Submission for OMB Review; 30-Day Comment Request: Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI), 55264-55265 [2013-21977]

Download as PDF 55264 Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices SUPPLEMENTARY INFORMATION: sroberts on DSK5SPTVN1PROD with NOTICES I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for fluticasone propionate; salmeterol xinafoate. Advair Diskus (fluticasone propionate; salmeterol xinafoate), new drug application 021077, was initially approved by FDA in August 2000. There are no approved ANDAs for this product. FDA is now issuing a draft guidance for industry on BE recommendations for generic fluticasone propionate; salmeterol xinafoate (Draft Fluticasone Propionate; Salmeterol Xinafoate BE Recommendations). In December 2009, GlaxoSmithKline (GSK), manufacturer of the reference listed drug Advair Diskus, submitted a citizen petition requesting that FDA withhold approval of any ANDA or 505(b)(2) application for generic oral inhalation products containing fluticasone propionate and/or salmeterol xinafoate unless certain conditions were satisfied, including conditions related to demonstrating BE (Docket No. FDA–2009–P–0597). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Draft Fluticasone Propionate; Salmeterol Xinafoate BE Recommendations before responding to GSK’s citizen petition. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for fluticasone propionate; salmeterol xinafoate. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. VerDate Mar<15>2010 16:10 Sep 09, 2013 Jkt 229001 II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: September 3, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21892 Filed 9–9–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on the National Health Service Corps (NHSC). Dates and Times: September 26, 2013, 2:00 p.m.–3:30 p.m. (EST). Place: The meeting will be via audio conference call. Status: The meeting will be open to the public. Agenda: The Council is holding a meeting via conference call to discuss the National Health Service Corps role in the Affordable Care Act. The public can join the meeting via audio conference call on the date and time specified above using the following information: Dial-in number: 1–800– 857–5081; Passcode: 1060359. There will be an opportunity for the public to comment towards the end of the call. FOR FURTHER INFORMATION CONTACT: Njeri Jones, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, DATES: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Parklawn Building, Room 13–64, 5600 Fishers Lane, Rockville, Maryland 20857; email: NJones@hrsa.gov; telephone: 301–443–2541. Dated: September 4, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–21966 Filed 9–9–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 19, 2013, Vol. 78, page 36788 and allowed 60-days for public comment. One public comment was received on June 21, 2013 requesting the data collection plans and instruments. This information was sent to the individual on June 24, 2013. Another comment was received on August 14, 2013. Data collection plans and instruments were sent to the requester on August 14, 2013. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: E:\FR\FM\10SEN1.SGM 10SEN1 55265 Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Sarah Kobrin, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., MSC 9761, Rockville, MD 20852, or call nontoll-free number 240–276–6931 or Email your request, including your address to: kobrins@mail.nih.gov. Formal requests FOR FURTHER INFORMATION CONTACT: perhaps affecting the disease stage of diagnosis and the effectiveness of treatment. Data will be collected from approximately 2,000 adults aged 50 years or older across the United States will be recruited for the NCI Awareness and Beliefs about Cancer survey over a one-year period. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,334. for additional plans and instruments must be requested in writing. Proposed Collection: Awareness and Beliefs about Cancer Survey, 0925– NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The objective of the study is gather data about American adults’ awareness and beliefs about cancer. The ultimate goal is to determine how individuals’ perceptions of cancer may influence their decisions to report signs and symptoms to health care providers, ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Type of respondent Screener ............................................ Survey ............................................... General Public .................................. Adults 50+ years old ........................ [FR Doc. 2013–21977 Filed 9–9–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 4, 2013. Michelle Trout, Program Analyst, Office of the Federal Advisory Committee Policy. National Institutes of Health National Library of Medicine; Notice of Closed Meeting sroberts on DSK5SPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 USC, as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Library of Medicine Special Emphasis Panel; Conflicts R01/K22. Date: October 30, 2013. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Zoe E. Huang, M.D., Scientific Review Officer, Extramural VerDate Mar<15>2010 16:10 Sep 09, 2013 Jkt 229001 8,000 2,000 Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–594–4937, huangz@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: September 4, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2013–21948 Filed 9–9–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDA. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) 1 1 Total annual burden hour 5/60 20/60 667 667 Name of Committee: Board of Scientific Counselors, NIDA. Date: October 22, 2013. Closed: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus, Baltimore, MD 21223. Contact Person: Joshua Kysiak, Program Specialist, Biomedical Research Center, Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore, MD 21224, 443–740–2465, kysiakjo@nida.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: September 4, 2013. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–21947 Filed 9–9–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and E:\FR\FM\10SEN1.SGM 10SEN1

Agencies

[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55264-55265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21977]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: Awareness and 
Beliefs About Cancer Survey, National Cancer Institute (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH), has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on June 19, 2013, Vol. 78, page 36788 and allowed 60-days for 
public comment. One public comment was received on June 21, 2013 
requesting the data collection plans and instruments. This information 
was sent to the individual on June 24, 2013. Another comment was 
received on August 14, 2013. Data collection plans and instruments were 
sent to the requester on August 14, 2013. The purpose of this notice is 
to allow an additional 30 days for public comment. The National Cancer 
Institute (NCI), National Institutes of Health may not conduct or 
sponsor, and the respondent is not required to respond to, an 
information collection that has been extended, revised, or implemented 
on or after October 1, 1995, unless it displays a currently valid OMB 
control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

[[Page 55265]]


FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Sarah 
Kobrin, Division of Cancer Control and Population Sciences, 9609 
Medical Center Dr., MSC 9761, Rockville, MD 20852, or call non-toll-
free number 240-276-6931 or Email your request, including your address 
to: kobrins@mail.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: Awareness and Beliefs about Cancer Survey, 
0925-NEW, National Cancer Institute (NCI), National Institutes of 
Health (NIH).
    Need and Use of Information Collection: The objective of the study 
is gather data about American adults' awareness and beliefs about 
cancer. The ultimate goal is to determine how individuals' perceptions 
of cancer may influence their decisions to report signs and symptoms to 
health care providers, perhaps affecting the disease stage of diagnosis 
and the effectiveness of treatment. Data will be collected from 
approximately 2,000 adults aged 50 years or older across the United 
States will be recruited for the NCI Awareness and Beliefs about Cancer 
survey over a one-year period.
    OMB approval is requested for one year. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,334.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Screener......................  General Public..           8,000               1            5/60             667
Survey........................  Adults 50+ years           2,000               1           20/60             667
                                 old.
----------------------------------------------------------------------------------------------------------------


    Dated: September 4, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-21977 Filed 9-9-13; 8:45 am]
BILLING CODE 4140-01-P
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