Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile, 39914-39917 [2020-14267]
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
FDA 2915 entitled ‘‘Radioactive Drug
Research Committee Report on Research
Use of Radioactive Drugs Study
Summary.’’
Under § 361.1(d)(5), each investigator
will obtain the proper consent required
under the regulations. Each female
research subject of childbearing
potential must state in writing that she
is not pregnant or, based on a pregnancy
test, be confirmed as not pregnant.
Under § 361.1(d)(8), the investigator
will immediately report to the RDRC all
adverse effects associated with use of
the drug, and the committee will then
report to FDA all adverse reactions
probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
reporting burden estimate because they
are information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Types of research studies not
permitted under the regulations are also
specified and include those intended for
immediate therapeutic, diagnostic, or
similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an
investigational new drug application
under 21 CFR part 312, and the
associated information collections are
covered in OMB control number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks. Respondents to
this information collection are the
chairperson or chairpersons of each
individual RDRC, investigators, and
participants in the studies. The burden
estimates are based on our experience
with these reporting and recordkeeping
requirements and the number of
submissions we received under the
regulations over the past 3 years.
In the Federal Register of January 21,
2020 (85 FR 3390), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR section and applicable form
§ 361.1(c)(3) reports and (c)(4) approval (Form FDA
2914: Membership Summary) 3.
§ 361.1(c)(3) reports (Form FDA 2915: Study Summary) 4.
§ 361.1(d)(8) adverse events .........................................
Total ........................................................................
Number of
responses per
respondent
Total
annual
responses
Average burden
per response
Total hours
62
1
62
1 ..........................
62
40
10
434
3.5 .......................
1,519
10
1
10
.5 (30 minutes) ....
5
........................
........................
506
.............................
1,586
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers may not sum due to rounding.
3 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
4 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
Number of
records per
recordkeepers
§ 361.1(c)(2) RDRC ........................................................
§ 361.1(d)(5) human research subjects .........................
62
40
4
10
248
434
10 ........................
.75 (45 minutes) ..
2,480
326
Total ........................................................................
........................
........................
682
.............................
2,806
21 CFR section
1 There
Total
annual
responses
Average
burden per
recordkeeping
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
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2 Numbers
We have adjusted our estimate for the
information collection to reflect an
annual decrease of 525 hours and 147
responses since last OMB review. This
adjustment corresponds to fewer
submissions we have received under the
information collection over the last few
years.
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14262 Filed 7–1–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
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
SUMMARY:
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
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
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ACTION:
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
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’’).
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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
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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-201509-18/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
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39915
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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
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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 (§§ 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 §§ 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 §§ 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 §§ 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-bycase 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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201.26(b)(1)(i),
809.11(b)(1)(i)
201.26(b)(1)(i),
809.11(b)(1)(i)
610.68(b)(1)(i), 801.128(b)(1)(i), and
...................................................................
610.68(b)(1)(i), 801.128(b)(1)(i), and
...................................................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
(in hours)
Total
annual
responses
1
1
1
24
24
1
1
1
8
8
........................
........................
........................
........................
32
are no capital costs or operating and maintenance costs associated with this collection of information.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0145]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With Animal Drug and
Animal Generic Drug User Fees
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by August 3,
2020.
SUMMARY:
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 0910–0540. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
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has submitted the following proposed
collection of information to OMB for
review and clearance.
Reporting Associated With Animal
Drug and Animal Generic Drug User
Fees—21 U.S.C. 379j–12 and 379j–21
OMB Control Numbers 0910–0540—
Extension
This information collection supports
FDA’s animal drug and animal generic
drug user fee programs. The Animal
Drug User Fee Act of 2003 (ADUFA)
(Pub. L. 108–130) amended the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) by adding section 740 of the FD&C
Act (21 U.S.C 379j–12), which requires
that FDA assess and collect user fees
with respect to new animal drug
applications for certain applications,
products, establishments, and sponsors.
It also requires the Agency to grant a
waiver from, or a reduction of, those
fees in certain circumstances. The
Animal Generic Drug User Fee Act of
2008 (AGDUFA) (Pub. L. 110–316)
added section 741 of the FD&C Act (21
U.S.C. 379j–21), which establishes three
different kinds of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). On August 14, 2018, H.R. 5554,
the Animal Drug and Animal Generic
Drug User Fee Amendments of 2018,
was signed into law to reauthorize the
ADUFA and AGDUFA programs
administered by FDA.
Sponsors of new animal drug
applications prepare and submit user
fee cover sheets. The Animal Drug User
Fee cover sheet (Form FDA 3546) is
designed to collect the minimum
necessary information to determine
whether a fee is required for the review
of an application or supplement or
whether an application fee waiver was
granted, to determine the amount of the
fee required, and to ensure that each
animal drug user fee payment is
appropriately linked to the animal drug
application for which payment is made.
The form, when completed
electronically, results in the generation
of a unique payment identification
number used by FDA to track the
payment. The information collected is
used by FDA’s Center for Veterinary
Medicine (CVM) to initiate the
administrative screening of new animal
drug applications and supplements. The
information collection associated with
the Animal Drug User Fee cover sheet
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39917
currently is approved under OMB
control number 0910–0539.
Sponsors of abbreviated new animal
drug applications also prepare and
submit user fee cover sheets. The
Animal Generic Drug User Fee cover
sheet (Form FDA 3728) similarly is
designed to collect the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to ensure that
each animal generic drug user fee
payment is appropriately linked to the
abbreviated new animal drug
application for which payment is made.
The form, when completed
electronically, results in the generation
of a unique payment identification
number used by FDA to track the
payment. The information collected is
used by CVM to initiate the
administrative screening of abbreviated
new animal drug applications. The
information collection associated with
the Animal Generic Drug User Fee cover
sheet currently is approved under OMB
control number 0910–0632.
FDA has also developed a guidance
for industry (GFI) #170 entitled ‘‘Animal
Drug User Fees and Fee Waivers and
Reductions.’’ This guidance provides
guidance on the types of fees FDA is
authorized to collect under section 740
of the FD&C Act, and how to request
waivers and reductions from these fees.
Further, this guidance also describes
what information FDA recommends be
submitted in support of a request for a
fee waiver or reduction; how to submit
such a request; and FDA’s process for
reviewing requests. FDA uses the
information submitted by respondents
to determine whether to grant the
requested fee waiver or reduction. The
information collection associated with
GFI #170 currently is approved under
OMB control number 0910–0540.
The information collection provisions
approved under OMB control numbers
0910–0539, 0910–0540, and 0910–0632
are similar in that they support FDA’s
animal drug and animal generic drug
user fee programs. Thus, with this
notice, FDA proposes to consolidate
these collections of information into one
OMB control number for government
efficiency and to allow the public to
look to one OMB control number for all
reporting associated with FDA’s animal
drug and animal generic drug user fee
programs. Because we are proposing to
combine all reporting associated with
FDA’s animal drug user fees into one
collection, we are consolidating the
burden under OMB control number
0910–0540 and discontinuing OMB
control numbers 0910–0539 and 0910–
0632.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
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)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 32
----------------------------------------------------------------------------------------------------------------
\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
