Document ID: FDA-2011-N-0827-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions
Posted Date: 2011-12-30T05:00Z

[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82300-82301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33555]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Revisions to Labeling Requirements for Blood and Blood 
Components, Including Source Plasma

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on certain labeling requirements for blood and 
blood components, including Source Plasma. These requirements will 
facilitate the use of a labeling system using machine-readable 
information that would be acceptable as a system for labeling blood and 
blood components, and the use of new labeling systems that may be 
developed in the future. Additionally, these requirements are issued to 
help ensure the continued safety of the blood supply and facilitate 
consistency in labeling.

DATES: Submit either electronic or written comments on the collection 
of information by February 28, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of

[[Page 82301]]

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
Juanmanuel.vilela@fda.hhs.gov.

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 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 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. This document 
solicits comments on certain labeling requirements for blood and blood 
components, including Source Plasma, finalized as part of a rule FDA is 
publishing elsewhere in this Federal Register entitled ``Revisions to 
Labeling Requirements for Blood and Blood Components, Including Source 
Plasma.''

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 
pursuant to 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 (21 U.S.C. 321, 
331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of 
the PHS Act and the Federal Food, Drug, and Cosmetic 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 21 CFR 606.122 (Circular of 
information). This notice solicits comments on the information 
collection associated with Sec.  606.121(c)(11) (21 CFR 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) (21 CFR 610.40(i)) and Sec.  640.65(b) (21 CFR 
640.65(b)). In addition, this notice also solicits comments on the 
information collection associated with Sec.  606.121(e)(2)(i) (21 CFR 
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 Sec.  
606.121(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.

    Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33555 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P