Agency Forms Undergoing Paperwork Reduction Act Review, 33147-33148 [2023-10957]

Download as PDF Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551–0001, not later than June 7, 2023. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Mechanicsville Bancshares, Inc., Mechanicsville, Iowa; to continue to engage in making and servicing loans pursuant to section 225.28(b)(1) of Regulation Y. Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2023–10968 Filed 5–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–23–0920] lotter on DSK11XQN23PROD with NOTICES1 Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ‘‘Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers’’ to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on February 17, 2023 to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; VerDate Sep<11>2014 17:24 May 22, 2023 Jkt 259001 (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers (OMB Control No. 0920–0920, Exp. 05/31/ 2023)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In response to the continued HIV epidemic in our country, in 2009 CDC launched the Let’s Stop HIV Together campaign (formerly known as Act Against AIDS), a multifaceted communication campaign to reduce HIV incidence in the United States. CDC has released the campaign in phases, with some of the phases running concurrently. Each phase of the campaign uses mass media and directto-consumer channels to deliver messages. Some campaigns provide basic education and increase awareness PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 33147 of HIV/AIDS among the general public while others emphasize HIV prevention and testing among specific subgroups or communities at greatest risk of infection. CDC also develops new messages to address changes in prevention science and subpopulations affected by HIV. CDC has used a generic clearance (OMB No. 0920–0920) to facilitate OMB approval of information collection needed to assess the effectiveness of social marketing messages aimed at increasing HIV/AIDS awareness, increasing prevention behaviors, and improving HIV testing rates among consumers. Specifically, in 2022 CDC received OMB approval to collect information for evaluating the acceptability and potential effectiveness of proposed concepts, messages, and taglines for a component of the Let’s Stop HIV Together campaign (‘‘Development of Messages for the Let’s Stop HIV Together National Campaign’’). This component emphasizes proven, effective prevention strategies, such as pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP). Information collection has been initiated but has not been completed. CDC is requesting OMB approval to extend the generic clearance and to complete information collection that supports campaign development and evaluation. Respondents will be recruited through national opt-in email lists, the internet, and external partnerships with community-based and membership organizations that work with or represent individuals from targeted populations (e.g., National Urban League, the National Medical Association). To identify and reach target audiences, screening questions for up to 30,880 potential respondents may address one or more of the following items: Race/ethnicity, sexual behavior, sexual orientation, gender identity, HIV testing history, HIV status, and injection drug use. In addition, up to 5,445 respondents will be asked to complete a self-administered survey at home on a personal computer. Each targeted campaign survey will have a core set of items asked in all rounds, as well as a module of questions relating to specific Let’s Stop HIV Together phases and activities. OMB approval is requested for three years and there is no cost to the respondents other than their time. The total estimated annualized burden is 3,751 hours. E:\FR\FM\23MYN1.SGM 23MYN1 33148 Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Form name Individuals (male and female) aged 18 years and older ........ Study Screener ...................... Survey Module ....................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2023–10957 Filed 5–22–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0687] Abbott Laboratories Pharmaceutical Products Division; Withdrawal of Approval of New Drug Applications for CYLERT (Pemoline) Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams, and CYLERT (Pemoline) Chewable Tablets, 37.5 Milligrams AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 016832 for CYCLERT (pemoline) tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, as well as NDA 017703 for CYCLERT (pemoline) chewable tablets, 37.5 mg, held by Abbott Laboratories Pharmaceutical Products Division, c/o G&L Scientific, 25 Independence Blvd., 4th Floor, Warren, NJ 07059 (Abbott). Abbott requested that approval of these applications be withdrawn and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of May 23, 2023. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 301–796–3137, Kimberly. Lehrfeld@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On January 27, 1975, FDA approved NDA 016832 for CYLERT (pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, for use in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD). On SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Number of respondents Type of respondents VerDate Sep<11>2014 17:24 May 22, 2023 Jkt 259001 January 30, 1976, the Agency approved NDA 017703 for CYLERT (pemoline) chewable tablets, 37.5 mg, for use in the treatment of ADHD. On October 24, 2005, FDA issued a Postmarket Drug Safety Information for Patients and Providers communication entitled ‘‘Information for Healthcare Professionals: Pemoline Tablets and Chewable Tablets (Marketed as CYLERT)’’ which concluded the overall liver toxicity risk of CYLERT (pemoline) (NDAs 016832 and 017703) and generic pemoline products outweighed the benefits of these products (https:// wayback.archive-it.org/7993/ 20171114124349/https://www.fda.gov/ Drugs/DrugSafety/Postmarket DrugSafetyInformationforPatientsand Providers/ucm126461.htm). All holders of approved applications for pemoline products, including