Notice2021-12259
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
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
June 11, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, 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 111 (Friday, June 11, 2021)</title>
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31316]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12259]
[[Page 31316]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2231]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment
Registration and Product Listing for Manufacturers of Human Blood and
Blood Products and Licensed Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, 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 July 12, 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>. 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 0910-0052. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#aefefceffddacfc8c8eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="326260736146535454725456531c5a5a411c555d44">[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.
Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices--21 CFR Part 607
OMB Control Number 0910-0052--Extension
This information collection supports Agency regulations. Under
section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, places of
business, and all such establishments, among other information and must
submit a listing of all drug and device products manufactured,
prepared, propagated, compounded, or processed by him or her for
commercial distribution, among other information. In part 607 (21 CFR
part 607), FDA has issued regulations implementing these requirements
for manufacturers of human blood and blood products.
The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufacturers of
human blood and blood products and licensed devices, including initial
registration, annual registration, product listing updates, and waiver
requests. Owners or operators of certain establishments that engage in
the manufacture of blood products shall register and submit a list of
every blood product in commercial distribution (Sec. 607.20(a)).
Initial and subsequent registrations and product listings must be
submitted electronically through FDA's Center for Biologics Evaluation
and Research (CBER) Blood Establishment Registration and Product
Listing system, or any future superseding electronic system, unless FDA
has granted a request for waiver of this requirement prior to the date
on which the information is due (Sec. 607.22(a)). Waiver requests must
be submitted in writing and must include, among other information, the
specific reasons why electronic submission is not reasonable for the
registrant (Sec. 607.22(b)). Establishment registration and product
listing information assists FDA in its inspections of facilities, among
other uses, and its collection is essential to the overall regulatory
scheme designed to ensure the safety of the Nation's blood supply.
Description of Respondents: Respondents to this collection of
information are human blood and plasma donor centers, blood banks,
certain transfusion services, other blood product manufacturers,
independent laboratories that engage in quality control and testing for
registered blood product establishments and manufacturers of devices
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262).
In the Federal Register of February 18, 2021 (86 FR 10085), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
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 per response (in hours) Total hours
respondents respondent responses
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607.20(a), 607.21, 607.22, 607.25, 607.40; 152 1 152 1......................................... 152
Initial registration.
607.21, 607.22, 607.25, 607.26, 607.31, 2,557 1 2,557 0.5 (30 minutes).......................... 1,279
607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 607.40; 256 1 256 0.25 (15 minutes)......................... 64
Product listing update.
607.22(b); Waiver request................... 1 1 1 1......................................... 1
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Total................................... .............. .............. .............. .......................................... 1,496
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of Fiscal Year 2019 data from CBER's Blood
Establishment Registration and Product Listing system, we have adjusted
the currently approved burden estimate we attribute to establishment
registration and product listing to reflect a slight increase in
submissions; however, the overall burden has not changed.
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12259 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P
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