[Federal Register Volume 66, Number 65 (Wednesday, April 4, 2001)]
[Notices]
[Pages 17912-17914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-1852]


Draft ``Guidance for Industry: Reports on the Status of 
Postmarketing Studies--Implementation of Section 130 of the Food and 
Drug Administration Modernization Act of 1997;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Reports on the Status of Postmarketing Studies--Implementation of 
Section 130 of the Food and Drug Administration Modernization Act of 
1997.'' This draft guidance provides recommendations on procedures, 
content, and format for submitting a postmarketing study status report 
for an approved human drug or licensed biological product; timeframes 
for FDA's review of postmarketing studies; and information about 
postmarketing studies that will be available to the public. The draft 
guidance is intended to assist applicants in meeting the requirements 
of section 130 of the Food and Drug Administration Modernization Act of 
1997.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by July 3, 
2001. Submit written comments on the information collection provisions 
by June 4, 2001. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Reports on the Status of 
Postmarketing Studies--Implementation of Section 130 of the Food and 
Drug Administration Modernization Act of 1997'' to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research (CDER), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The document may also be obtained by mail by 
calling CDER at 301-827-4573 or the CBER Voice Information System at 1-
800-835-4709 or 301-827-1800, or by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY 
INFORMATION: section for electronic access to the draft guidance 
document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Requests and comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:
    Sharon T. Risso, Center for Biologics Evaluation and Research (HFM-
500), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-5098; or
    James L. Cobbs, Center for Drug Evaluation and Research (HFD-102), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-5610.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Reports on the Status of Postmarketing 
Studies--Implementation of Section 130 of the Food and Drug 
Administration Modernization Act of 1997.'' Section 506B (``Reports of 
Postmarketing Studies'') of the Federal Food, Drug, and Cosmetic Act 
(the act, 21 U.S.C. 356b) provides FDA with additional authority for 
monitoring the progress of postmarketing studies that drug and 
biologics applicants have made a commitment to conduct. Postmarketing 
studies are those studies conducted after approval to gather 
information about approved drug or biologics products. Such studies are 
used to gather additional information about product safety, efficacy, 
or optimal use.
    Under 506B(a) of the act, an applicant who has entered into an 
agreement with FDA to conduct a postmarketing study is required to 
provide the agency with an annual report on the status of the study 
until the study is completed or terminated. The annual report must 
address the progress of the study or the reasons for the failure of the 
applicant to conduct the study. Section 506B(c) of the act directs FDA 
to develop and publish annually in the Federal Register a report on the 
status of postmarketing studies that applicants have made a commitment 
to conduct and for which status reports have been submitted. In the 
Federal Register of October 30, 2000 (65 FR 64607), the agency 
published a final rule to implement section 506B of the act. The final 
rule makes several changes to the existing regulations for approved 
human drugs and licensed biological products.
    This draft guidance, when finalized, is intended to provide 
information on the following: (1) Procedures concerning the submission 
of postmarketing study status reports; (2) the content and format of a 
postmarketing study status report; (3) timeframes for FDA's review of 
postmarketing study reports; and (4) information about postmarketing 
studies that will be available to the public. This draft guidance would 
be applicable to postmarketing studies for approved human drug products 
and licensed biological products that meet the definition of ``drug'' 
under the act. It would not apply to biological products that meet the 
definition of medical ``device'' under the act; or to veterinary drug 
products, which will be addressed separately.
    The draft guidance is being issued consistent with FDA's good 
guidance

[[Page 17913]]

practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This draft guidance document represents the agency's current thinking 
on the submission of postmarketing study reports for approved human 
drug or licensed biological products. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations. As with 
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to 
all situations.

II. Comments

    This draft document is being distributed for comment purposes only, 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Submit written 
comments to ensure adequate consideration in preparation of the final 
document by July 3, 2001. Two copies of any comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in the brackets in the heading 
of this document. A copy of the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), 
Federal agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection, FDA invites comments on: 
(1) Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.

Draft Guidance for Industry: Reports on the Status of Postmarketing 
Studies--Implementation of Section 130 of the Food and Drug 
Administration Modernization Act of 1997

    This draft guidance document is intended to complement the final 
rule that implemented section 506B of the act by describing in greater 
detail the content, format, and timing requirements for the 
postmarketing study reports required to be submitted to FDA by section 
506B. In compliance with section 3507(d) of the PRA (44 U.S.C. 
3507(d)), the agency has submitted the information collection 
provisions of the final rule to OMB for review.
    In addition to the information collection provisions of the final 
rule submitted to OMB, this draft guidance would recommend an 
additional information collection. The draft guidance proposes that 
applicants with postmarketing study commitments submit with their 
annual report a redacted version of each status report that already has 
been formatted and completed for submission. Applicants would redact 
complete reports to the extent necessary to protect trade secrets or to 
conceal individual patient identifiers. FDA would use this redacted 
report for release to the public on its website and in the report on 
the status of postmarketing studies required under section 506B(c) of 
the act. FDA would accept the redacted version of the applicant's 
status report either in an electronic format compatible with FDA's 
electronic database or in hard copy.
    Respondents to this information collection are applicants holding 
approved applications for human drugs and biological products that are 
required or have committed to conduct postmarketing studies.
    Based on agency records, there are approximately 183 drug 
applicants who are required or who have committed to conduct 
approximately 462 postmarketing studies and approximately 33 applicants 
holding approved biologics license applications who are required or who 
have committed to conduct approximately 86 postmarketing studies. The 
agency assumes that all of the estimated 216 respondents would submit 
voluntarily approximately 548 redacted versions of their annual status 
reports. Based on FDA experience, the agency estimates that an 
applicant would expend a total of 0.5 hours preparing a redacted 
version of each status report that already has been formatted and 
completed for submission.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
                                     Annual
                         No. of    Frequency    Total     Hours    Total
                      Respondents     per      Annual      per     Hours
                                    Response  Response  Response
------------------------------------------------------------------------
Redacted Version for       216         2.5       548       0.5      274
 Public Release
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    In compliance with section 3507(d) of the PRA, the agency is 
submitting the information collection provisions of this draft guidance 
to OMB for review.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.fda.gov/cder/guidance/index.htm, or at http://www.fda.gov/cber/guidelines.htm.


[[Page 17914]]


    Dated: March 21, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-8199 Filed 4-3-01; 8:45 am]
BILLING CODE 4160-01-S