Document ID: FDA-2020-N-2231-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-06-11T04:00Z

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
PRAStaff@fda.hhs.gov.

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]
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