[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27820-27821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-50]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0516]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Request for Samples and Protocols
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Fax or electronically mail written comments on the collection of
information by June 20, 2003.
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
electronically mailed to sshapiro@omb.eop.gov or faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk
Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (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.
Request for Samples and Protocols--(OMB Control Number 0910-0206)--
Extension
Under section 351 of the Public Health Service Act (the PHS 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 licenses for such products
are only issued when a product meets the prescribed standards. Under
Sec. 610.2 (21 CFR 610.2), FDA 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 before
marketing the lot of the product. In addition to Sec. 610.2, there are
other regulations in part 660 (21 CFR part 660) that require the
submission of samples and protocols for specific licensed biological
products: Sec. Sec. 660.6 (Antibody to Hepatitis B Surface Antigen),
660.36 (Reagent Red Blood Cells), and 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 or manufacture of the product, including all results of each
test for which test results are requested by the Center for Biologics
Evaluation and Research (CBER). After official release is no longer
required, one sample along with a protocol is required to be submitted
at an interval of 90 days. In addition, samples, which must be
accompanied by a protocol, may at any time be required to be submitted
to FDA 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 a protocol contain information including, but not
limited to, manufacturing records, test records, and test results.
Section 660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to FDA at the
time of initial distribution of each lot. Section 660.46(a) provides
requirements for the frequency of submission of samples from each lot
of Hepatitis B Surface Antigen product, and Sec. 660.46(b) provides
the requirements for 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 or 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
with a protocol is required to be submitted at an interval of 90 days.
In addition, samples, which must be
[[Page 27821]]
accompanied by a protocol, may at any time be required to be submitted
to FDA if continued evaluation is deemed necessary. Samples and
protocols are required by FDA to help ensure the safety, purity, or
potency of the 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
specified biotechnology and specified synthetic 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 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 any
licensed biological product. 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. 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. There are an estimated 329
manufacturers of licensed biological products, however, based on
information obtained from FDA's database system, approximately 83
manufacturers submitted samples and protocols in fiscal years 1999 and
2000, under the regulations cited previously. FDA estimates that
approximately 76 manufacturers submitted protocols under Sec. 610.2
and 7 manufacturers submitted protocols under the regulations for the
specific products. The total annual responses are based on the annual
average of FDA's final actions completed in fiscal years 1999 and 2000,
which totaled 6,747, for the various submission requirements of samples
and protocols for 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) because more information is generally required to be
submitted in the protocol than under Sec. 610.2.
In the Federal Register of December 27, 2002 (67 FR 79127), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received one comment on the information
collection in response to the 60-day notice.
The comment recommended that we should review the regulations under
Sec. 610.2(a) concerning lot release and consider modifications to
reflect current manufacturing technology standards in light of
industry's ability to control and test products to ensure identity,
purity, and potency. The comment provided some suggestions to consider
regarding the lot release requirements.
The comment's suggested regulatory revisions that pertain to
provisions or matters that are outside the scope of the proposed
information collection. Consequently, we decline to adopt the comment's
recommendations.
FDA estimates the burden of this information collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual frequency Total annual Hours per
21 CFR Section respondents per response responses response Total hours
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610.2 76 86.5 6,574 3 19,722
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660.6(b) 4 28.5 114 5 570
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660.36(a)(2) and 1 1 1 6 6
(b)
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660.46(b) 2 29 58 5 290
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Total 83 .................. 6,747 ................. 20,588
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12724 Filed 5-20-03; 8:45 am]
BILLING CODE 4160-01-S