Agency Information Collection Activities; Proposed Collection; Comment Request; Authorization for Medical Products for Use in Emergencies, 12175-12178 [2022-04496]
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Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices
received the proposal and notice of
opportunity for a hearing on November
8, 2021. Mr. Kuiper failed to request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. George
Kuiper has been convicted of felonies
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offenses should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Kuiper is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
applicable (see DATES). Pursuant to
section 301(cc) of the FD&C Act (21
U.S.C. 331(cc)), the importing or
offering for import into the United
States of any drug or controlled
substance by, with the assistance of, or
at the direction of Mr. Kuiper is a
prohibited act.
Any application by Mr. Kuiper for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0665 and sent to the Dockets
Management Staff (see ADDRESSSES).
The public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04484 Filed 3–2–22; 8:45 am]
BILLING CODE 4146–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–N–0918; FDA–
2018–N–1967; FDA–2009–D–0268; and
FDA–2019–N–3077]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
publishing a list of information
collections that have been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
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.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Labeling Requirements for Human Prescription Drug and Biological Products .....................................................
Biosimilar User Fee Program ..................................................................................................................................
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA ...........................................................
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities .................................................................................................................................................
Dated: February 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2022–N–0117]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Authorization for
Medical Products for Use in
Emergencies
Food and Drug Administration,
HHS.
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The Food and Drug
Administration (FDA, Agency, or we) 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
solicits comments on information
collection associated with FDA
Authorization for Medical Products for
Use in Emergencies.
PO 00000
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0910–0572
0910–0718
0910–0728
1/31/2025
1/31/2025
1/31/2025
0910–0883
2/28/2025
Submit either electronic or
written comments on the collection of
information by May 2, 2022.
DATES:
SUMMARY:
[FR Doc. 2022–04409 Filed 3–2–22; 8:45 am]
AGENCY:
Notice.
Date approval
expires
Sfmt 4703
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 May 2, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 2, 2022. 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.
ADDRESSES:
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Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices
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
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–0117 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Authorization for Medical Products for
Use in Emergencies.’’ 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
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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
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,
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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.
Emergency Use Authorization of
Medical Products
OMB Control Number 0910–0595—
Extension
This information collection helps
support implementation of Agency
policies applicable to the authorization
for medical products for use in
emergencies under sections 564, 564A,
and 564B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360bbb–3, 360bbb–3a, and 360bbb–3b).
For more information regarding
emergency use authorization (EUA),
visit our website at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization. The FD&C Act permits
the Commissioner of Food and Drugs
(the Commissioner) to authorize the use
of unapproved medical products, or
unapproved uses of approved medical
products, during an emergency declared
under section 564 of the FD&C Act. The
data to support issuance of an EUA
must demonstrate that, based on the
totality of the scientific evidence
available to the Commissioner,
including data from adequate and wellcontrolled clinical trials (if available), it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing a serious or lifethreatening disease or condition (21
U.S.C. 360bbb–3(c)).
Also under section 564 of the FD&C
Act, the Commissioner may establish
conditions on issuing an authorization
that may be necessary or appropriate to
protect the public health. These
conditions can include requirements to
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disseminate or disclose information to
healthcare providers or authorized
dispensers and product recipients;
adverse event monitoring and reporting;
data collection and analysis; specific
recordkeeping and records access;
restrictions on product advertising,
distribution, and administration; and
limitations on good manufacturing
practice requirements. As governed by
statute, some conditions are mandatory
to the extent practicable for
authorizations of unapproved products,
and discretionary for authorizations of
unapproved uses of approved products.
Some conditions may apply to
manufacturers of an EUA product, while
other conditions may apply to any
person who carries out an activity for
which the authorization is issued.
Sections 564A and 564B of the FD&C
Act establish streamlined mechanisms
intended to facilitate preparedness and
response activities involving certain
FDA approved products without
requiring FDA to issue an EUA, and set
forth emergency dispensing order and
expiration date extension authority.
The guidance document entitled,
‘‘Emergency Use Authorization of
Medical Products and Related
Authorities’’ (January 2017), available
for download from our website at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/emergency-useauthorization-medical-products-andrelated-authorities, discusses FDA
issuance of Emergency Use
Authorizations (EUAs) under section
564 of the FD&C Act; implementation of
the emergency use authorities set forth
in section 564A of the FD&C Act;
reliance on the governmental prepositioning authority set forth in section
564B of the FD&C Act; and related FDA
regulations. As discussed in the
guidance document, the specific type
and amount of data needed to support
an EUA will vary depending on the
nature of the declared emergency and
the nature of the candidate product. The
guidance document encourages early
engagement with FDA, explains
mechanisms for communication, and
makes content and format
recommendations on submitting
information to the Agency. The
guidance document also recommends
that a request for consideration for an
EUA include scientific evidence
evaluating the product’s safety and
effectiveness, including the adverse
event profile for diagnosis, treatment, or
prevention of the serious or lifethreatening disease or condition, as well
as data and other information on safety,
effectiveness, risks and benefits, and (to
the extent available) alternatives.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Requests for a substantive amendment to an existing EUA
Pre-EUA submissions or amendments ................................
