Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Targeted Mechanism of Action Presentations in Prescription Drug Promotion, 76492 [2022-27140]

Download as PDF 76492 Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Notices hearing and waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. David J. Kempema has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Mr. Kempema is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Kempema is a prohibited act. Any application by Mr. Kempema for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2022– N–0521 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Dated: December 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ‘‘Targeted Mechanism of Action Presentations in Prescription Drug Promotion’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On October 14, 2022, the Agency submitted a proposed collection of information entitled ‘‘Targeted Mechanism of Action Presentations in Prescription Drug Promotion’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0908. The approval expires on November 30, 2025. A copy of the supporting statement for this information collection is available on the internet at https:// www.reginfo.gov/public/do/PRAMain. SUMMARY: Dated: December 9, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27140 Filed 12–13–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2969] [FR Doc. 2022–27091 Filed 12–13–22; 8:45 am] Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration ACTION: Food and Drug Administration, HHS. Notice; renewal of Federal advisory committee. [Docket No. FDA–2021–N–1050] The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic 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 Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Targeted Mechanism of Action Presentations in Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:11 Dec 13, 2022 Jkt 259001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 new charter will be in effect until the August 27, 2024, expiration date. DATES: Authority for the Endocrinologic and Metabolic 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: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–2855, EMDAC@fda.hhs.gov. 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 Endocrinologic and Metabolic 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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic 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 endocrinology, metabolism, epidemiology or statistics, and related specialties. 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 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 E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Page 76492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1050]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Targeted Mechanism of Action 
Presentations in Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a collection of information entitled ``Targeted Mechanism of 
Action Presentations in Prescription Drug Promotion'' has been approved 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA).

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
P[email protected].

SUPPLEMENTARY INFORMATION: On October 14, 2022, the Agency submitted a 
proposed collection of information entitled ``Targeted Mechanism of 
Action Presentations in Prescription Drug Promotion'' to OMB for review 
and clearance under 44 U.S.C. 3507. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0908. The approval expires on November 30, 2025. A 
copy of the supporting statement for this information collection is 
available on the internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27140 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P

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