[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39914-39917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14267]


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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, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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

[[Page 39915]]

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 August 31, 2020.

ADDRESSES: You may submit comments as follows: Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 31, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 31, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0588 for ``Exceptions or Alternatives to Labeling 
Requirements for Products Held by the Strategic National Stockpile.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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

[[Page 39916]]

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 21 CFR 201.26, 610.68, 801.128, and 809.11 (Sec. Sec.  
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. Sec.  201.26(b)(1)(i) (human drug products), 
610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical 
devices), and 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 a 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 the 
regulations 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 
the regulations may be used to satisfy certain reporting obligations 
relating to changes to product applications under Sec. Sec.  314.70, 
601.12, 814.39, and 807.81 (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 data from fiscal 
years 2017, 2018, and 2019, FDA estimates an average of one request 
annually for an exception or alternative received by FDA. 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 regulations, 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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                                                                                      Average
                                     Number of       Number of     Total  annual    burden per
         21 CFR section             respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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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.


[[Page 39917]]

    Consistent with the PRA, our current estimate of the burden of the 
information collection is based on our evaluation over the past 3 
years. However, in light of recent consumption of products from the 
SNS, we expect future adjustments may be necessary and invite specific 
comment in this regard.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14267 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P


