0052 SS for Reg and List FR of AUG 2016

Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices
OMB Control No. 0910-0052
SUPPORTING STATEMENT

Justification
1. Circumstances Making the Collection of Information Necessary
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 the Federal Register of August 31, 2016 (81 FR 60170), the
Food and Drug Administration issued a final rule amending its regulations at 21 CFR part 607.
The final rule entitled, “Requirements for Foreign and Domestic Establishment Registration and
Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License
Application, and Animal Drugs,” revises 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.
Under § 607.22(a),blood establishments must submit initial and subsequent registration and
product listing electronically through the Blood Establishment Registration and Product Listing
system, or any future superseding electronic system. Under § 607.22(b), both domestic and
foreign establishments may request a waiver from the requirement to submit electronically. If
the waiver is granted, respondents may use Form FDA 2830, “Blood Establishment Registration
and Product Listing.”
Under § 607.25(b)(1), blood establishments are required to list blood products by the established
and proprietary name. Previously, manufacturers of plasma derivatives and bulk product
substances registered and listed under both parts 607 and 207. The final rule revises this
requirement by requiring persons who engage solely in the production of plasma derivatives,
bulk product substances, and recombinant version of plasma derivatives or animal derived
plasma derivatives to register and list only under part 207, however reduction in burden is
expected to be minimal (approximately 20 establishments).
Under § 607.40, foreign establishments must include information for the United States agent as
part of its initial and updated registration. The final rule requires submission of minimal
additional information (i.e., email address) for the United States agent. The final rule requires the
foreign establishment to report to FDA changes in the United States agent’s name, address,
telephone number, and email address within 30 calendar days of the change. The final rule
lengthens from 10 business days to 30 calendar days the time period for reporting changes in the
United States agent’s information to FDA.

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Accordingly, we are requesting approval of the revised information collection provisions found
in 21 CFR part 607, as well as Form FDA 2830, “Blood Establishment Registration and Product
Listing.”
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 supports the agency’s public health protection responsivities by enabling the
monitoring and inspection of manufacturers of life-saving biological products, including blood
products, and ensuring the safety of the nation’s blood supply.
3. Use of Improved Information Technology and Burden Reduction
The Center for Biologics Evaluation and Research (CBER) utilizes the Electronic Blood
Establishment Registration and Product Listing System for the blood establishment registration
and product listing process. The agency continually monitors and accepts feedback on its
systems and plans for improvements accordingly.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection requirements apply to all businesses alike. FDA provides assistance
for small businesses through guidance available at:
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/SmallBusinessRepresentatives/guidan
ce CBER’s Office of Communication, Outreach, and Development, Division of Manufacturer’s
Assistance and Training, also provides assistance to small businesses subject to FDA’s
regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of August 29, 2006 (71 FR 51276) FDA published a proposed rule
entitled, “Requirements for Foreign and Domestic Establishment Registration and Listing for
Human Drugs, Including Drugs that are Regulated Under a Biologics License Application,
and Animal Drugs,” including a PRA analysis and invited public comment. While several
comments were received, none addressed the four information collection topics solicited in the
proposal. Substantive comments are addressed in the agency’s final rule that published August
31, 2016 (81 FR 60170) at Section III and may be found under Docket No. FDA–2005–N–0464
(formerly Docket No. 2005N–0403). FDA finalized the rule in the Federal Register of August
31, 2016 (81 FR 60170) and again invited public comment. None were received regarding the
information collection.
9. Explanation of any Payment or Gift to Respondents
No payment or gift was 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
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
The estimated annual burden for this information collection is 1,401 hours.
TABLE 1 – Estimated Annual Reporting Burden
Activity; 21 CFR Sections

Initial Establishment Registration
and Product Listing; 607.22(a),
607.25(a) and (b)(3)

No. of
Respondents

68

No. of
Responses
Per
Respondent
1

Total
Annual
Responses

Average
Burden per
Response

68

1

Total
Hours

68

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Activity; 21 CFR Sections

Annual Review and Update of
Establishment Registration and
Blood Product Listing; 607.22(a),
607.25(a) and (b)(3)
Waiver requests; 607.22(b))

No. of
Respondents

No. of
Responses
Per
Respondent

Total
Annual
Responses

Average
Burden per
Response

2,615

1

2,615

0.5

1,308

25

1

25

1

25

TOTAL
1

Total
Hours

1,401

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

Respondents to this 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.
FDA estimates the burden of this collection of information based upon information obtained
from CBER’s database. The average burden per response is based on our experience with the
blood establishment registration and product listing requirements including initial registration,
re-registration, and product listing updates.
The blood establishments for the most part are familiar with the regulations and registration
requirements to fill out this form for the first time. Approximately 68 new Form FDA 2830s are
received annually. The blood establishments need only refer to their files or written instructions
for a small portion of the information required.
Under § 607.22(b), both domestic and foreign establishments may request a waiver from the
requirement that information must be provided to FDA in electronic format. We expect few
waiver requests because only a computer, Internet access, and an email address are needed to
register and list electronically. We estimate that approximately 25 manufacturers will request a
waiver annually and that each request will take approximately 1 hour to prepare and submit to
us.
12b. Annualized Cost Burden Estimate
The estimated annualized cost to the respondents is $170,604. This cost is based on a pay rate of
$42/hour for a medical technologist, $56/hour for a supervisor, and $91/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 $63. The salary estimates include benefits but no overhead
costs.

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Activity
Initial Registration
Updates
Waiver Requests
Total
13.

Cost to Respondents
Number of Hours
Cost per Hour
68
$63
2,615
$63
25
$63

Total Cost
$4,284
$164,745
$1,575
$170,604

Estimates of Other Total Annual Cost to Respondents and/or Record Keepers

There are no capital costs or operating and maintenance costs associated with this collection of
information.
14. Annualized Cost to Federal Government
The estimated annualized cost to the Federal Government is $140,828. This cost is based on 1½
Technical Information Specialists (GS-11/5) that review and process the registration forms, input
the data, and maintain the database. These salary estimates include benefits but no overhead
costs.
Activity
Registration Form
Review/Process
Total

Number of
FTEs
1.5

Average
Annual Salary
$93,885

Total Cost
$140,828
$140,828

15. Explanation for Program Changes or Adjustments
The information collection is being revised by rulemaking (see Q8 for public notice and
comment discussion). IC 2, “Annual review and update” consolidates two previously itemized
ICs (re-registration and product listing update) but reflects no change in burden. While we
expect slightly fewer respondents to the collection as a result of the requirement that certain
manufacturers of plasma derivatives and bulk product substances must register only under 21
part 207, we have added minor additional data elements. These are discussed under Qs 1 and 12
of this supporting statement and in Section III of the final rule (81 FR at 60170). IC 3 reflects
burden under § 607.22(b) – waiver requests, but shows an overall reduction to the collection by
141 responses and 17 hours that results from consolidating reporting elements under IC 2.
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 expiration date is appropriate.

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18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.