0052 SSA 2018 Ext

U.S. Food and Drug Administration
Blood Establishment Registration and Product Listing
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, the
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. Regulations at 21 CFR part 607 (21 CFR 607) set forth
establishment registration and product listing requirements for manufacturers of products that
meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
and that are licensed under section 351 of the Public Health Service Act.
In accordance with statutory requirements, registration information is submitted electronically
and must be submitted annually as prescribed in the regulations through FDA’s Blood
Establishment Registration and Product Listing system. The regulations also provide for
waivers. Requests for a waiver of the requirements from 21 CFR 607.22(a), use of the
electronic Blood Establishment Registration and Product Listing system, can be made in
writing stating the specific reasons why electronic submission is not reasonable for the
registrant. Waivers may be approved by FDA with FDA specifying the terms and duration of
the waiver.
We therefore request extension of OMB approval for the information collection provisions
found under 21 CFR Part 607; the electronic Blood Establishment Registration and Product
Listing system; and associated Form FDA 2830 entitled “Blood Establishment Registration and
Product Listing,” which we retain for use in cases where waivers have been granted.
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. The information
collection enables FDA to fulfill its public health protection responsibilities by ensuring the
safety of the nation’s blood supply. The information is necessary as well in the event of a
product recall.
3. Use of Improved Information Technology and Burden Reduction
Since last OMB review, rulemaking (RIN 0910-0049) revised the regulations to conform with
section 510 of the FD&C act, as amended by the Food and Drug Administration Amendments
Act, to require electronic submissions. We believe utilizing electronics means will improve

management of drug establishment registration and drug listing requirements, including
biologics, and to make these processes more efficient and effective for both respondents and
FDA. We remain open to technological advancements that would enhance or otherwise refine
the current system and will employ such improvements as resources permit.
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 607.
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 our Regional Small Business Representatives 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 agency 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 for 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 December 26, 2017 (82 FR 61013). No comments were received in
response to the notice.
9. Explanation of any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) and FDA’s published regulations of “Public Information” under 21
CFR Part 20, which prohibit FDA from releasing to the public the names of patients, individual

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reporters, health care practitioners, hospitals, and any geographical identifiers. This
information is for internal use and may be subject to, in whole or part, the FOIA and applicable
FDA regulations.
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the annual hourly burden for the information collection as follows:
TABLE 1 – Estimated Annual Reporting Burden
21 CFR Part 607 –
Procedures for Domestic and
Foreign Blood Establishments

No. of
Respondents

Initial establishment
registration and product
listing
Annual update of
establishment registration and
blood product listing

115

1

115

1

115

2,812

1

2,812

0.5
(between 1530 mins.)

1,356

25

1

25

1

25

Waiver requests

No. of
Responses
Per
Respondent

Total
Annual
Responses

Average
Burden per
Response

TOTAL
1

Total
Hours

1,496

There are no capital or operating or maintenance costs associated with the information collection.

Respondents to the collection of information are human blood and plasma donor
centers, blood banks, certain transfusion services, other blood product manufacturers, and
independent laboratories that engage in quality control and testing for registered blood product
establishments. Our estimate of the information collection burden is based on agency data and
our experience with the information collection. Based on our review, approximately 115 new
establishments initially register and list their products and that it will take one hour to do so.
We estimate there are approximately 2,612 respondents who will submit annual updates of
establishment registration and 200 will submit product listings, and that this will require
between 15 and 30 minutes. Finally, we estimate 25 waivers will be submitted, and that it takes
one hour to do so.
12b. Annualized Cost Burden Estimate
We estimate an annualized cost to respondents of $194,952. This cost is based on a pay
rate of $44/hour for a medical technologist, $59/hour for a supervisor, and $96/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.

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The average salary based on these estimates is $66. The salary estimates include benefits but
no overhead costs.
Activity
Initial Registration
Annual Registration
Product Listing Update
Waiver Requests
Total

Cost to Respondents
Number of Hours
Cost per Hour
115
$66
2,612
$66
200
$66
25
$66

Total Cost
$7,590
$172,392
$13,320
$1,650
$194,952

13. Estimates of Other Total Annual Costs to Respondents and/or Record Keepers
There are no capital start-up, operating or maintenance costs associated with this collection of
information.
14. Annualized Cost to Federal Government
The estimated annualized cost to the Federal Government is $142,500. We calculated this cost
assuming a 1½ full time employee allocation with an annual salary of $95,000 (1.5 x $95,000).
This figure reflects pay for a Technical Information Specialist (GS-11/5) 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. Due to an increase in the number
blood establishment registrations submitted to FDA, we have increased our estimate of the
number respondents to the collection. This results in an increase of 95 annual hours and 244
annual responses.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
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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