[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70180-70181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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: Submit written comments (including recommendations) on the 
collection of information by December 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0614. Also include the FDA docket 
number found in brackets in the heading of this document.

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: 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, 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 Strategic National Stockpile (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. 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

[[Page 70181]]

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, or 807.81 (21 CFR 314.70 (human drugs), 601.12 
(biological products), 814.39 (medical devices subject to premarket 
approval), or 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.
    In the Federal Register of July 2, 2020 (85 FR 39914), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but was not 
responsive to the four information collection topics solicited and is 
therefore not addressed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
         21 CFR Section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in 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.

    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: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24427 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P


