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, 70180-70181 [2020-24427]
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70180
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Current (through January 31, 2021) ..............
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Revised ...........................................................
Total number
of responses
per respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
50
1
90
4,500
* 1,500
50
3
140
21,000
7,000
* Burden is annualized over the full 3-year request period, but this form will be complete within the 1st year.
Estimated Total Annual Burden
Hours: 8,500.
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.
Authority: 8 U.S.C. 412(a)(3).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24398 Filed 11–3–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
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.
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).
SUMMARY:
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.
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:16 Nov 03, 2020
Jkt 253001
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 §§ 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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
E:\FR\FM\04NON1.SGM
04NON1
70181
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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, 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
§§ 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
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
Average
burden
per response
(in hours)
Total annual
responses
Total hours
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.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR Section
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
[FR Doc. 2020–24427 Filed 11–3–20; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration,
Notice.
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.
SUMMARY:
VerDate Sep<11>2014
18:16 Nov 03, 2020
Jkt 253001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 0910–0697. Also include
the FDA docket number found in
brackets in the heading of this
document.
DATES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in 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.
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
