[Federal Register: January 16, 2004 (Volume 69, Number 11)]
[Page 2601-2602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
          21 CFR Section               No. of       Annual Frequency per      Annual     Hours per   Total Hours
                                     Respondents          Response          Responses     Response
601.70(b) and (d)                              44            1.5                    65           24        1,560
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: January 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-943 Filed 1-15-04; 8:45 am]