staff and Deborah Walker on Senator Bingaman's staff; 
Sabrina Corlette with Senator Harkin and Anne-Marie Murphy with Senator 
Durbin.
  I would like to believe the staffs have been helpful to all of us and 
don't work so much in a partisan way as in a common spirit, to try to 
advance the common interests. That has been, certainly, true on this 
legislation.
  I thank all of those, and the majority staff as well, for all of 
their courtesies and for their cooperation. I think the record ought to 
show the dedication of, really, an outstanding group of men and women 
who have really served the Senate very, very well. I thank the 
chairman.
  Mr. JEFFORDS. Mr. President, I thank the ranking minority member on 
my committee for his words. I commend him, also. We disagreed rather 
strongly on one issue here, but 19 out of 20 we were together and 
worked together, and certainly that's a pretty good average.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. FAIRCLOTH. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________