Abbott, ceased marketing the products at that time. On April 12, 2021, FDA contacted Abbott and requested the company submit a request for FDA to withdraw approval of NDAs 016832 and 017703 for CYLERT tablets and CYLERT chewable tablets, respectively, pursuant to § 314.150(d) (21 CFR 314.150(d)) due to the risk of liver toxicity. On September 2, 2021, Abbott requested that FDA withdraw approval of CYLERT (pemoline) tablets and CYLERT (pemoline) chewable tablets, NDAs 016832 and 017703, respectively, under § 314.150(d) and waived its opportunity for a hearing. For the reasons discussed above, and in accordance with the applicant’s request, approval of NDAs 016832 and 017703 for CYLERT (pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, and CYLERT (pemoline) chewable tablets, 37.5 mg, respectively, and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of CYLERT (pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, and CYLERT (pemoline) chewable tablets, 37.5 mg, into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a) and 331(d))). PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Number of responses per respondent 30,880 5,445 Average burden per response (in hours) 1 1 2/60 30/60 Dated: May 17, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–10924 Filed 5–22–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Faculty Loan Program—Program Specific Data Form, Annual Performance Report Financial Data Form and NFLP Due Diligence Form; OMB No. 0915–0314– Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30-day comment period for this notice has closed. SUMMARY: Comments on this ICR should be received no later than June 22, 2023. 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 Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Samantha Miller, the HRSA Information DATES: E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Pages 33147-33148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-0920]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Data Collection Through Web Based Surveys 
for Evaluating Act Against AIDS Social Marketing Campaign Phases 
Targeting Consumers'' to the Office of Management and Budget (OMB) for 
review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
February 17, 2023 to obtain comments from the public and affected 
agencies. CDC received two comments related to the previous notice. 
This notice serves to allow an additional 30 days for public and 
affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. 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. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Data Collection Through Web Based Surveys for Evaluating Act 
Against AIDS Social Marketing Campaign Phases Targeting Consumers (OMB 
Control No. 0920-0920, Exp. 05/31/2023)--Extension--National Center for 
HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    In response to the continued HIV epidemic in our country, in 2009 
CDC launched the Let's Stop HIV Together campaign (formerly known as 
Act Against AIDS), a multifaceted communication campaign to reduce HIV 
incidence in the United States. CDC has released the campaign in 
phases, with some of the phases running concurrently. Each phase of the 
campaign uses mass media and direct-to-consumer channels to deliver 
messages. Some campaigns provide basic education and increase awareness 
of HIV/AIDS among the general public while others emphasize HIV 
prevention and testing among specific subgroups or communities at 
greatest risk of infection. CDC also develops new messages to address 
changes in prevention science and subpopulations affected by HIV.
    CDC has used a generic clearance (OMB No. 0920-0920) to facilitate 
OMB approval of information collection needed to assess the 
effectiveness of social marketing messages aimed at increasing HIV/AIDS 
awareness, increasing prevention behaviors, and improving HIV testing 
rates among consumers. Specifically, in 2022 CDC received OMB approval 
to collect information for evaluating the acceptability and potential 
effectiveness of proposed concepts, messages, and taglines for a 
component of the Let's Stop HIV Together campaign (``Development of 
Messages for the Let's Stop HIV Together National Campaign''). This 
component emphasizes proven, effective prevention strategies, such as 
pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP). 
Information collection has been initiated but has not been completed.
    CDC is requesting OMB approval to extend the generic clearance and 
to complete information collection that supports campaign development 
and evaluation. Respondents will be recruited through national opt-in 
email lists, the internet, and external partnerships with community-
based and membership organizations that work with or represent 
individuals from targeted populations (e.g., National Urban League, the 
National Medical Association).
    To identify and reach target audiences, screening questions for up 
to 30,880 potential respondents may address one or more of the 
following items: Race/ethnicity, sexual behavior, sexual orientation, 
gender identity, HIV testing history, HIV status, and injection drug 
use. In addition, up to 5,445 respondents will be asked to complete a 
self-administered survey at home on a personal computer. Each targeted 
campaign survey will have a core set of items asked in all rounds, as 
well as a module of questions relating to specific Let's Stop HIV 
Together phases and activities.
    OMB approval is requested for three years and there is no cost to 
the respondents other than their time. The total estimated annualized 
burden is 3,751 hours.

[[Page 33148]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Individuals (male and female) aged 18   Study Screener..........          30,880               1            2/60
 years and older.
                                        Survey Module...........           5,445               1           30/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-10957 Filed 5-22-23; 8:45 am]
BILLING CODE 4163-18-P
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