Single-Source Supplement for Title X Services in Texas, 70852-70853 [2021-26850]
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70852
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
guidance finalizes the guidance issued
on May 27, 2020.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Q3C(R8)
Impurities: Guidance for Residual
Solvents.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 58 have been
approved under OMB control number
0910–0119.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26889 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1287]
Actavis LLC, et al.; Withdrawal of
Approval of Six Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
khammond on DSKJM1Z7X2PROD with NOTICES
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
Application No.
Drug
ANDA 202603 ...........
Methoxsalen Capsules, 10 milligrams (mg) ...........
ANDA 205274 ...........
Amoxicillin Tablets, 125 mg and 250 mg ...............
ANDA 205513 ...........
Carisoprodol Tablets, 250 mg and 350 mg ............
ANDA 206410 ...........
ANDA 207536 ...........
ANDA 208227 ...........
Itraconazole Capsules, 100 mg ..............................
Flucytosine Capsules, 250 mg and 500 mg ...........
Dutasteride Capsules, 0.5 mg ................................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 12,
2022. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on January 12,
2022, may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
Approval is withdrawn as of
January 12, 2022.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Applicant
Actavis LLC, (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
Hikma Pharmaceuticals LLC, 1809 Wilson Rd., Columbus, OH
43228.
Strides Pharma Global Pte. Limited, U.S. Agent, Strides Pharma
Inc., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ
08816.
Do.
Do.
Do.
expiration dates or otherwise become
violative, whichever occurs first.
Dated: December 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26892 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Single-Source Supplement for Title X
Services in Texas
Office of Population Affairs,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services (HHS).
AGENCY:
PO 00000
withdrawing approval of six abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
Frm 00039
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ACTION:
Notice.
The Office of Population
Affairs (OPA) announces the award of a
single-source supplement to provide
Title X family planning services in
Texas to Women’s Health and Family
Planning Association of Texas (d.b.a.
Every Body Texas). The supplement
will enable Every Body Texas to expand
provision of emergency contraception
and other family planning services to
clients across the state of Texas to
address the anticipated increased
demand for family planning services
following passage of TX SB8.
DATES: December 13, 2021.
FOR FURTHER INFORMATION CONTACT:
Jessica Swafford Marcella, Deputy
Assistant Secretary for Population
SUMMARY:
E:\FR\FM\13DEN1.SGM
13DEN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
Affairs, Office of Population Affairs,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services at Jessica.marcella@
hhs.gov and 240–453–2800.
SUPPLEMENTARY INFORMATION:
Recipient: Every Body Texas, Austin,
TX.
Purpose of the Award: The purpose of
this award is to address the anticipated
need for family planning services across
the state of Texas in response to TX
SB8. With this funding, Every Body
Texas will expand the provision of
emergency contraception and other
family planning services to clients
across the state of Texas through their
existing Title X network.
Amount of Award: $750,000.
Project Period: The project period for
the supplemental award will not exceed
the recipient’s current project period,
which is scheduled to end on March 31,
2022.
OPA currently provides $15,820,000
in Title X funding to Every Body Texas.
With their Title X funding, Every Body
Texas provides Title X family planning
services across Texas through a network
of 36 subrecipients and 192 service
sites. In 2019, Every Body Texas
provided family planning services to
176,697 clients across the State of
Texas.
Supplemental funding will enable
Every Body Texas to expand provision
of emergency contraception and other
family planning services to clients
across the state of Texas through their
existing Title X network, in response to
TX SB8. Title X family planning
services are services that assist in
preventing or achieving pregnancy. Title
X clinics must provide a broad range of
acceptable and effective family planning
methods and services, including:
Contraceptive education, counseling,
and methods (includes hormonal
methods; fertility awareness-based
methods; barrier methods; abstinence;
and/or permanent sterilization); services
centered around pre-conception health
and achieving pregnancy (includes
infertility services; STI prevention,
education, screening, and treatment;
HIV testing and referral); and pregnancy
diagnosis and counseling. The broad
range of family planning services does
not include abortion as a method of
family planning.
This award is being made noncompetitively because Every Body
Texas is the only existing Title X
grantee providing services across the
entire state of Texas. Issuing a singlesource supplemental award to Every
Body Texas would expand services
across the entire state.
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
Dated: November 30, 2021.
Jessica Swafford Marcella,
Deputy Assistant Secretary for Population
Affairs, Office of Population Affairs, Office
of the Assistant Secretary for Health.
[FR Doc. 2021–26850 Filed 12–10–21; 8:45 am]
BILLING CODE 4150–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions (OMB No.
0917–0028)
Indian Health Service, HHS.
Notice and request for
comments; request for extension of
approval.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to take this opportunity
to comment on the information
collection titled, ‘‘Addendum to
Declaration for Federal Employment,
Child Care and Indian Child Care
Worker Positions,’’ Office of
Management and Budget (OMB) Control
Number 0917–0028. A copy of the
supporting statement is available at
www.regulations.gov (see Docket ID:
IHS_FRDOC_0001).
DATES: February 11, 2022. Your
comments regarding this information
collection are best assured of having full
effect if received within 60 days of the
date of this publication.
For Comments: Submit comments to
Sharon Duran by one of the following
methods:
• Email: Sharon.Duran@ihs.gov.
