Submission for OMB Review; Prevention Services Data Collection (OMB #0970-0529), 13293-13294 [2022-04939]
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Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices
FOR FURTHER INFORMATION CONTACT:
William Cody, Secretary; Phone: (202)
523–5725; Email: secretary@fmc.gov.
SUPPLEMENTARY INFORMATION: On
December 28, 2021, the Commission
issued three policy statements to
provide guidance to shippers and others
on bringing private party complaints at
the Commission and to address barriers
identified by the trade community as
disincentives to filing actions at the
agency. The Commission voted in
September 2021 to adopt the
recommendation of the Fact Finding
Officer of Fact Finding No. 29:
International Ocean Transportation
Supply Chain Engagement to issue
policy statements on the anti-retaliation
provision of the Shipping Act (46 U.S.C.
41104(a)(3)), the standard for recovering
attorney fees in private party
complaints, and the ability of shippers’
associations and trade associations to
file a complaint with the Commission
alleging a violation of the Shipping Act.
Policy Statement on Representative
Complaints: In the first policy
statement, the Commission restates that
shippers’ associations and trade
associations may file complaints
alleging violations of 46 U.S.C. Chapter
411.
Policy Statement on Attorney Fees:
The second policy statement explains
the Commission’s approach on attorney
fees and reiterates that a party who
brings an unsuccessful complaint is not
automatically required to pay the other
party’s attorney fees.
Policy Statement on Retaliation:
Finally, in the third statement on
retaliation, the Commission emphasizes
that it broadly defines both who can
bring a retaliation complaint, as well as
the types of shipper activity that are
protected under the existing retaliation
prohibitions. This policy statement also
addresses the proof necessary for certain
retaliation complaints.
The policy statements can be found at
the following link: https://www.fmc.gov/
resources-services/filing-a-shipping-actcomplaint/.
By the Commission.
William Cody,
Secretary.
[FR Doc. 2022–04658 Filed 3–8–22; 8:45 am]
BILLING CODE 6730–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Prevention Services Data Collection
(OMB #0970–0529)
Children’s Bureau,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Children’s
Bureau is requesting a 3-year extension
of the Prevention Services Data
Collection (OMB #0970–0529,
expiration 7/31/2022). There are no
changes requested to the form.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Description: Section 471(e)(4)(E) of
the Social Security Act (the Act) (42
U.S.C. 671), as amended by Public Law
115–123, requires state and tribal child
welfare agencies to collect and report to
ACF information on children receiving
prevention and family services and
programs. Title IV–E Agencies must
report the following on a bi-annual
basis:
• The specific services or programs
provided
• The total expenditures for each of the
services or programs provided
• The duration of the services or
programs provided, and
• If the child was identified in a
prevention plan as a candidate for
foster care:
Æ The child’s placement status at the
beginning, and at the end, of the 12month period that begins on the
date the child was identified as a
candidate for foster care in a
prevention plan; and
Æ Whether the child entered foster
care during the initial 12-month
period and during the subsequent
12-month period.
To date, approximately 3⁄4 of the Title
IV–E Agencies have chosen to provide
these prevention services; however, it is
believed that this number will continue
to increase over time as states
voluntarily opt-in to the program in
order to utilize IV–E funding to provide
prevention programs and services to
children and families.
The data collected will continue to
inform federal policy decisions,
program management, and responses to
Congressional and Departmental
inquiries. Specifically, the data will
provide information about the use and
availability of prevention services to
children to prevent the need for foster
care placement. The data contains
personally identifiable information (date
of birth and race/ethnicity).
Respondents: Title IV–E Agencies.
jspears on DSK121TN23PROD with NOTICES1
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden
hours
Prevention Services Data Collection ...............................................................
55
2
31
3,410
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17:44 Mar 08, 2022
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13294
Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices
Estimated Total Annual Burden
Hours: 3,410.
Authority: Section 471(e)(4)(E) of the
Act (42 U.S.C. 671), as amended by
Public Law 115–123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–04939 Filed 3–8–22; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Background
[Docket No. FDA–1977–N–0015 (Formerly
77N–0187); DESI 7663]
Drugs for Human Use; Drug Efficacy
Study Implementation; Potassium
Aminobenzoate Oral Preparations;
Withdrawal of Hearing Request;
Withdrawal of New Drug Application;
Final Resolution of Drug Efficacy
Study Implementation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that all outstanding hearing
requests regarding POTABA (potassium
aminobenzoate) Tablets, Capsules,
Powder, and Envules under Docket No.
FDA–1977–N–0015 (formerly 77N–
0187) (this Drug Efficacy Study
Implementation (DESI) 7663) have been
withdrawn. Therefore, as proposed in
the notice of opportunity for hearing
(NOOH), FDA finds that the products
subject to the application identified in
this docket, or any identical, related, or
similar (IRS) products, have not been
shown to be effective for use under the
conditions of use prescribed,
recommended, or suggested in the
labeling, and hereby withdraws
approval of the application under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: This notice is applicable April 8,
2022.
ADDRESSES: 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
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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The most relevant background
documents regarding this matter are
available in the docket. However,
additional background documents are
available upon request (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Astrid Lopez-Goldberg, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5185,
Silver Spring, MD 20993–0002, 301–
796–3485, email:
Astrid.LopezGoldberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In 1962, Congress amended the FD&C
Act to require that new drugs be proven
effective for their labeled indications, as
well as safe, in order to obtain FDA
approval (Drug Amendments of 1962
(Pub. L. 87–781)). These amendments
also required FDA to conduct a
retrospective evaluation of the
effectiveness of the drug products that
FDA had approved as safe between 1938
and 1962. FDA contracted with the
National Academy of Sciences/National
Research Council (NAS/NRC) to make
an initial evaluation of the effectiveness
of over 3,400 products that had been
approved only for safety between 1938
and 1962. The NAS/NRC reports for
these drug products were submitted to
FDA in the late 1960s and early 1970s.
