31316 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

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. 

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 (§ 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 

(§ 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 

(§ 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

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

607.20(a), 607.21, 607.22, 607.25, 607.40; Initial registration ........... 152 1 152 1 ...................................... 152 

607.21, 607.22, 607.25, 607.26, 607.31, 607.40; Annual registration 2,557 1 2,557 0.5 (30 minutes) ............. 1,279 

607.21, 607.25, 607.30(a), 607.31, 607.40; Product listing update .... 256 1 256 0.25 (15 minutes) ........... 64 

607.22(b); Waiver request ................................................................... 1 1 1 1 ...................................... 1 

Total .............................................................................................. ........................ ........................ ........................ ......................................... 1,496 

1There 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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