[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17856-17858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 https://www.access.fda.gov. More information 
about the eBER system is available at: https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing. Online instructions are 
available at: https://www.fda.gov/media/116432/download?attachment. 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]
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