Proposed Information Collection Activity; Administration for Native Americans (ANA) Ongoing Progress Report (OPR) and Objective Work Plan (OWP), 35935-35936 [2020-12739]
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Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15-minute unscheduled open
public session for any attendee to
address issues specific to the topics
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
CMS’ Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
online at https://www.cms.gov/apps/
events/upcomingevents.asp?strOrder
By=1&type=3 or by phone by contacting
the person listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice by the deadline listed in the
DATES section of this notice. Please
provide your full name (as it appears on
your state-issued driver’s license),
address, organization, telephone
number(s), and email address. You will
receive a registration confirmation with
instructions for your participation at the
virtual public meeting.
IV. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35).
The Acting Director for the Center for
Clinical Standards and Quality, at the
Centers for Medicare & Medicaid
Services, Jean Moody-Williams, having
reviewed and approved this document,
authorizes Evell J. Barco Holland, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Authority: 5 U.S.C. App. 2, section 10(a).
Dated: June 8, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–12720 Filed 6–10–20; 8:45 am]
BILLING CODE 4120–01–P
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Administration for Native
Americans (ANA) Ongoing Progress
Report (OPR) and Objective Work Plan
(OWP)
Administration for Native
Americans, Administration for Children
and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families’ (ACF)
Administration for Native Americans
(ANA) is requesting a revision to the
information collection: Ongoing
Progress Report (OPR) and the Objective
Work Plan (OWP) (OMB #0970–0452).
Changes are proposed to reduce the
burden on the public by combining
ANA’s Annual Data Report (OMB
#0970–0475) with the OPR.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
SUMMARY:
Description: Content changes are
being made to the currently approved
OPR. ANA will continue to use the
currently approved OPR with minimal
changes to the instructions for the
remainder of fiscal year (FY) 2020 and
will use the modified OPR beginning FY
2021. The modified OPR combines
ANA’s Annual Data Report (OMB
#0970–0475) with the OPR. The
information in the OPR is collected on
a semi-annual basis to monitor the
performance of grantees and better
gauge grantee progress.
The OPR information collection is
conducted in accordance with Sec. 811
[42 U.S.C. 2992] of the Native American
Programs Act and will allow ANA to
report quantifiable results across all
program areas. It also provides grantees
with parameters for reporting their
progress and helps ANA better monitor
and determine the effectiveness of their
projects.
There are no changes proposed to the
OWP. The OWP information collection
is conducted in accordance with 42
U.S.C. of the Native American Programs
Act of 1972, as amended. This
collection is necessary to evaluate
applications for financial assistance and
determine the relative merits of the
projects for which such assistance is
requested, as set forth in Sec. 806 [42
U.S.C. 2991d–1](a)(1).
Respondents: Federally and staterecognized tribes, Native Pacific
Islanders, Tribal Colleges and
Universities, native non-profits, and
consortia.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Objective Work Plan ........................................................
Ongoing Progress Report FY 2020 .................................
Ongoing Progress Report FY 2021—Exp. Date .............
Total number of
responses
per respondent
300
200
200
Average
burden hours
per response
1
2
4
3
1
2
Total burden
hours
900
400
1600
Annual burden
hours *
300
133
533
jbell on DSKJLSW7X2PROD with NOTICES
* Burden is annualized over the three year approval period.
Estimated Total Annual Burden
Hours: 966.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
VerDate Sep<11>2014
17:43 Jun 11, 2020
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performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
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and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
E:\FR\FM\12JNN1.SGM
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35936
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 806 [42 U.S.C. 2991d–
1](a)(1) and Sec. 811 [42 U.S.C. 2992].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–12739 Filed 6–11–20; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4533]
Compounding Animal Drugs From
Bulk Drug Substances; Draft Guidance
for Industry; Availability; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that published in
the Federal Register on November 20,
2019. In that notice, FDA requested
comments on the draft guidance for
industry (GFI) #256 entitled
‘‘Compounding Animal Drugs from Bulk
Drug Substances.’’ FDA is taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is further extending the
comment period on the document
published November 20, 2019 (84 FR
64085), which was reopened in a
document published February 20, 2020
(85 FR 9783). Submit either electronic
or written comments on the draft
guidance by October 15, 2020, to ensure
that the Agency considers your
comments on this draft guidance before
it begins work on the final version of the
guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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
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17:43 Jun 11, 2020
Jkt 250001
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–
2018–D–4533 for ‘‘Compounding
Animal Drugs From Bulk Drug
Substances.’’ 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 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
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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.
