Draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention, 37228-37229 [2017-16801]
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
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Margaret McCloskey Shanks,
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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:
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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:
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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]
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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:
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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
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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
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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]
=======================================================================
-----------------------------------------------------------------------
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