Document ID: FDA-2014-N-1069-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Blood
Establishment Registration and Product Listing
Posted Date: 2015-01-29T05:00Z

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4932-4933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01670]

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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

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 March 
2, 2015.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 his or her name, place of business, and all such 
establishments with the Secretary of Health and Human Services on or 
before December 31 of each year. He or she must also submit, among 
other information, a listing of all drug or device products 
manufactured, prepared, propagated, compounded, or processed by him or 
her for commercial distribution. 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), in brief, requires owners or operators of 
certain establishments that engage in the manufacture of blood products 
to register and to submit a list of every blood product in commercial 
distribution.
    Section 607.21, in brief, requires the owners or operators of 
establishments entering into the manufacturing of blood products to 
register 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 November 15 and December 31 and 
update their blood product listing every June and December.
    Section 607.22 requires the use of Form FDA 2830, Blood 
Establishment Registration and Product Listing, for initial 
registration, for subsequent annual registration, and for blood product 
listing information.
    Section 607.25 sets forth the information required for 
establishment registration and blood product listing.
    Section 607.26, in brief, requires certain changes to be submitted 
on FDA Form 2830 as an amendment to

[[Page 4933]]

establishment registration within 5 days of such changes.
    Section 607.30(a), in brief, sets forth the information required 
from owners or operators of establishments when updating their blood 
product listing information every June and December, or at the 
discretion of the registrant at the time the change occurs.
    Section 607.31 requires that additional blood product listing 
information be provided upon FDA request.
    Section 607.40, in brief, requires certain foreign blood product 
establishments to comply with the establishment registration and blood 
product listing information requirements discussed earlier in this 
document and to provide the name and address of the establishment and 
the name of the individual responsible for submitting the establishment 
registration and blood product listing information, as well as the 
name, address, and phone number of its U.S. agent.
    Among other uses, this information assists FDA in its inspections 
of facilities and is essential to the overall regulatory scheme 
designed to ensure the safety of the Nation's blood supply. Form FDA 
2830 is used to collect this information.
    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.
    In the Federal Register of August 11, 2014 (79 FR 46838), 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                    Form FDA 2830           Number of     responses per   Total annual      Average  burden per       Total
                                                                      respondents     respondent       responses             response            hours
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607.20(a), 607.21, 607.22, 607.25, and   Initial Registration.....              68               1              68  1........................         68
 607.40.
607.21, 607.22, 607.25, 607.26, 607.31,  Re-registration..........           2,615               1           2,615  0.5 (30 minutes).........      1,308
 and 607.40.
607.21, 607.25, 607.30(a), 607.31, and   Product Updating List....             166               1             166  0.25 (15 minutes)........         42
 607.40.
    Total..............................  .........................  ..............  ..............  ..............  .........................      1,418
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\1\ There are no capital costs of operating and maintenance costs associated with this collection of information

    FDA estimates the burden of this collection of information based 
upon information obtained from FDA's Center for Biologics Evaluation 
and Research's database and FDA experience with the blood establishment 
registration and product listing requirements.

    Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01670 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P