Submitting information required under conditions of authorization .........................................................................
State and local public health authority submissions required under conditions of authorization for unapproved
EUA product .....................................................................
State and local public health authority requests for Emergency Dispensing Order ...................................................
State and local public health authority requests for expiration date extension ...........................................................
2,724
2,001
2
1
5,448
2,001
45
34
245,160
68,034
36
3
108
8
864
1
1
1
2
2
1
1
1
2
2
1
1
1
20
20
Total ..............................................................................
........................
........................
7,560
........................
314,082
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Although we have averaged burden
across all respondents, we categorize
reporting activity by the type of EUArelated submission: (1) Those who file a
request for FDA to issue an EUA and/
or a substantive amendment to an EUA
that has previously been issued; (2)
those who submit a request for FDA to
review information/data (i.e., a pre-EUA
package) for a candidate EUA product or
a substantive amendment to an existing
pre-EUA package for preparedness
purposes; (3) those who must report on
activities related to an unapproved EUA
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Number of
responses per
respondent
Number of
respondents
Information collection activity
product (e.g., administering product,
disseminating information) who must
report to FDA regarding such activity;
(4) public health authorities (e.g., State,
local) who must report on certain
activities (e.g., administering product,
disseminating information) related to an
unapproved EUA, and public health
authorities who submit an expiration
date extension request for an approved
product; (5) those who request an
emergency dispensing order under
section 564A; and (6) those who request
expiry dating extensions under section
564A. We attribute greater burden to
those requests for FDA to review preEUA packages submitted by product
sponsors than burden we attribute to
those submitted by Federal agencies
(e.g., Centers for Disease Control and
Prevention, the Department of Defense),
and have considered other factors that
contribute to variability in burden for
reporting, including the type of product
and whether there is a previously
reviewed pre-EUA package or
investigational application.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Records associated with conditions of authorization
Number of
recordkeepers
EUA Holders ........................................................................
State and local Public Health Authorities ............................
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Number of
records per
recordkeeper
648
1
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Total annual
records
2
1
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Average
burden per
recordkeeping
1,296
1
03MRN1
25
3
Total hours
32,400
3
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Records associated with conditions of authorization
Total ..............................................................................
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
........................
........................
Average
burden per
recordkeeping
Total annual
records
1,297
........................
Total hours
32,403
are no capital costs or operating and maintenance costs associated with this collection of information.
We provide a conservative estimate
for respondent recordkeeping,
recognizing that the Federal
Government performs much of this
activity in conjunction with
submissions. We do not include burden
for public health authorities who may
need to submit emergency dispensing
orders or expiration date extension
requests, assuming covered entities
already maintain these records for the
products they stockpile.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Dissemination of required information by EUA Holder or
Authorized Stakeholder ..................................................
1 There
Number of
disclosures per
respondent
Number of
respondents
Information collection activity
I
635
I
2
Total annual
disclosures
I
Total hours
5
6,350
are no capital costs or operating and maintenance costs associated with this collection of information.
Our third-party disclosure estimate is
based on the number of EUA holders
and authorized stakeholders
disseminating information, including
fact sheets, advertising, and promotional
materials.
We have increased our burden
estimate for the information collection
to reflect the increase in submissions we
have received over the last 3 years.
Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04496 Filed 3–2–22; 8:45 am]
For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
SUMMARY:
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I
1,270
Average
burden per
disclosure
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condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
January 1, 2022, through January 31,
2022. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that there is
not a preponderance of the evidence that the
illness, disability, injury, condition, or death
described in the petition is due to factors
unrelated to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability, injury, or
condition not set forth in the Vaccine Injury
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[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12175-12178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0117]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Authorization for Medical Products for Use in
Emergencies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 solicits comments on information collection
associated with FDA Authorization for Medical Products for Use in
Emergencies.
DATES: Submit either electronic or written comments on the collection
of information by May 2, 2022.
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 May 2, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 2, 2022. 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.
[[Page 12176]]
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-2022-N-0117 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Authorization for Medical
Products for Use in Emergencies.'' 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.
Emergency Use Authorization of Medical Products
OMB Control Number 0910-0595--Extension
This information collection helps support implementation of Agency
policies applicable to the authorization for medical products for use
in emergencies under sections 564, 564A, and 564B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3, 360bbb-3a, and
360bbb-3b). For more information regarding emergency use authorization
(EUA), visit our website at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The FD&C Act permits the Commissioner of Food and Drugs
(the Commissioner) to authorize the use of unapproved medical products,
or unapproved uses of approved medical products, during an emergency
declared under section 564 of the FD&C Act. The data to support
issuance of an EUA must demonstrate that, based on the totality of the
scientific evidence available to the Commissioner, including data from
adequate and well-controlled clinical trials (if available), it is
reasonable to believe that the product may be effective in diagnosing,
treating, or preventing a serious or life-threatening disease or
condition (21 U.S.C. 360bbb-3(c)).
