Draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention, 37228-37229 [2017-16801]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 37228 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices OMB control number: 7100–NEW. Frequency: Quantitative Survey, annually; Qualitative Survey, occasionally. Respondents: Consumers. Estimated number of respondents: Quantitative Survey, 17,000 respondents; Qualitative Survey, 30 respondents. Estimated average hours per response: Quantitative Survey, 0.47 hours; Qualitative Survey, 2 hours. Estimated annual burden hours: Quantitative Survey, 7,990 hours; Qualitative Survey, 180 hours. General description of report: The information collected could be used for the Board’s Report on the Economic Well-Being of U.S. Households, for Board studies or working papers, professional journals, the Federal Reserve Bulletin, testimony and reports to the Congress, or other vehicles. Such event-driven consumer data collections could also be used to inform Board policy, regulatory, supervisory and operational decisions. 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[FR Doc. 2017–16773 Filed 8–8–17; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2017–0068, NIOSH–299] Draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for comments. AGENCY: As steward of the National Occupational Research Agenda (NORA), the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention Agenda for public comment. Written by the NORA Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention Cross-Sector Council, the Agenda identifies the most important occupational safety and health research needs for the next decade, 2016–2026. A copy of the draft Agenda is available at https:// www.regulations.gov (search Docket Number CDC–2017–0068). SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Electronic or written comments must be received by October 10, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC–2017– 0068 and docket number NIOSH–299, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C–34, Cincinnati, Ohio 45226–1998. Instructions: All submissions received must include the agency name and Docket Number [CDC–2017–0068; NIOSH–299]. All relevant comments received will be posted without change to https://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Emily Novicki (NORACoordinator@ cdc.gov), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E–20, 1600 Clifton Road NE., Atlanta, GA 30329. SUPPLEMENTARY INFORMATION: The National Occupational Research Agenda (NORA) is a partnership program created to stimulate innovative research and improved workplace practices. The national agenda is developed and implemented through the NORA sector and cross-sector councils. Each council develops and maintains an agenda for its sector or cross-sector. The National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and other Chronic Disease Prevention (CRC) is intended to identify the research, information, and actions most urgently needed to prevent occupational cancer, adverse reproductive outcomes and cardiovascular disease. The National Occupational Research Agenda for CRC provides a vehicle for industry stakeholders to describe the most relevant issues, gaps, and safety and health needs for the sector. It is meant to be broader than any one agency or organization. It is a strategic plan for the entire country and all of its research and development entities, whether government, higher education, or industry. This is the first CRC Agenda, developed for the third decade of NORA (2016–2026). The agenda was developed considering new information about injuries and illnesses, the state of the science, and the probability that new information and approaches will make a difference. DATES: E:\FR\FM\09AUN1.SGM 09AUN1 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices As the steward of the NORA process, NIOSH invites comments on the draft National Occupational Research Agenda for CRC. A copy of the draft Agenda is available at https://www.regulations.gov (see Docket Number CDC–2017–0068, NIOSH–299). John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2017–16801 Filed 8–8–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–0829] Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.’’ The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety. Since FDA’s guidance documents do not bind the public or FDA to any requirements, they have not been considered to be subject to Executive Order 12866. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance, submit sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:00 Aug 08, 2017 Jkt 241001 either electronic or written comments on the draft guidance by October 10, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–D–0829 for ‘‘Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 37229 made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft guidance document. FOR FURTHER INFORMATION CONTACT: Bill Harvey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993–0002, 240–402–4180. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised draft guidance for industry E:\FR\FM\09AUN1.SGM 09AUN1

Agencies

[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37228-37229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2017-0068, NIOSH-299]


Draft National Occupational Research Agenda for Cancer, 
Reproductive, Cardiovascular and Other Chronic Disease Prevention

AGENCY: National Institute for Occupational Safety and Health (NIOSH), 
Centers for Disease Control and Prevention (CDC), Department of Health 
and Human Services (HHS).

ACTION: Request for comments.

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

SUMMARY: As steward of the National Occupational Research Agenda 
(NORA), the National Institute for Occupational Safety and Health of 
the Centers for Disease Control and Prevention announces the 
availability of the draft National Occupational Research Agenda for 
Cancer, Reproductive, Cardiovascular and Other Chronic Disease 
Prevention Agenda for public comment. Written by the NORA Cancer, 
Reproductive, Cardiovascular and Other Chronic Disease Prevention 
Cross-Sector Council, the Agenda identifies the most important 
occupational safety and health research needs for the next decade, 
2016-2026. A copy of the draft Agenda is available at https://www.regulations.gov (search Docket Number CDC-2017-0068).

DATES: Electronic or written comments must be received by October 10, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0068 and docket number NIOSH-299, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All submissions received must include the agency name 
and Docket Number [CDC-2017-0068; NIOSH-299]. All relevant comments 
received will be posted without change to https://regulations.gov, 
including any personal information provided. For access to the docket 
to read background documents or comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Emily Novicki 
(NORACoordinator@cdc.gov), National Institute for Occupational Safety 
and Health, Centers for Disease Control and Prevention, Mailstop E-20, 
1600 Clifton Road NE., Atlanta, GA 30329.

SUPPLEMENTARY INFORMATION: The National Occupational Research Agenda 
(NORA) is a partnership program created to stimulate innovative 
research and improved workplace practices. The national agenda is 
developed and implemented through the NORA sector and cross-sector 
councils. Each council develops and maintains an agenda for its sector 
or cross-sector. The National Occupational Research Agenda for Cancer, 
Reproductive, Cardiovascular and other Chronic Disease Prevention (CRC) 
is intended to identify the research, information, and actions most 
urgently needed to prevent occupational cancer, adverse reproductive 
outcomes and cardiovascular disease. The National Occupational Research 
Agenda for CRC provides a vehicle for industry stakeholders to describe 
the most relevant issues, gaps, and safety and health needs for the 
sector. It is meant to be broader than any one agency or organization. 
It is a strategic plan for the entire country and all of its research 
and development entities, whether government, higher education, or 
industry.
    This is the first CRC Agenda, developed for the third decade of 
NORA (2016-2026). The agenda was developed considering new information 
about injuries and illnesses, the state of the science, and the 
probability that new information and approaches will make a difference.

[[Page 37229]]

    As the steward of the NORA process, NIOSH invites comments on the 
draft National Occupational Research Agenda for CRC. A copy of the 
draft Agenda is available at https://www.regulations.gov (see Docket 
Number CDC-2017-0068, NIOSH-299).

John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-16801 Filed 8-8-17; 8:45 am]
 BILLING CODE 4163-18-P
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