Agency Information Collection Activities: Submission for OMB Review; Comment Request, 80665-80666 [2016-27455]

Download as PDF Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices following topics: Biosafety and biosecurity regulations; radiation threat preparedness and response; medical countermeasures; and risk communications. CONTACT PERSON FOR MORE INFORMATION: Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop D–44, Atlanta, Georgia 30329–4027, Telephone: (404) 639–7450; Facsimile: (404)639–7977; Email: OPHPR.BSC.Questions@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention, and Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Service Office, Centers for Disease Control and Prevention. [FR Doc. 2016–27493 Filed 11–15–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis Meeting (ACET) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Times and Dates: 8:30 a.m.–5:00 p.m., EST, December 12, 2016; 8:30 a.m.– 12:00 p.m., EST, December 13, 2016. Place: Corporate Square, Building 8, 1st Floor Conference Room, Atlanta, Georgia 30329, telephone (404) 639– 8317. This meeting is also accessible by Webinar: asabaliauskas on DSK3SPTVN1PROD with NOTICES December 12, 2016 For Participants: URL: https://www.mymeetings.com/nc/ join/ Conference number: PW1642870 Audience passcode: 4727233 Participants can join the event directly at: https://www.mymeetings.com/nc/ join.php?i=PW1642870& p=4727233&t=c USA Toll-free +1 (877) 951–7311, Participant code: 4727233 VerDate Sep<11>2014 16:23 Nov 15, 2016 Jkt 241001 Prevention and the Agency for Toxic Substances and Disease Registry. December 13, 2016 For Participants: URL: https://www.mymeetings.com/nc/ join/ Conference number: PW1642897 Audience passcode: 4727233 Participants can join the event directly at: https://www.mymeetings.com/nc/ join.php?i=PW1642897& p=4727233&t=c USA Toll-free +1 (877) 951–7311, Participant code: 4727233 Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. Persons who desire to make an oral statement, may request it at the time of the public comment period on December 13, 2016 at 11:40 a.m., (EDT). Public participation and ability to comment will be limited to space and time as it permits. Purpose: This Council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis. Matters for Discussion: Agenda items include the following topics: (1) Recently Published Data on TB in Jails and Prisons in the United States; (2) Expanded Latent TB Infection (LTBI) Testing and Treatment Plans (Massachusetts Demonstration Project); (3) Update on the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Economic Modeling Agreement (NEEMA) TB Projects; (4) Updates from Workgroups; and (5) other tuberculosis-related issues. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Margie Scott-Cseh, Centers for Disease Control and Prevention, 1600 Clifton Road NE., M/S E–07, Atlanta, Georgia 30333, telephone (404) 639–8317. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and PO 00000 Frm 00035 Fmt 4703 80665 Sfmt 4703 Elaine L. Baker, Director, Management Analysis and Services Office,Centers for Disease Control and Prevention. [FR Doc. 2016–27492 Filed 11–15–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers CMS–10287] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by December 16, 2016. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs Attention: CMS Desk Officer SUMMARY: E:\FR\FM\16NON1.SGM 16NON1 80666 Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices Fax Number: (202) 395–5806 OR Email: OIRA_submission@ omb.eop.gov To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Quality of Care Complaint Form; Use: In accordance with Section 1154(a)(14) of the Social Security Act, Quality Improvement Organizations (QIOs) are required to conduct appropriate reviews of all written complaints submitted by beneficiaries concerning the quality of care received. The Medicare Quality of Care Complaint Form will be used by Medicare beneficiaries to submit quality of care complaints. This form will establish a standard form for all beneficiaries to utilize and ensure pertinent information is obtained by QIOs to effectively process these complaints. Form Number: CMS–10287 (OMB control number: 0938–1102); Frequency: Occasionally; Affected asabaliauskas on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:23 Nov 15, 2016 Jkt 241001 Public: Individuals and Households; Number of Respondents: 3,500; Total Annual Responses: 3,500; Total Annual Hours: 583. (For policy questions regarding this collection contact Winsome Higgins at 410–786–1835.) Dated: November 9, 2016 William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016–27455 Filed 11–15–16; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–3744] Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER’s OPQ. DATES: Submit either an electronic or written proposal to participate in this program by January 17, 2017. See section IV of this document for information on what to include in such proposals. FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993–0002, 240–402–3969, email: CDEROPQSiteVisits@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background A critical part of the commitment by CDER to make safe and effective highquality drugs available to the American public is gaining an understanding of all aspects of drug development and a drug’s commercial life cycle, including the variety of drug manufacturing operations. To support this commitment, CDER has initiated various training and development programs, including the 2017 OPQ Staff Experiential Learning Site Visit PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Program. This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact a drug’s development program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities is an integral part of the program. II. The Site Visit Program In this site visit program, groups of OPQ staff—who have experience in a variety of backgrounds, including science, statistics, manufacturing, engineering and testing—will observe operations of commercial manufacturing, pilot plants, and testing over a 1- to 2-day period. To facilitate the learning process for OPQ staff, overview presentations by industry related to drug development and manufacturing may be provided, which may allow the participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes. OPQ encourages companies engaging in the development and manufacturing of both drug substances and drug products to respond. However, please note that this site visit program is not intended to supplement or to replace a regulatory inspection, e.g., a preapproval inspection, pre-license inspection or a surveillance inspection. OPQ staff participating in this program will grow professionally by gaining a better understanding of current industry practices, processes, and procedures. Although observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ has identified a number of areas of particular interest to its staff. The following list identifies some of these areas but is not intended to be exhaustive or to limit industry response: • Drug products and active pharmaceutical ingredients Æ Solutions, suspensions, emulsions, and semisolids Æ Sustained, modified, and immediate release formulations Æ Drug-device combination products, particularly inhalation, transdermal, iontophoretic, and implant formulations Æ Biotechnology products • Design, development, manufacturing, and controls Æ Engineering controls for aseptic formulations Æ Unique delivery technologies E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80665-80666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10287]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by December 16, 2016.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions:
    OMB, Office of Information and Regulatory Affairs
    Attention: CMS Desk Officer

[[Page 80666]]

    Fax Number: (202) 395-5806 OR
    Email: OIRA_submission@omb.eop.gov
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Quality 
of Care Complaint Form; Use: In accordance with Section 1154(a)(14) of 
the Social Security Act, Quality Improvement Organizations (QIOs) are 
required to conduct appropriate reviews of all written complaints 
submitted by beneficiaries concerning the quality of care received. The 
Medicare Quality of Care Complaint Form will be used by Medicare 
beneficiaries to submit quality of care complaints. This form will 
establish a standard form for all beneficiaries to utilize and ensure 
pertinent information is obtained by QIOs to effectively process these 
complaints. Form Number: CMS-10287 (OMB control number: 0938-1102); 
Frequency: Occasionally; Affected Public: Individuals and Households; 
Number of Respondents: 3,500; Total Annual Responses: 3,500; Total 
Annual Hours: 583. (For policy questions regarding this collection 
contact Winsome Higgins at 410-786-1835.)

    Dated: November 9, 2016
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-27455 Filed 11-15-16; 8:45 am]
 BILLING CODE 4120-01-P
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