
[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41582-41583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16589]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1164]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Exceptions or 
Alternatives to Labeling Requirements for Products Held by the 
Strategic National Stockpile

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 (PRA).

DATES: Fax written comments on the collection of information by August 
15, 2014.

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 0910-0614. 
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.

Exceptions or Alternatives to Labeling Requirements for Products Held 
by the Strategic National Stockpile--(OMB Control Number 0910-0614)--
Extension

    Under the Public Health Service Act (PHS Act), the Department of 
Health and Human Services stockpiles medical products that are 
essential to the health security of the nation (see PHS Act, 42 U.S.C. 
247d-6b). This collection of medical products for use during national 
health emergencies, known as the SNS, is to ``provide for the emergency 
health security of the United States, including the emergency health 
security of children and other vulnerable populations, in the event of 
a bioterrorist attack or other public health emergency.''
    It may be appropriate for certain medical products that are or will 
be held in the SNS to be labeled in a manner that would not comply with 
certain FDA labeling regulations given their anticipated circumstances 
of use in an emergency. However, noncompliance with these labeling 
requirements could render such products misbranded under section 502 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
    Under Sec. Sec.  201.26, 610.68, 801.128, and 809.11 (21 CFR 
201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center 
Director may grant a request for an exception or alternative to certain 
regulatory provisions pertaining to the labeling of human drugs, 
biological products, medical devices, and in vitro diagnostics that 
currently are or will be included in the SNS if certain criteria are 
met. The appropriate FDA Center Director may grant an exception or 
alternative to certain FDA labeling requirements if compliance with 
these labeling requirements could adversely affect the safety, 
effectiveness, or availability of products that are or will be included 
in the SNS. An exception or alternative granted under the regulations 
may include conditions or safeguards so that the labeling for such 
products includes appropriate information necessary for the safe and 
effective use of the product given the product's anticipated 
circumstances of use. Any grant of an exception or alternative will 
only apply to the specified lots, batches, or other units of medical 
products in the request. The appropriate FDA Center Director may also 
grant an exception or alternative to the labeling provisions specified 
in the regulations on his or her own initiative.
    Under Sec.  201.26(b)(1)(i) (human drug products), Sec.  
610.68(b)(1)(i) (biological products), Sec.  801.128(b)(1)(i) (medical 
devices), and Sec.  809.11(b)(1)(i) (in vitro diagnostic products for 
human use), an SNS official or any entity that manufactures (including 
labeling, packing, relabeling, or repackaging), distributes, or stores 
such products that are or will be included in the SNS may submit, with 
written concurrence from an SNS official, a written request for an 
exception or alternative to certain labeling requirements to the 
appropriate FDA Center Director. Except when initiated by an FDA Center 
Director, a request for an exception or alternative must be in writing 
and must:
     Identify the specified lots, batches, or other units of 
the affected product;
     Identify the specific labeling provisions under this rule 
that are the subject of the request;
     Explain why compliance with the specified labeling 
provisions could adversely affect the safety, effectiveness, or 
availability of the product subject to the request;
     Describe any proposed safeguards or conditions that will 
be implemented so that the labeling of the product includes appropriate 
information necessary for the safe and effective use of the product 
given the anticipated circumstances of use of the product;
     Provide copies of the proposed labeling of the specified 
lots, batches, or other units of the affected product that will be 
subject to the exception or alternative; and
     Provide any other information requested by the FDA Center 
Director in support of the request.
    If the request is granted, the manufacturer may need to report to 
FDA any resulting changes to the New Drug Application, Biologics 
License Application, Premarket Approval Application, or Premarket 
Notification (510(k)) in effect, if any. The submission and grant of an 
exception or an alternative to the labeling requirements specified in 
this rule may be used to satisfy certain reporting obligations relating 
to changes to product applications under 21 CFR 314.70 (human drugs), 
21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices 
subject to premarket approval), or 21 CFR 807.81 (medical devices 
subject to 510(k) clearance requirements). The information collection 
provisions in Sec. Sec.  314.70, 601.12, 807.81, and 814.39 have been 
approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 
0910-0231 respectively. On a case-by-case basis, the appropriate FDA 
Center Director may also determine when an exception or alternative is 
granted that certain safeguards and conditions are appropriate, such as 
additional labeling on the SNS products, so that the labeling of such 
products would include information needed for safe and effective use 
under the anticipated circumstances of use.
    Respondents to this collection of information are entities that 
manufacture (including labeling, packing, relabeling, or repackaging), 
distribute, or store affected SNS products. Based on the number of 
requests for an exception or alternative received by FDA in fiscal 
years 2012-13, FDA estimates an average of one request annually. FDA 
estimates an average of 24 hours preparing each request. The average 
burden per

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response for each submission is based on the estimated time that it 
takes to prepare a supplement to an application, which may be 
considered similar to a request for an exception or alternative. To the 
extent that labeling changes not already required by FDA regulations 
are made in connection with an exception or alternative granted under 
the final rule, FDA is estimating one occurrence annually in the event 
FDA would require any additional labeling changes not already covered 
by FDA regulations. FDA estimates 8 hours to develop and revise the 
labeling to make such changes. The average burden per response for each 
submission is based on the estimated time to develop and revise the 
labeling to make such changes.
    In the Federal Register of February 18, 2014 (79 FR 9219), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment from the public. 
The comment was not responsive to the comment request on the four 
specified aspects of the collection of information and did not provide 
any data or explanation that would support a change regarding the 
information collection requirements.
    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              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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201.26(b)(1)(i),                               1               1               1              24              24
 610.68(b)(1)(i),
 801.128(b)(1)(i), and
 809.11(b)(1)(i)................
201.26(b)(1)(i),                               1               1               1               8               8
 610.68(b)(1)(i),
 801.128(b)(1)(i), and
 809.11(b)(1)(i)................
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    Total.......................  ..............  ..............  ..............  ..............              32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16589 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P


