Proposed Information Collection Activity; Comment Request, 1468-1469 [2019-00895]
Download as PDF
<![CDATA[
1468
Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices
sent by U.S. mail, they should be
addressed to Office of Information and
Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for the Federal Trade
Commission, New Executive Office
Building, Docket Library, Room 10102,
725 17th Street NW, Washington, DC
20503. Comments sent to OMB by U.S.
postal mail, however, are subject to
delays due to heightened security
precautions. Thus, comments instead
can also be sent by email to wliberante@
omb.eop.gov.
Heather Hippsley,
Deputy General Counsel.
[FR Doc. 2019–00904 Filed 2–1–19; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0215]
Submission for OMB Review;
Comment Request
Title: Tribal TANF Data Report, TANF
Annual Report, and Reasonable Cause/
Corrective Action Documentation
Process–Final
Description: 42 U.S.C. 612 (Section
412 of the Social Security Act as
amended by Public Law 104–193, the
Personal Responsibility and Work
Opportunity Reconciliation Act of 1996
(PRWORA)), mandates that federally
recognized Indian Tribes with an
approved Tribal TANF program collect
and submit to the Secretary of the
Department of Health and Human
Services data on the recipients served
by the Tribes’ programs. This
information includes both aggregated
and disaggregated data on case
characteristics and individual
characteristics. In addition, Tribes that
are subject to a penalty are allowed to
provide reasonable cause justifications
as to why a penalty should not be
imposed or may develop and implement
corrective compliance procedures to
eliminate the source of the penalty.
Finally, there is an annual report, which
requires the Tribes to describe program
characteristics. All of the above
requirements are currently approved by
OMB and the Administration for
Children and Families is simply
proposing to extend them without any
changes.
Respondents: Federally recognized
Indian tribes
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
amozie on DSK3GDR082PROD with NOTICES1
FINAL tribal TANF report .................................................................................
Tribal TANF Annual Report .............................................................................
Tribal TANF reasonable cause/corrective .......................................................
Estimated Total Annual Burden
Hours: 140,896.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning 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. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–00808 Filed 2–1–19; 8:45 am]
BILLING CODE 4184–36–P
VerDate Sep<11>2014
17:21 Feb 01, 2019
Jkt 247001
74
74
74
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Prevention Services Data
Collection.
OMB No.: 0970–NEW.
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
the Administration for Children and
Families (ACF) information on children
receiving prevention and family services
and programs. States and tribes must
report:
• 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 12
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
Average
burden
hours per
response
4
1
1
451
40
60
Total
burden
hours
133,496
2,960
4,440
month 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.
It is anticipated that half or less of the
tribes and states will choose to provide
these prevention services in the first
years of the program availability, but
that number will increase over time.
The data collected will 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 will
contain personally identifiable
information (date of birth and race/
ethnicity).
Respondents: State and tribal child
welfare agencies.
E:\FR\FM\04FEN1.SGM
04FEN1
1469
Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden
hours
Prevention Services Data Collection ...............................................................
20
1
31
620
Estimated Total Annual Burden
Hours: 620.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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 technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–00895 Filed 2–1–19; 8:45 am]
BILLING CODE 4184–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket Nos. FDA–2018–P–1877 and FDA–
2018–P–3730]
Determination That ESBRIET
(Pirfenidone) Film Coated Tablets, 534
Milligrams, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:21 Feb 01, 2019
Jkt 247001
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ESBRIET (pirfenidone),
film coated tablets, 534 milligrams (mg),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for pirfenidone,
film coated tablets, 534 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 301–
796–6650.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ESBRIET (pirfenidone), film coated
tablets, 534 mg, is the subject of NDA
208780, held by Genentech, Inc., and
initially approved on January 11, 2017.
ESBRIET is indicated for the treatment
of idiopathic pulmonary fibrosis.
ESBRIET (pirfenidone), film coated
tablets, 534 mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Laurus Labs
Ltd. submitted a citizen petition dated
May 14, 2018 (Docket No. FDA–2018–
P–1877), and Aziant Drug Research
Solutions Pvt. Ltd. Submitted a citizen
petition dated October 1, 2018 (FDA–
2018–P–3730), under 21 CFR 10.30,
requesting that the Agency determine
whether ESBRIET (pirfenidone), film
coated tablets, 534 mg, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ESBRIET (pirfenidone),
film coated tablets, 534 mg, was not
withdrawn for reasons of safety or
effectiveness. The petitioners have
identified no data or other information
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ESBRIET
(pirfenidone), film coated tablets, 534
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ESBRIET (pirfenidone),
film coated tablets, 534 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
E:\FR\FM\04FEN1.SGM
04FEN1
]]>Agencies
[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1468-1469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Prevention Services Data Collection.
OMB No.: 0970-NEW.
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 the
Administration for Children and Families (ACF) information on children
receiving prevention and family services and programs. States and
tribes must report:
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.
It is anticipated that half or less of the tribes and states will
choose to provide these prevention services in the first years of the
program availability, but that number will increase over time.
The data collected will 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 will contain personally identifiable
information (date of birth and race/ethnicity).
Respondents: State and tribal child welfare agencies.
[[Page 1469]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Prevention Services Data Collection......... 20 1 31 620
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 620.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for
Children and Families is soliciting public comment on the specific
aspects of the information collection described above. Copies of the
proposed collection of information can be obtained and comments may be
forwarded by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
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 technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-00895 Filed 2-1-19; 8:45 am]
BILLING CODE 4184-25-P