The Agency reviewed and reevaluated
the reports and published its findings in
Federal Register notices. FDA’s
administrative implementation of the
NAS/NRC reports was called the DESI.
DESI covered the approximately 3,400
products specifically reviewed by the
NAS/NRC, as well as the even larger
number of IRS products that entered the
market without FDA approval. If FDA’s
final DESI determination classifies a
drug product as lacking substantial
evidence of effectiveness for one or
more indications, that drug product and
those IRS to it may no longer be
marketed for such indications and are
subject to enforcement action as
unapproved new drugs.
II. Final Resolution of Hearing Request
Regarding Potassium Aminobenzoate
Oral Preparations Under Docket No.
FDA–1977–N–0015 (Formerly 77N–
0187); DESI 7663
In a Federal Register notice published
on August 28, 1970 (35 FR 13755), FDA
announced its evaluation of a report
received from the NAS/NRC under DESI
7663 regarding POTABA (potassium
aminobenzoate) Tablets, Capsules,
Powder, and Envules, New Drug
Application (NDA) 007663, held by
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Glenwood LLC (formerly known as
Glenwood Laboratories, Inc.), 83
Summit St., Tenafly, NJ 07670 (herein
after ‘‘Glenwood’’). The notice stated
that the drug products were possibly
effective in the treatment of
scleroderma, dermatomyositis,
morphea, linear scleroderma,
pemphigus, and Peyronie’s Disease and
lacked substantial evidence of
effectiveness for the treatment of
rheumatoid arthritis, sarcoidosis, and
pulmonary fibrosis. Glenwood, and any
other person marketing such drug
products without approval, was given
60 days to revise its labeling to delete
those indications for which substantial
evidence of effectiveness was lacking
and 6 months to submit data to provide
substantial evidence of effectiveness for
the indications for which the drug was
regarded as possibly effective. The
notice stated that, at the end of the 6month period, FDA would evaluate the
data to determine whether substantial
evidence of effectiveness had been
provided, and, if it had not, FDA would
initiate the withdrawal of approval of
NDA 007663 under section 505(e) of the
FD&C Act (21 U.S.C. 355(e)).
Glenwood did not submit data to
provide substantial evidence of
effectiveness for the indications for
which the drug was regarded as possibly
effective within the period provided by
the 1970 Federal Register notice, and
the Agency issued a NOOH on the
proposed withdrawal of approval of
NDA 007663 in the Federal Register of
February 4, 1972 (37 FR 2688).
In response to a court order, FDA
published a notice in the Federal
Register on December 14, 1972 (37 FR
26623), which stated that POTABA,
among other drugs, could remain on the
market pending completion of further
scientific studies.
In a Federal Register notice published
on August 19, 1977 (42 FR 41922), the
Agency revoked the exemption granted
in the December 14, 1972, notice
pursuant to which POTABA had
remained on the market pending its
continued study. In a separate NOOH
for DESI 7663, also published in the
Federal Register of August 19, 1977 (42
FR 41921), FDA noted that Glenwood
did not submit data providing
substantial evidence of effectiveness
and that no other person had submitted
data or protocols or expressed an
intention to perform clinical studies on
potassium aminobenzoate. This notice
reclassified the possibly effective
indications to lacking substantial
evidence of effectiveness and proposed
to issue an order under section 505(e) of
the FD&C Act withdrawing approval of
Glenwood’s NDA and all amendments
E:\FR\FM\09MRN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13293-13294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04939]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Prevention Services Data Collection
(OMB #0970-0529)
AGENCY: Children's Bureau, Administration for Children and Families,
HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF), Children's
Bureau is requesting a 3-year extension of the Prevention Services Data
Collection (OMB #0970-0529, expiration 7/31/2022). There are no changes
requested to the form.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. You can
also obtain copies of the proposed collection of information by
emailing.
SUPPLEMENTARY INFORMATION:
Description: Section 471(e)(4)(E) of the Social Security Act (the
Act) (42 U.S.C. 671), as amended by Public Law 115-123, requires state
and tribal child welfare agencies to collect and report to ACF
information on children receiving prevention and family services and
programs. Title IV-E Agencies must report the following on a bi-annual
basis:
The specific services or programs provided
The total expenditures for each of the services or programs
provided
The duration of the services or programs provided, and
If the child was identified in a prevention plan as a
candidate for foster care:
[cir] The child's placement status at the beginning, and at the
end, of the 12-month period that begins on the date the child was
identified as a candidate for foster care in a prevention plan; and
[cir] Whether the child entered foster care during the initial 12-
month period and during the subsequent 12-month period.
To date, approximately \3/4\ of the Title IV-E Agencies have chosen
to provide these prevention services; however, it is believed that this
number will continue to increase over time as states voluntarily opt-in
to the program in order to utilize IV-E funding to provide prevention
programs and services to children and families.
The data collected will continue to inform federal policy
decisions, program management, and responses to Congressional and
Departmental inquiries. Specifically, the data will provide information
about the use and availability of prevention services to children to
prevent the need for foster care placement. The data contains
personally identifiable information (date of birth and race/ethnicity).
Respondents: Title IV-E Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Total number of of responses hours per Annual burden
respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
Prevention Services Data Collection......... 55 2 31 3,410
----------------------------------------------------------------------------------------------------------------
[[Page 13294]]
Estimated Total Annual Burden Hours: 3,410.
Authority: Section 471(e)(4)(E) of the Act (42 U.S.C. 671), as
amended by Public Law 115-123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022-04939 Filed 3-8-22; 8:45 am]
BILLING CODE 4184-29-P
