[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Notices]
[Pages 65246-65247]
[FR Doc No: 2015-27065]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0027]

The 1,3-Butadiene Standard; Extension of the Office of Management
and Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the 1,3-Butadiene (BD)
Standard (29 CFR 1910.1051).

DATES: Comments must be submitted (postmarked, sent, or received) by
December 28, 2015.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit your comments and attachments
to the OSHA Docket Office, Docket No. OSHA-2012-0027, Occupational
Safety and Health Administration, U.S. Department of Labor, Room N-
2625, 200 Constitution Avenue NW., Washington, DC 20210. Deliveries
(hand, express mail, messenger, and courier service) are accepted
during the Department of Labor's and Docket Office's normal business
hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2012-0027) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You also may contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act
(PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information
is in the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupationl injuries, illnesses, and accidents
(29 U.S.C. 657). The OSH Act also requires that OSHA obtain such
information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    The BD Standard requires employers to monitor employee exposure to
1,3-Butadiene; develop and maintain compliance and exposure goal
programs if employee exposures to BD are above the Standard's
permissible exposure limits or action level; label respirator filter
elements to indicate the date and time it is first installed on the
respirator; establish medical surveillance programs to monitor employee
health, and to provide employees with information about their exposures
and the health effects of exposure to BD.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that the Office of Management and Budget (OMB)
extend the approval of the collection of information (paperwork)
requirements contained in the 1,3 Butadiene Standard (29 CFR
1910.1051). The Agency is requesting a one hour adjustment (from 916
hours to 915 burden hours). The adjustment is a result of the
elimination of the federal access from the burden hour calculation from
this ICR.
    Type of Review: Extension of a currently approved collection.
    Title: The 1,3 Butadiene Standard (29 CFR 1910.1051).
    OMB Number: 1218-0170.
    Affected Public: Business or other for-profits; Not-for-profit
organizations; Federal Government; State, Local, or Tribal Government.
    Number of Respondents: 50.
    Frequency of Response: On occasion.
    Total Responses: 3650.
    Average Time per Response: Time per response ranges from 15 seconds
(.004 hour) to write the date and time on each new cartridge label to 2
hours to complete a referral medical examination.
    Estimated Total Burden Hours: 915.
    Estimated Cost (Operation and Maintenance): $112,808.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile; or (3) by hard copy. All
comments, attachments, and other

material must identify the Agency name and the OSHA docket number for
this ICR (Docket No. OSHA-2012-0027). You may supplement electronic
submissions by uploading document files electronically. If you wish to
mail additional materials in reference to an electronic or facsimile
submission, you must submit them to the OSHA Docket Office (see the
section of this notice titled ADDRESSES). The additional materials must
clearly identify your electronic comments by your name, date, and the
docket number so the Agency can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as your social security number and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the Web site, and for assistance in using the Internet
to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act
(44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77
FR 3912).

    Signed at Washington, DC, on October 20, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-27065 Filed 10-23-15; 8:45 am]
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[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Notices]
[Page 4400-4401]
[DOCID:fr27ja10-94]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0026]

Draft Guidance for Industry on Assessment of Abuse Potential of
Drugs; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Assessment of
Abuse Potential of Drugs.'' This draft guidance is intended to assist
sponsors who are developing drug and other medical products with the
potential for abuse that may need to be scheduled under the Controlled
Substances Act. Drugs with abuse potential generally include drugs that
affect the central nervous system, drugs that are chemically or
pharmacologically similar to other drugs with known abuse potential,
and drugs that produce psychoactive effects such as sedation, euphoria,
or mood change.

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 draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 29, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Corinne P. Moody, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5144, Silver Spring, MD 20993-0002, 301-
796-5402.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Assessment of Abuse Potential of Drugs.'' Under the Federal
Food, Drug, and Cosmetic Act, an abuse potential assessment is part of
the general evaluation of the safety and efficacy of a drug to be used
under medical supervision. If a drug has abuse potential, the Secretary
of Health and Human Services (HHS) is required under the Controlled
Substances Act of 1970 (CSA) to make a recommendation for scheduling to
the Drug Enforcement Administration (DEA). The regulatory
responsibilities for this process are described in Title 21 United
States Code (U.S.C.) 811, with delegation of authority to FDA from HHS.
The Controlled Substance Staff (CSS) of FDA performs the scientific
evaluation of the abuse potential of a drug for HHS, in consultation
with the National Institute on Drug Abuse (NIDA), as described in a
Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518).
    When a sponsor submits a marketing application for a drug with
abuse potential to FDA for review, the sponsor is required to propose a
CSA schedule and provide a basis for this proposal (21 CFR
314.50(d)(5)(vii)). The sponsor's proposal is considered by the agency
during its evaluation of the drug's abuse potential. At the time a
marketing application is submitted to FDA for review, the sponsor signs
a statement agreeing not to market the product until the DEA makes a
final scheduling decision.
    FDA prepares a scientific analysis with a recommendation for
scheduling, based on the submission of the sponsor that includes a
scientific and medical evaluation of all relevant and available data,
an assessment of the public health risk, and a proposal for scheduling.
This recommendation is forwarded to DEA for consideration in the
decision on final scheduling of the drug. Scheduling results in
specific regulatory requirements relating to the drug's labeling,
prescribing, advertising, manufacturing, promotion, marketing, and use
in the practice of medicine. Not following these requirements can
result in criminal penalties.
    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 assessing
abuse potential of drugs. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any

mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: January 21, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1516 Filed 1-26-10; 8:45 am]
BILLING CODE 4160-01-S