[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Pages 24720-24721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9894]



Food and Drug Administration

[Docket No. FDA-2011-N-0827]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Revisions to Labeling 
Requirements for Blood and Blood Components, Including Source Plasma

AGENCY: Food and Drug Administration, HHS.

[[Page 24721]]

ACTION: Notice.


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 25, 

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-New and 
title ``Revisions to Labeling Requirements for Blood and Blood 
Components, Including Source Plasma.'' Also include the FDA docket 
number found in brackets in the heading of this document.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 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.

Revisions to Labeling Requirements for Blood and Blood Components, 
Including Source Plasma--(OMB Control Number 0910-NEW)

    FDA is finalizing the labeling requirements for blood or blood 
components intended for use in transfusion or for further manufacture 
under the provisions of the Public Health Service Act (PHS Act) (42 
U.S.C. 262-264), and the drugs, devices, and general administrative 
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these 
provisions of the PHS Act and the FD&C Act, we have the authority to 
issue and enforce regulations designed to ensure that biological 
products are safe, pure, potent, and properly labeled, and to prevent 
the introduction, transmission, and spread of communicable disease.
    Under this rulemaking, FDA is consolidating the regulations related 
to labeling blood and blood components. Regulations for labeling of 
blood and blood components will be consolidated into Sec.  606.121 
(Container label) (21 CFR 606.121) and Sec.  606.122 (Circular of 
information) (21 CFR 606.122). This notice solicits comments on the 
information collection associated with Sec.  606.121(c)(11), which 
requires that if the product is intended for further manufacturing use, 
a statement listing the results of all the tests for communicable 
disease agents required under Sec.  610.40 (21 CFR 610.40) for which 
the donation has been tested and found negative must be on the 
container label; except that the label for Source Plasma is not 
required to list the negative results of serological syphilis testing 
under Sec.  610.40(i) and 21 CFR 640.65(b). In addition, this notice 
also solicits comments on the information collection associated with 
Sec.  606.121(e)(2)(i), which requires that the product labels of 
certain red blood cells must include the type of additive solution with 
which the product was prepared.
    The Agency believes the rule amendments and the information 
collection provisions under Sec.  606.121(c)(11) and (e)(2)(i) in the 
final rule are part of usual and customary business practice and do not 
create any new burden for respondent.
    The collection of information requirements under Sec. Sec.  606.121 
and 606.122 are approved under OMB control number 0910-0116 and those 
in 21 CFR 640.70 have been approved under OMB control number 0910-0338. 
Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources 
necessary to comply with a collection of information are excluded from 
the burden estimate if the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary because they would 
occur in the normal course of activities.
    In the Federal Register of December 30, 2011 (76 FR 82300), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

    Dated: April 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9894 Filed 4-24-12; 8:45 am]