Eric
Nelson, Division of Compliance (HFV–
230), Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
402–7001, cvmcompliance@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of November 20, 2019,
FDA published a notice announcing the
availability of draft GFI #256 entitled
‘‘Compounding Animal Drugs From
Bulk Drug Substances’’ with a 90-day
comment period. We requested
comments on the draft guidance with
respect to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment option exists.
Interested persons were originally
given until February 18, 2020, to
comment on the draft guidance. The
Agency received requests to allow
interested persons additional time to
comment. The requests conveyed
concern that the initial 90-day comment
period did not allow sufficient time to
develop a comprehensive response.
FDA considered these requests and
reopened the comment period for an
additional 120 days, until June 17, 2020
(85 FR 9783).
Since then, FDA has received
additional requests to further extend the
comment period. FDA has considered
the requests and is extending the
comment period for the notice of
availability for another 120 days, until
October 15, 2020. The Agency believes
that a further extension of 120 days
allows adequate time for interested
persons to submit comments.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12JNN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35935-35936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12739]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Administration for
Native Americans (ANA) Ongoing Progress Report (OPR) and Objective Work
Plan (OWP)
AGENCY: Administration for Native Americans, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families' (ACF)
Administration for Native Americans (ANA) is requesting a revision to
the information collection: Ongoing Progress Report (OPR) and the
Objective Work Plan (OWP) (OMB #0970-0452). Changes are proposed to
reduce the burden on the public by combining ANA's Annual Data Report
(OMB #0970-0475) with the OPR.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, ACF is soliciting public comment on the specific aspects
of the information collection described above.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be forwarded by emailing
[email protected]. Alternatively, copies can also be obtained
by writing to the Administration for Children and Families, Office of
Planning, Research, and Evaluation (OPRE), 330 C Street SW, Washington,
DC 20201, Attn: ACF Reports Clearance Officer. All requests, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Content changes are being made to the currently
approved OPR. ANA will continue to use the currently approved OPR with
minimal changes to the instructions for the remainder of fiscal year
(FY) 2020 and will use the modified OPR beginning FY 2021. The modified
OPR combines ANA's Annual Data Report (OMB #0970-0475) with the OPR.
The information in the OPR is collected on a semi-annual basis to
monitor the performance of grantees and better gauge grantee progress.
The OPR information collection is conducted in accordance with Sec.
811 [42 U.S.C. 2992] of the Native American Programs Act and will allow
ANA to report quantifiable results across all program areas. It also
provides grantees with parameters for reporting their progress and
helps ANA better monitor and determine the effectiveness of their
projects.
There are no changes proposed to the OWP. The OWP information
collection is conducted in accordance with 42 U.S.C. of the Native
American Programs Act of 1972, as amended. This collection is necessary
to evaluate applications for financial assistance and determine the
relative merits of the projects for which such assistance is requested,
as set forth in Sec. 806 [42 U.S.C. 2991d-1](a)(1).
Respondents: Federally and state-recognized tribes, Native Pacific
Islanders, Tribal Colleges and Universities, native non-profits, and
consortia.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number of Average
Instrument Total number responses per burden hours Total burden Annual burden
of respondents respondent per response hours hours *
----------------------------------------------------------------------------------------------------------------
Objective Work Plan........... 300 1 3 900 300
Ongoing Progress Report FY 200 2 1 400 133
2020.........................
Ongoing Progress Report FY 200 4 2 1600 533
2021--Exp. Date..............
----------------------------------------------------------------------------------------------------------------
* Burden is annualized over the three year approval period.
Estimated Total Annual Burden Hours: 966.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information
[[Page 35936]]
technology. Consideration will be given to comments and suggestions
submitted within 60 days of this publication.
Authority: Sec. 806 [42 U.S.C. 2991d-1](a)(1) and Sec. 811 [42
U.S.C. 2992].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-12739 Filed 6-11-20; 8:45 am]
BILLING CODE 4184-34-P
