Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal, 76197-76198 [2022-27014]
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76197
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
order to comply with the Convention,
the U.S. implements the Convention’s
case processing forms. Newly
incorporated into this information
collection are two additional forms,
Request for Specific Measures and
Request for Specific Measures—
Response, which were approved in June
2022 for use under the Convention. The
other forms remain unchanged.
State and federal law require states to
use federally approved case processing
forms. Section 311(b) of UIFSA 2008,
which has been enacted by all 50 states,
the District of Columbia, Guam, Puerto
Rico, and the Virgin Islands, requires
states to use forms mandated by federal
law. 45 CFR 303.7 also requires child
support programs to use federally
approved forms in intergovernmental
IV–D cases unless a country has
provided alternative forms as a part of
its chapter in a Caseworker’s Guide to
Processing Cases with Foreign
Reciprocating Countries.
Respondents: State agencies
administering a child support program
under title IV–D of the Social Security
Act.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Annex I: Transmittal form under Article 12(2) .................................................
Annex II: Acknowledgment form under Article 12(3) .......................................
Annex A: Application for Recognition and Enforcement, including restricted
information on the applicant .........................................................................
Annex A: Abstract of Decision .........................................................................
Annex A: Statement of Enforceability of Decision ...........................................
Annex A: Statement of Proper Notice .............................................................
Annex A: Status of Application Report—Article 12 .........................................
Annex B: Application for Enforcement of a Decision Made or Recognized in
the Requested State, including restricted information on the applicant ......
Annex B: Status of Application Report—Article 12 .........................................
Annex C: Application for Establishment of a Decision, including restricted
information on the Applicant ........................................................................
Annex C: Status of Application Report—Article 12 .........................................
Annex D: Application for Modification of a Decision, including Restricted Information on the Applicant ...........................................................................
Annex D: Status of Application Report—Article 12 .........................................
Annex E: Financial Circumstances Form ........................................................
Annex F: Request for Specific Measures—Article 7(1) ...................................
Annex F: Request for Specific Measures—Response—Article 7(1) ...............
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–26953 Filed 12–12–22; 8:45 am]
[Docket No. FDA 2022–N–3091]
Advisory Committee; Cardiovascular
and Renal Drugs Advisory Committee;
Renewal
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
SUMMARY:
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
2,214
2,187
54
54
54
54
54
16
4
16
4
34
.5
1
0.17
.5
.33
432
216
147
108
606
54
54
17
33
.5
.33
459
588
54
54
4
8
.5
.33
108
143
54
54
54
54
54
4
8
41
2
8
.5
.33
2
.17
.17
108
143
4,428
18
73
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
1
.5
Authority for the Cardiovascular
and Renal Drugs Advisory Committee
will expire on August 27, 2024 unless
the Commissioner formally determines
that renewal is in the public interest.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, (301) 837–7126,
CRDAC@fda.hhs.gov.
Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Cardiovascular and Renal
Drugs Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Annual
burden hours
41
81
DATES:
BILLING CODE 4184–41–P
Average
burden hours
per response
54
54
determined that it is in the public
interest to renew the Cardiovascular and
Renal Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the August 27, 2024,
expiration date.
Estimated Total Annual Burden
Hours: 11,978.
Authority: 42 U.S.C. 654(20) and
666(f).
Total
number of
responses per
respondent
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
cardiology, hypertension, arrhythmia,
angina, congestive heart failure,
diuresis, and biostatistics. Members will
be invited to serve for overlapping terms
of up to 4 years. Non-Federal members
of this committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
E:\FR\FM\13DEN1.SGM
13DEN1
76198
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
cardiovascular-and-renal-drugsadvisory-committee/cardiovascularand-renal-drugs-advisory-committeecharter or by contacting the Designated
Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the
fact that no change has been made to the
committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27014 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 12,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0312. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect Children
and Adolescents—21 CFR Part 1140
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
OMB Control Number 0910–0312—
Revision
This information collection supports
FDA regulatory requirements contained
in part 1140 (21 CFR part 1140)
authorized under Chapter IX of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 9) and associated Agency
guidance. Regulations in part 1140
establish permissible forms of labeling
and advertising for cigarettes or
smokeless tobacco and include
reporting requirements directing
persons to notify FDA if they intend to
use a form of advertising or labeling that
is not addressed in the regulations.
Section 1140.30(a)(2) (21 CFR
1140.30(a)(2)) requires tobacco product
manufacturers, distributors, and
retailers to notify FDA if they intend to
use advertising or labeling for cigarettes
or smokeless tobacco in a medium that
is not listed in the regulations. The
notifications must be made 30 days
prior to the use of such mediums.
We allow electronic and written
submission of these notifications.
Respondents can mail notifications as
prescribed in section 1140.30(a)(2) to
FDA. Instructions providing
clarification on how to format the
notification may be found in the
guidance document entitled
‘‘Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents’’
(2010) (https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/compliance-regulationsrestricting-sale-and-distributioncigarettes-and-smokeless-tobaccoprotect).
In the Federal Register of June 27,
2022 (87 FR 38160), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited. Subsequent to publication of
the 60-day notice, we identified the
associated guidance as an information
collection instrument.
FDA estimates the burden of this
collection of information as follows:
lotter on DSK11XQN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section/Guidance Document Section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
1140.30(a)(2)—Notification of other advertising or labeling medium ...................
25
1
25
1
25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
submissions regarding cigarette and
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16:56 Dec 12, 2022
Jkt 259001
smokeless tobacco product advertising
expenditures.
FDA estimates that approximately 25
respondents will submit an annual
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
notice of alternative advertising or
labeling, and the Agency has estimated
it should take 1 hour to provide such
notice. Therefore, the total estimated
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76197-76198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27014]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2022-N-3091]
Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Cardiovascular and Renal Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until the August 27, 2024, expiration date.
DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2024 unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (301) 837-7126,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Cardiovascular and
Renal Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as Special Government Employees,
representatives, or Ex-Officio members. Federal members will serve as
Regular Government Employees or Ex-Officios. The core of voting members
may
[[Page 76198]]
include one technically qualified member, selected by the Commissioner
or designee, who is identified with consumer interests and is
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one non-voting representative member who is
identified with industry interests. There may also be an alternate
industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-drugs-advisory-committee-charter or by contacting the Designated
Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the
fact that no change has been made to the committee name or description
of duties, no amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27014 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
