
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9219-9220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03382]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]


Agency Information Collection Activities; Proposed Collection; 
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 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, 
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 related to the exceptions or alternatives to labeling 
requirements for products held by the Strategic National Stockpile 
(SNS).

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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, 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 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.

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

[[Page 9220]]

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

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of        Number of responses      Total annual       Average burden per
              21 CFR Section                     respondents         per respondent           responses             response             Total hours
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201.26(b)(1)(i), 610.68(b)(1)(i),                              1                     1                     1                    24                    24
 801.128(b)(1)(i), and 809.11(b)(1)(i)....
201.26(b)(1)(i), 610.68(b)(1)(i),                              1                     1                     1                     8                     8
 801.128(b)(1)(i), and 809.11(b)(1)(i)....
    Total.................................                    32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 11, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-03382 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P


