Notice2024-05215
Agency Information Collection Activities; Proposed Collection; 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
March 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements in the Agency's regulations relating to establishment registration and product listing for manufacturers of human blood and blood products and licensed devices.
Full Text
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<title>Federal Register, Volume 89 Issue 49 (Tuesday, March 12, 2024)</title>
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[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17856-17858]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0783]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection requirements in
the Agency's regulations relating to establishment registration and
product listing for manufacturers of human blood and blood products and
licensed devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 13, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 13, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-0783 for ``Establishment Registration and Product Listing
for Manufacturers of Human Blood and Blood Products and Licensed
Devices.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly
[[Page 17857]]
available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#e8b8baa9bb9c898e8ea88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="09595b485a7d686f6f496f6d682761617a276e667f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 helps support implementation of section
510 of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360), as well
as related Agency regulations in 21 CFR part 607 and forms. All owners
or operators of establishments that manufacture human blood and blood
products are required to register with the FDA, unless they are exempt
under 21 CFR 607.65. A list of every blood product manufactured,
prepared, or processed for commercial distribution must also be
submitted, among other information. Establishments must register within
5 days after beginning operations or submission of a biologics license
application, and register annually between October 1 and December 31.
The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufactures of
human blood and blood products and licensed devices, including initial
registration and product listing, annual registration, product listing
updates and waiver requests. Owners or operators of certain
establishments that engage in the manufacture of blood products must
register and submit a list of every blood product in commercial
distribution (21 CFR 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 through the FDA Industry
Systems page available at <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. More information
about the eBER system is available at: <a href="https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing">https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing</a>. Online instructions are
available at: <a href="https://www.fda.gov/media/116432/download?attachment">https://www.fda.gov/media/116432/download?attachment</a>. The
Form FDA 2830 previously associated with this information collection is
no longer in use.
FDA may grant a request for waiver of this requirement prior to the
date on which the information is due (21 CFR 607.22(a)). Waiver
requests must be submitted in writing and must include, among other
information, the specific reasons why electronic registration is not
reasonable for the registrant.
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.
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 Total hours
respondents respondent responses per response
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607.20(a), 607.21, 607.22, 176 1 176 1............... 176
607.25, 607.40; Initial
registration and submission
of product listing.
607.21, 607.22, 607.25, 2,545 1 2,545 0.5 (30 minutes) 1,273
607.26, 607.31, 607.40;
Annual registration.
607.21, 607.25, 607.30(a), 42 1 42 0.25 (15 10
607.31, 607.40; Product minutes).
listing update.
[[Page 17858]]
607.22(b); Written waiver 1 1 1 1............... 1
request.
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Total......................... .............. .............. .............. ................ 1,460
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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 calendar year 2022 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 decrease in
product listing updates and an increase in the number of initial
registrations. Our estimated burden for the information collection
reflects an overall decrease of 36 hours.
Dated: March 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05215 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
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