Also under section 564 of the FD&C Act, the Commissioner may
establish conditions on issuing an authorization that may be necessary
or appropriate to protect the public health. These conditions can
include requirements to
[[Page 12177]]
disseminate or disclose information to healthcare providers or
authorized dispensers and product recipients; adverse event monitoring
and reporting; data collection and analysis; specific recordkeeping and
records access; restrictions on product advertising, distribution, and
administration; and limitations on good manufacturing practice
requirements. As governed by statute, some conditions are mandatory to
the extent practicable for authorizations of unapproved products, and
discretionary for authorizations of unapproved uses of approved
products. Some conditions may apply to manufacturers of an EUA product,
while other conditions may apply to any person who carries out an
activity for which the authorization is issued. Sections 564A and 564B
of the FD&C Act establish streamlined mechanisms intended to facilitate
preparedness and response activities involving certain FDA approved
products without requiring FDA to issue an EUA, and set forth emergency
dispensing order and expiration date extension authority.
The guidance document entitled, ``Emergency Use Authorization of
Medical Products and Related Authorities'' (January 2017), available
for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities, discusses FDA issuance of
Emergency Use Authorizations (EUAs) under section 564 of the FD&C Act;
implementation of the emergency use authorities set forth in section
564A of the FD&C Act; reliance on the governmental pre-positioning
authority set forth in section 564B of the FD&C Act; and related FDA
regulations. As discussed in the guidance document, the specific type
and amount of data needed to support an EUA will vary depending on the
nature of the declared emergency and the nature of the candidate
product. The guidance document encourages early engagement with FDA,
explains mechanisms for communication, and makes content and format
recommendations on submitting information to the Agency. The guidance
document also recommends that a request for consideration for an EUA
include scientific evidence evaluating the product's safety and
effectiveness, including the adverse event profile for diagnosis,
treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety,
effectiveness, risks and benefits, and (to the extent available)
alternatives.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests for a substantive 2,724 2 5,448 45 245,160
amendment to an existing EUA...
Pre-EUA submissions or 2,001 1 2,001 34 68,034
amendments.....................
Submitting information required 36 3 108 8 864
under conditions of
authorization..................
State and local public health 1 1 1 2 2
authority submissions required
under conditions of
authorization for unapproved
EUA product....................
State and local public health 1 1 1 2 2
authority requests for
Emergency Dispensing Order.....
State and local public health 1 1 1 20 20
authority requests for
expiration date extension......
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Total....................... .............. .............. 7,560 .............. 314,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Although we have averaged burden across all respondents, we
categorize reporting activity by the type of EUA-related submission:
(1) Those who file a request for FDA to issue an EUA and/or a
substantive amendment to an EUA that has previously been issued; (2)
those who submit a request for FDA to review information/data (i.e., a
pre-EUA package) for a candidate EUA product or a substantive amendment
to an existing pre-EUA package for preparedness purposes; (3) those who
must report on activities related to an unapproved EUA product (e.g.,
administering product, disseminating information) who must report to
FDA regarding such activity; (4) public health authorities (e.g.,
State, local) who must report on certain activities (e.g.,
administering product, disseminating information) related to an
unapproved EUA, and public health authorities who submit an expiration
date extension request for an approved product; (5) those who request
an emergency dispensing order under section 564A; and (6) those who
request expiry dating extensions under section 564A. We attribute
greater burden to those requests for FDA to review pre-EUA packages
submitted by product sponsors than burden we attribute to those
submitted by Federal agencies (e.g., Centers for Disease Control and
Prevention, the Department of Defense), and have considered other
factors that contribute to variability in burden for reporting,
including the type of product and whether there is a previously
reviewed pre-EUA package or investigational application.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Records associated with Number of records per Total annual per Total hours
conditions of authorization recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
EUA Holders..................... 648 2 1,296 25 32,400
State and local Public Health 1 1 1 3 3
Authorities....................
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[[Page 12178]]
Total....................... .............. .............. 1,297 .............. 32,403
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We provide a conservative estimate for respondent recordkeeping,
recognizing that the Federal Government performs much of this activity
in conjunction with submissions. We do not include burden for public
health authorities who may need to submit emergency dispensing orders
or expiration date extension requests, assuming covered entities
already maintain these records for the products they stockpile.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissemination of required information by EUA Holder or Authorized 635 2 1,270 5 6,350
Stakeholder......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our third-party disclosure estimate is based on the number of EUA
holders and authorized stakeholders disseminating information,
including fact sheets, advertising, and promotional materials.
We have increased our burden estimate for the information
collection to reflect the increase in submissions we have received over
the last 3 years.
Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04496 Filed 3-2-22; 8:45 am]
BILLING CODE 4164-01-P
