[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38066-38067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-16160]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0267]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Studies for Licensed Biological
Products; Status Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to FDA regulations for the postmarketing studies
for licensed biological products.
DATES: Submit written or electronic comments on the collection of
information by August 25, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.fda.gov/dockets/ecomments. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under 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 including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed extension of
an existing collection of information set forth in this document.
With respect to the following collection of information, 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.
Postmarketing Studies for Licensed Biological Products; Status
Reports (OMB Control Number 0910-0433)--Extension
Section 130(a) of the Food and Drug Administration Modernization
Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic
Act (the act) by adding a new provision (section 506B of the act (21
U.S.C. 356b)) requiring reports of postmarketing studies for approved
human drugs and licensed biological products. Section 506B of the act
provides FDA with additional authority to monitor the progress of
postmarketing studies that applicants have made a commitment to conduct
and requires the agency to make publicly available information that
pertains to the status of these studies.
Under section 506B(a) of the act, applicants that have committed to
conduct a postmarketing study for an approved human drug or licensed
biological product must submit to FDA a status report of the progress
of the study or the reasons for the failure of the applicant to conduct
the study. This report must be submitted within 1 year after the U.S.
approval of the application and then annually until the study is
completed or terminated. The reporting requirements for applicants of
approved new drug applications and abbreviated new drug applications
are under Sec. 314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The
collection of information requirements for Sec. 314.81(b)(2)(vii) are
approved under OMB control number 0910-0001. The reporting requirements
for applicants of approved biologics license applications (BLAs) or
supplements to an application are under Sec. 601.70 (21 CFR 601.70).
Section 601.70 requires applicants of approved biologics license
applications or supplements to an application to submit to FDA
postmarketing status reports for studies of clinical safety, clinical
efficacy, clinical pharmacology, and nonclinical toxicology that are
required by FDA or that an applicant of a BLA commits to conduct, in
writing, at the time of approval of an application or a supplement to
an application, or after approval of an application or a supplement.
Information submitted in a status report for Sec. 601.70(b) is limited
to that which is needed to sufficiently identify each applicant that
has committed to conduct a postmarketing study, the status of the study
that is being reported, and the reasons, if any, for the applicant's
failure to conduct, complete, and report the study. Previously, status
reports were only for postmarketing studies in pediatric populations.
Section 601.28(c) (21 CFR 601.28(c)) requires that the status of
postmarketing pediatric studies be reported under Sec. 601.70 rather
than under Sec. 601.28 and therefore, the information collection
burden for postmarketing studies in pediatric populations is included
under Sec. 601.70.
Respondents to this collection of information are the applicants
holding approved applications for licensed biological products that
have committed to conduct postmarketing studies. Based on information
obtained from FDA's Center for Biologics Evaluation and Research
computerized application and license tracking database, the agency
estimates that approximately 44 applicants with 65 approved BLAs have
committed to conduct approximately
[[Page 38067]]
223 postmarketing studies and would be required to submit an annual
progress report on those postmarketing studies under Sec. 601.70.
Based on past experience with similar reporting requirements, the
agency estimates that it takes an applicant approximately 24 hours (8
hours per study x 3) annually to gather, complete, and submit the
appropriate information for each report (approximately two to four
studies per report). Included in these 24 hours is the time necessary
to prepare and submit two copies of the annual progress report of
postmarketing studies to FDA under Sec. 601.70(d).
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Response Total Hours
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601.70(b) and (d) 44 1.5 65 24 1,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16160 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S