Animal Generic Drug User Fee Act; Public Meeting; Request for Comments; Extension of Comment Period, 63782-63783 [2022-22744]
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Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices
consultation with existing grant
recipients and stakeholders, to reduce
respondent burden and strengthen
privacy and confidentiality.
Specifically, to reduce burden and
strengthen client privacy and
confidentiality, the following DVHT
client-level indicators have been
removed: Type of Intake, Date of Birth,
Services Requested at Intake, Benefits
Requested at Intake, Trafficker
Relationship to Victim, and
Employment Status at Case Closure. To
reduce respondent burden, additional
outreach and subrecipient indicators
have also been removed: Screening Tool
Used During Outreach, Goal of
Subrecipient Partnership, Type of
Subrecipient Partnership; Services
Provided by Subrecipient (In-House)
and Services Provided by Subrecipient
(by Referral) have been collapsed into
one category: Services Provided By
Subrecipient. A currently approved
form under this collection, the DVHT
Spending Form, was renamed to
Categories of Assistance and categories
of assistance on the Spending Form
have been simplified to reduce reporting
burden. This form was inadvertently not
included on the Federal Register Notice
inviting initial comments on this
collection (87 FR 45107) but has been
included for comment here and is
included in the request to OMB.
Respondents: DVHT Program Grant
Recipients and Clients of those
programs, specifically DVHT–SO and
VHT–NC funding recipients.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Client Characteristics and Program Entry ...........................
Client Case Closure .............................................................
Barriers to Service Delivery and Monitoring ........................
Client Service Use and Delivery ..........................................
Victim Outreach ...................................................................
Training ................................................................................
Subrecipient Enrollment .......................................................
Categories of Assistance .....................................................
Estimated Total Annual Burden
Hours: 720.95.
Authority: 22 U.S.C. 7105.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–22757 Filed 10–19–22; 8:45 am]
BILLING CODE 4184–47–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0655]
Animal Generic Drug User Fee Act;
Public Meeting; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is extending the comment period for
the notice announcing a public meeting
and requesting comments that appeared
in the Federal Register of September 30,
2022. In that notice, FDA announced a
public meeting to discuss the proposed
recommendations for the
reauthorization of the Animal Generic
Drug User Fee Act (AGDUFA IV) for
fiscal years 2024 through 2028 and that
the comment period would be open
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:50 Oct 19, 2022
Jkt 259001
Total number
of responses
per
respondent
1,700
1,700
35
1,700
35
35
35
35
1
1
4
1
4
4
3
1
until November 9, 2022. FDA is taking
this action due to a delay in the posting
of the AGDUFA IV Performance Goals
and Procedures Letter. This extension
will provide the public 30 days to
comment as required.
DATES: FDA is extending the comment
period announced in the notice of
public meeting and request for
comments published September 30,
2022 (87 FR 59441). Either electronic or
written comments on the notice must be
submitted by November 14, 2022, to
ensure that the Agency considers your
comments regarding this public meeting
and request for comments.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 14, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Average
burden hours
per response
0.75
0.167
0.167
0.25
0.3
0.5
0.167
.75
Total burden
hours
1,275
283.9
23.4
425
42
70
17.5
26.25
Annual burden
hours
425
94.6
7.8
141.7
14
23.3
5.8
8.75
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–
E:\FR\FM\20OCN1.SGM
20OCN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices
2011–N–0655 for ‘‘Animal Generic Drug
User Fee Act.’’ 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: Lisa
Kable, Center for Veterinary Medicine,
Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240–
402–6888, Lisa.Kable@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 30, 2022,
FDA published a notice announcing a
public meeting and requesting
comments on the proposed
recommendations for the
VerDate Sep<11>2014
16:50 Oct 19, 2022
Jkt 259001
reauthorization of the AGDUFA IV for
fiscal years 2024 through 2028.
Interested persons were originally
given until November 9, 2022, to
comment on the public meeting and
request for comments. Due to a delay in
the posting of the AGDUFA IV
Performance Goals and Procedures
Letter to our website at https://
www.fda.gov/industry/animal-genericdrug-user-fee-act-agdufa/agdufameetings, we are extending the
comment period until November 14,
2022, to allow for a 30-day comment
period.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22744 Filed 10–19–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0401]
Donor Eligibility for Animal Cells,
Tissues, and Cell- and Tissue-Based
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry #254 entitled
‘‘Donor Eligibility for Animal Cells,
Tissues, and Cell- and Tissue-Based
Products.’’ FDA’s Center for Veterinary
Medicine is issuing this guidance for
sponsors, firms, individuals, and
establishments that participate in the
manufacture of, or perform any aspect
of, the donor eligibility determination
for animal cells, tissues, and cell- and
tissue-based products (ACTPs). ACTPs
that are intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease or ACTPs
intended to affect the structure or
function of the animal generally meet
the definition of a new animal drug
under the Federal Food, Drug, and
Cosmetic Act. Donor eligibility is a
critical component of current good
manufacturing practice (CGMP) when
manufacturing ACTPs. A donor should
be considered eligible to donate ACTPs
only if screening of the donor shows
that the donor is free from risk factors
for, and clinical evidence of, infection
with relevant disease agents and
diseases, and the donor (and product/
SUMMARY:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
63783
source material) test results for relevant
disease agents are negative or
nonreactive.
The announcement of the
guidance is published in the Federal
Register on October 20, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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–
2021–D–0401 for ‘‘Donor Eligibility for
Animal Cells, Tissues, and Cell- and
Tissue-Based Products.’’ Received
comments 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
E:\FR\FM\20OCN1.SGM
20OCN1
]]>Agencies
[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63782-63783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22744]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Public Meeting; Request for
Comments; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments; extension of
comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for the notice announcing a public meeting
and requesting comments that appeared in the Federal Register of
September 30, 2022. In that notice, FDA announced a public meeting to
discuss the proposed recommendations for the reauthorization of the
Animal Generic Drug User Fee Act (AGDUFA IV) for fiscal years 2024
through 2028 and that the comment period would be open until November
9, 2022. FDA is taking this action due to a delay in the posting of the
AGDUFA IV Performance Goals and Procedures Letter. This extension will
provide the public 30 days to comment as required.
DATES: FDA is extending the comment period announced in the notice of
public meeting and request for comments published September 30, 2022
(87 FR 59441). Either electronic or written comments on the notice must
be submitted by November 14, 2022, to ensure that the Agency considers
your comments regarding this public meeting and request for comments.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-
[[Page 63783]]
2011-N-0655 for ``Animal Generic Drug User Fee Act.'' 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: Lisa Kable, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-6888, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of September 30,
2022, FDA published a notice announcing a public meeting and requesting
comments on the proposed recommendations for the reauthorization of the
AGDUFA IV for fiscal years 2024 through 2028.
Interested persons were originally given until November 9, 2022, to
comment on the public meeting and request for comments. Due to a delay
in the posting of the AGDUFA IV Performance Goals and Procedures Letter
to our website at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings, we are extending the comment
period until November 14, 2022, to allow for a 30-day comment period.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22744 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P
