Notice2021-16384
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) 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.
Full Text
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<title>Federal Register, Volume 86 Issue 145 (Monday, August 2, 2021)</title>
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[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41488-41490]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16384]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2002-N-0314]
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.
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SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by September 1, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>.
[[Page 41489]]
Find this particular information collection by selecting ``Currently
under Review--Open for Public Comments'' or by using the search
function. The OMB control number for this information collection is
0910-0206. Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="78282a392b0c191e1e381e1c195610100b561f170e">[email protected]</span></a>.
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
This information collection supports Agency regulations. 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, 660.36, and 660.46 (21 CFR
660.6, 660.36, and 660.46).
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 CBER, 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 CBER, 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 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 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 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 75
manufacturers submitted samples and protocols in fiscal year (FY) 2020
under the regulations cited previously in this document. FDA estimates
that approximately 72 manufacturers submitted protocols under Sec.
610.2, and 3 manufacturers submitted protocols under the regulation
(Sec. 660.6) for the other specific product. FDA received no
submissions under Sec. Sec. 660.36 or 660.46; however, FDA is using
the estimate of one protocol submission under each regulation in the
event that protocols are submitted in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2020 for the various submission requirements of
samples and protocols for the licensed biological products. The average
burden per response is based on information provided by industry. The
burden estimates provided by industry ranged from 1 hour 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 average burden per response is 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 other protocols than under
Sec. 610.2.
In the Federal Register of March 16, 2021 (86 FR 14448), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 41490]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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610.2, Requests for Samples and 72 82.972 5,974 3 17,922
Protocols; Official Release....
660.6(b), Protocols............. 3 4 12 5 60
660.36(a)(2) and (b), Samples 1 1 1 6 6
and Protocols..................
660.46(b), Protocols............ 1 1 1 5 5
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Total....................... 77 .............. 5,988 .............. 17,993
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall decrease of 1,463 hours and a corresponding decrease of 491
responses. We attribute this adjustment to a decrease in the number of
submissions we received over the last few years.
Dated: July 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16384 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P
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