[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10085-10087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2231]


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 
pertaining to establishment registration and product listing for 
manufacturers of human blood and blood products and licensed devices.

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 19, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 10086]]

     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-2020-N-2231 for ``Establishment Registration and Product Listing 
for Manufacturers of Human Blood and Blood Products and Licensed 
Devices--21 CFR part 607.'' 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 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: 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, 
[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 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 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 (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,

[[Page 10087]]

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 (21 CFR 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 (21 CFR 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.
    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; information collection         Number of     responses per   Total annual    Average burden per response  (in hours)    Total hours
                   activity                       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: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03249 Filed 2-17-21; 8:45 am]
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