[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Notices]
[Pages 37714-37715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17978]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0097]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request for Samples
and Protocols
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 August
28, 2009.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0206.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Request for Samples and Protocols--(OMB Control Number 0910-0206)--
Extension
Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure the safety, purity, and potency of
biological products and to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under Sec. 610.2 (21 CFR 610.2), the Center for Biologics Evaluation
and Research (CBER) or the Center for Drug Evaluation and Research may
at any time require manufacturers of licensed biological products to
submit to FDA samples of any lot along with the protocols showing the
results of applicable tests prior to distributing the lot of the
product. In addition to Sec. 610.2, there are other regulations that
require the submission of samples and protocols for specific licensed
biological products: Sec. Sec. 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21 CFR 660.36) (Reagent Red Blood
Cells); and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen).
Section 660.6(a) provides requirements for the frequency of submission
of samples from each lot of Antibody to Hepatitis B Surface Antigen
product, and Sec. 660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot. Section
660.46(a) contains requirements as to the frequency of submission of
samples from each lot of Hepatitis B Surface Antigen product, and Sec.
660.46(b) contains the requirements as to the submission of a protocol
containing specific information along with each required sample. For
Sec. 660.46 products subject to official release by FDA, one sample
from each filling of each lot is required to be submitted along with a
protocol consisting of a summary of the history of manufacture of the
product, including all results of each test for which test results are
requested by CBER. After notification of official release is received,
one sample along
[[Page 37715]]
with a protocol is required to be submitted at 90-day intervals. In
addition, samples, which must be accompanied by a protocol, may at any
time be required to be submitted to CBER if continued evaluation is
deemed necessary.
Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec. 610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec. 660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 69
manufacturers submitted samples and protocols in fiscal year (FY) 2008,
under the regulations cited previously in this document. FDA estimates
that approximately 65 manufacturers submitted protocols under Sec.
610.2 and 21 CFR 610.3 manufacturers submitted protocols under the
regulations (Sec. Sec. 660.6 and 660.46) for the other specific
products. FDA received no submissions under Sec. 660.36; however, FDA
is using the estimate of one protocol submission in the event one is
submitted in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2008, which totaled 6,314, for the various
submission requirements of samples and protocols for the licensed
biological products. The rate of final actions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry. The burden estimates
provided by industry ranged from 1 to 5.5 hours. Under Sec. 610.2, the
hours per response are based on the average of these estimates and
rounded to 3 hours. Under the remaining regulations, the hours per
response are based on the higher end of the estimate (rounded to 5 or 6
hours) since more information is generally required to be submitted in
the other protocols than under Sec. 610.2.
In the Federal Register of March 6, 2009 (74 FR 9820), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
610.2 65 95.5 6,208 3 18,624
----------------------------------------------------------------------------------------------------------------
660.6(b) 2 44 88 5 440
----------------------------------------------------------------------------------------------------------------
660.36(a)(2) and 1 1 1 6 6
(b)
----------------------------------------------------------------------------------------------------------------
660.46(b) 1 17 17 5 85
----------------------------------------------------------------------------------------------------------------
Total 69 ................. 6,314 ................. 19,155
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17978 Filed 7-28-09; 8:45 am]
BILLING CODE 4160-01-S