Document ID: FDA-2014-N-1069-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
Posted Date: 2017-12-26T05:00Z

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61013-61015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27757]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Blood Establishment Registration and Product Listing, 
Form FDA 2830

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection requirements 
relating to the blood establishment registration and product listing 
requirements in the Agency's regulations and Form FDA 2830.

DATES: Submit electronic or written comments on the collection of 
information by February 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 26, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1069 for ``Blood Establishment Registration and Product 
Listing, Form FDA 2830.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance

[[Page 61014]]

of FDA's functions, including whether the information will have 
practical utility; (2) the accuracy of FDA's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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)) 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.
    FDA estimates the burden of this collection of information as 
follows:

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

[[Page 61015]]

    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: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27757 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P