[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15147-15148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1069]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Blood Establishment 
Registration and Product Listing, Form FDA 2830

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by May 9, 
2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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, 
[email protected].

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.

Blood Establishment Registration and Product Listing, Form FDA 2830--21 
CFR part 607 OMB Control Number 0910-0052--Extension

    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 list of all drug and all 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.
    Section 607.20(a), requires, in part, that owners or operators of 
certain establishments that engage in the manufacture of blood products 
register and submit a list of every blood product in commercial 
distribution.
    Section 607.21 requires the owner or operator of an establishments 
entering into the manufacturing of blood products to register the 
establishment within 5 days after beginning such operation and to 
submit a list of every blood product in commercial distribution at the 
time. If the owner or operator of the establishment has not previously 
entered into such operation for which a license is required, 
registration must follow within 5 days after the submission of a 
biologics license application. In addition, owners or operators of all 
establishments so engaged must register annually between October 1 and 
December 31 and update their blood product listing every June and 
December.
    Section 607.22(a) requires, in part, that initial and subsequent 
registrations and product listings be submitted electronically through 
the Blood Establishment Registration and Product Listing system or any 
future superseding electronic system.
    Section 607.22(b) requires, in part, that requests for a waiver of 
the requirements of Sec.  607.22 be submitted in writing and include 
the specific reasons why electronic submission is not reasonable for 
the registrant.
    Section 607.22(c) provides that if FDA grants the waiver request, 
FDA may limit its duration and will specify the terms of the waiver and 
provide information on how to submit establishment registration, drug 
listings, other information, and updates, as applicable (e.g., Form FDA 
2830).
    Section 607.25 sets forth the information required for 
establishment registration and blood product listing.
    Section 607.26 requires, in part, that certain changes, such as 
ownership or location changes, be submitted to FDA electronically as an 
amendment to establishment registration within 5 calendar days of such 
changes using the FDA Blood Establishment Registration and Product 
Listing system, or any future superseding electronic system.
    Section 607.30(a), in part, sets forth the information required 
from owners or operators of establishments when they update their blood 
product listing information in June and December of each year (at a 
minimum).
    Section 607.31 requires that certain additional blood product 
listing information be provided upon request by FDA.
    Section 607.40 requires, in part, that certain foreign blood 
product establishments comply with the establishment registration and 
blood product listing information requirements in part 607, subpart B 
(Sec. Sec.  607.20 through 607.39, 607.40(a) and (b)), and provide the 
name and address of the establishment and the name of the individual 
responsible for submitting establishment registration and blood product 
listing information (Sec.  607.40(c))

[[Page 15148]]

as well as the name, address, and phone number of its U.S. agent (Sec.  
607.40(d)).
    This 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.
    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 the database of FDA's Center for 
Biologics Evaluation and Research and FDA experience with the blood 
establishment registration and product listing requirements.
    In the Federal Register of December 26, 2017 (82 FR 61013), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                    Number of
            21 CFR section              Activity/form FDA 2830      Number of     responses per   Total annual      Average burden per      Total hours
                                                                   respondents     respondent       responses            response
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607.20(a), 607.21, 607.22, 607.25,     Initial Registration....             115               1             115  1......................             115
 and 607.40.
607.21, 607.22, 607.25, 607.26,        Annual Registration.....           2,612               1           2,612  0.5....................           1,306
 607.31, and 607.40.                                                                                             (30 minutes)...........
607.21, 607.25, 607.30(a), 607.31,     Product Listing Update..             200               1             200  0.25...................              50
 and 607.40.                                                                                                     (15 minutes)...........
607.22(b)............................  Waiver Requests.........              25  ..............              25  1......................              25
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    Total............................  ........................  ..............  ..............  ..............  .......................           1,496
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\1\There are no capital costs of operating and maintenance costs associated with this collection of information.

    The burden for this information collection has changed since the 
last OMB approval. Because of a slight increase in the number of 
initial registrations and product listing updates FDA has received 
during the past 3 years, we have increased our reporting burden 
estimate.

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07145 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P