Comments submitted in response to
this notice will be made available to the
public by publishing them in the 30-day
Federal Register notice for this
information collection. For this reason,
please do not include information of a
confidential nature, such as sensitive
personal information or proprietary
information. If comments are submitted
via email, the email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
internet. Please note that responses to
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
SUMMARY:
PO 00000
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70853
To
request additional information, please
contact Evonne Bennett, Information
Collection Clearance Officer at:
Evonne.Bennett@ihs.gov or 301–443–
4750.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register on November 27,
2018, and allowed 30 days for public
comment. No public comment was
received in response to the notice. This
notice announces our intent to submit
this collection, which expires February
28, 2022, to OMB for approval of an
extension, and to solicit comments on
specific aspects for the proposed
information collection.
Title: Addendum to Declaration for
Federal Employment, Child Care and
Indian Child Care Worker Positions
(OMB No. 0917–0028). Type of
Information Collection Request:
Extension, without revision, of currently
approved information collection, 0917–
0028, Addendum to Declaration for
Federal Employment, Child Care and
Indian Child Care Worker Positions.
There are no program changes or
adjustments in burden hours. Form(s):
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions. Need and
Use of Information Collection: This is a
request for approval of the collection of
information as required by section 408
of the Indian Child Protection and
Family Violence Prevention Act, Public
Law 101–630 [104 stat. 4544, 25 U.S.C.
3201–3210]; 34 U.S.C. 20351; and 42
CFR part 136, subpart K.
The IHS is required to compile a list
of all authorized positions within the
IHS where the duties and
responsibilities involve regular contact
with, or control over, Indian children;
and to conduct an investigation of the
character of each individual who is
employed, or is being considered for
employment, in a position having
regular contact with, or control over,
Indian children. 25 U.S.C. 3207(a)(1)
and (2). Section 3207(a)(3) of Title 25
requires regulations prescribing the
minimum standards of character for
individuals appointed to positions
involving regular contact with, or
control over, Indian children, and
section 3207(b) provides that such
standards shall ensure that no such
individuals have been found guilty of,
or entered a plea of nolo contendere or
guilty to, any felonious offense, or any
two or more misdemeanor offenses,
under Federal, State, or Tribal law
involving crimes of violence; sexual
assault, molestation, exploitation,
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\13DEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70852-70853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26850]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Single-Source Supplement for Title X Services in Texas
AGENCY: Office of Population Affairs, Office of the Assistant Secretary
for Health, Office of the Secretary, Department of Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of Population Affairs (OPA) announces the award of
a single-source supplement to provide Title X family planning services
in Texas to Women's Health and Family Planning Association of Texas
(d.b.a. Every Body Texas). The supplement will enable Every Body Texas
to expand provision of emergency contraception and other family
planning services to clients across the state of Texas to address the
anticipated increased demand for family planning services following
passage of TX SB8.
DATES: December 13, 2021.
FOR FURTHER INFORMATION CONTACT: Jessica Swafford Marcella, Deputy
Assistant Secretary for Population
[[Page 70853]]
Affairs, Office of Population Affairs, Office of the Assistant
Secretary for Health, Department of Health and Human Services at
[email protected] and 240-453-2800.
SUPPLEMENTARY INFORMATION:
Recipient: Every Body Texas, Austin, TX.
Purpose of the Award: The purpose of this award is to address the
anticipated need for family planning services across the state of Texas
in response to TX SB8. With this funding, Every Body Texas will expand
the provision of emergency contraception and other family planning
services to clients across the state of Texas through their existing
Title X network.
Amount of Award: $750,000.
Project Period: The project period for the supplemental award will
not exceed the recipient's current project period, which is scheduled
to end on March 31, 2022.
OPA currently provides $15,820,000 in Title X funding to Every Body
Texas. With their Title X funding, Every Body Texas provides Title X
family planning services across Texas through a network of 36
subrecipients and 192 service sites. In 2019, Every Body Texas provided
family planning services to 176,697 clients across the State of Texas.
Supplemental funding will enable Every Body Texas to expand
provision of emergency contraception and other family planning services
to clients across the state of Texas through their existing Title X
network, in response to TX SB8. Title X family planning services are
services that assist in preventing or achieving pregnancy. Title X
clinics must provide a broad range of acceptable and effective family
planning methods and services, including: Contraceptive education,
counseling, and methods (includes hormonal methods; fertility
awareness-based methods; barrier methods; abstinence; and/or permanent
sterilization); services centered around pre-conception health and
achieving pregnancy (includes infertility services; STI prevention,
education, screening, and treatment; HIV testing and referral); and
pregnancy diagnosis and counseling. The broad range of family planning
services does not include abortion as a method of family planning.
This award is being made non-competitively because Every Body Texas
is the only existing Title X grantee providing services across the
entire state of Texas. Issuing a single-source supplemental award to
Every Body Texas would expand services across the entire state.
Dated: November 30, 2021.
Jessica Swafford Marcella,
Deputy Assistant Secretary for Population Affairs, Office of Population
Affairs, Office of the Assistant Secretary for Health.
[FR Doc. 2021-26850 Filed 12-10-21; 8:45 am]
BILLING CODE 4150-30-P
