[Federal Register: January 16, 2004 (Volume 69, Number 11)]
[Notices]
[Page 2601-2602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja04-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0267]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 17, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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,
[[Page 2602]]
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 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).
In the Federal Register of June 26, 2003 (68 FR 38066), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Total
21 CFR Section No. of Annual Frequency per Annual Hours per Total Hours
Respondents Response Responses Response
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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: January 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-943 Filed 1-15-04; 8:45 am]
BILLING CODE 4160-01-S