0052_Supporting Statement_2021

0052_Supporting Statement_2021.pdf

Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

OMB: 0910-0052

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Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices
21 CFR Part 607
OMB Control No. 0910-0052
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations. Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360), any person owning or operating an establishment that manufactures, prepares,
propagates, compounds, or processes a drug or a device, as well as licensed biological
products used in the manufacture of a licensed 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.
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, 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)).
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 listed under section 351 of the Public Health
Service Act.
We therefore request extension of OMB approval for the information collection provisions
found in the regulations at 21 CFR part 607; the electronic Blood Establishment Registration
and Product Listing system (BER); and associated collection instruments, as discussed in this
supporting statement.

2. Purpose and Use of the Information Collection
The information collection is used by FDA, and other government agencies, to keep an
accurate list of all foreign and domestic blood establishments and their products. 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. The information is necessary especially in the event of a
product recall.
3. Use of Improved Information Technology and Burden Reduction
Electronic submission of blood establishment and product listing information is required
under 21 CFR 607.22, unless waived in certain circumstances. Blood establishments that
must register and list electronically under 21 CFR part 607 should use the electronic Blood
Establishment Registration (BER) system to meet the requirement for electronic submission
of establishment registration and product listing. We estimate that nearly all of the
establishment registration and product listing information will be submitted electronically in
the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although GMP or quality system (QS)
regulations appear in several parts of Title 21 (Food and Drugs) of the CFR, this collection
covers provisions associated with requirements for biologics regulated under 21 CFR part
5. Impact on Small Businesses or Other Small Entities
Under the FD&C Act, any person owning or operating a blood establishment must register
with the Secretary of Health and Human Services, however we do not believe the
requirements impose undue burden on small entities. At the same time, we assist small
businesses in complying with agency requirements through CBER’s Office of
Communication, Outreach and Development (OCOD) and through the scientific and
administrative staffs within the agency. We also provide a Small Business Guide on our
website at http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements
and reflects a regulatory scheme designed to ensure the safety of the nation’s blood supply.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in
the Federal Register of February 18, 2021 (86 FR 10085). No comments were received in
response to the notice.


9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this supporting statement, we consulted our Privacy Office to ensure appropriate
identification and handling of information collected. Although personally identifiable
information (PII) is collected, it pertains the subject individuals’ professional capacity and the
FDA-related work performed for their employer (e.g., point of contact at a regulated entity).
The PII submitted is contact information submitted with a written request for an exception or
alternative to labeling requirements that might include name, address, telephone number,
email address and fax number. Through appropriate guidance, we limit submission fields and
minimized the PII collected to protect the privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to
government documents. However, FOIA provides certain exemptions from mandatory public
disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible
disclosure of records to the public, consistent with the rights of individuals to privacy, the
property rights of persons in trade and confidential commercial or financial information.
11. Justification for Sensitive Questions
This collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden
21 CFR Part 607;
No. of
No. of
IC Activity
Respondents Responses
607.20(a), 607.21, 607.22, 607.25,
607.40; initial registration
607.21, 607.22, 607.25, 607.26,
607.31, 607.40; annual registration
607.21, 607.25, 607.30(a), 607.31,
607.40; product listing update
607.22(b); waiver request

Burden per
(in hours)




(30 min.)
(15 min.)


12b. Annualized Cost Burden Estimate
We estimate an annualized cost to respondents of $216,518. This cost is based on a
pay rate of $49/hour for a medical technologist, $65/hour for a supervisor, and $106/hour for
a Medical Director, who may be responsible for registering an establishment, recording and
listing blood products, and has the training and skills to handle various reporting
requirements. The average salary based on these estimates is $73. The salary estimates
include benefits but no overhead costs.


Initial Registration
Annual Registration
Product Listing Update
Waiver Requests

Cost to Respondents
Number of Hours
Cost per Hour

Total Cost

13. Estimates of Other Total Annual Costs to Respondents/Record Keepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this collection
of information.
14. Annualized Cost to the Federal Government
The estimated annualized cost to the Federal Government is $148,200. We calculated this
cost assuming a 1½ full time employee allocation with an annual salary of $98,800 (1.5 x
$98,800). This figure reflects pay for a Technical Information Specialist (GS-12/5) to review
and process registration forms, input data, and maintain the database. Salary estimate includes
benefits but no overhead costs.
15. Explanation for Program Changes or Adjustments
The information collection reflects agency adjustments. 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 to reflect an increase in
annual product listing updates by 14 responses annually.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.


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File Modified2021-06-10
File Created2021-06-10

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