Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 71437 

IV. Paperwork Reduction Act of 1995 

This guidance refers to currently 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) (the PRA). The collections of 

information in 21 CFR part 801 are 

approved under OMB control number 

0910–0485 and the collections of 

information in 21 CFR part 610, subpart 

G, are approved under OMB control 

number 0910–0338. 

The labeling provisions recommended 

in this guidance are not subject to 

review by OMB because they do not 

constitute a ‘‘collection of information’’ 

under the PRA. Rather, the 

recommended labeling is a ‘‘public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)). 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://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 http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28265 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1936] 

Establishment of a Public Docket; 

Electronic Cigarettes and the Public 

Health Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of docket; 

request for data, information, and 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Tobacco Products, is establishing a 

public docket in conjunction with the 

first public workshop to gather scientific 

information about electronic cigarettes 

(e-cigarettes) as announced in Docket 

No. FDA–2014–N–0001–0079. 

Regardless of attendance at the public 

workshop, interested parties are invited 

to submit comments, supported by 

research and data, regarding electronic 

cigarettes and the public health. 

DATES: Submit written or electronic 

comments by April 15, 2015. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Cohen, Office of Science, Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 1–877–287–1373, email: 

workshop.CTPOS@fda.hhs.gov. 

I. Background 

On September 17, 2014, FDA 

announced a public workshop to gather 

information about e-cigarettes and the 

public health (Electronic Cigarettes and 

the Public Health; Public Workshop; 79 

FR 55815, September 17, 2014, Docket 

No. FDA–2014–N–0001). The focus of 

the workshop is product science 

(specifically device designs and 

characteristics, and e-liquid and aerosol 

constituents), product packaging, 

constituent labeling, and environmental 

impact. FDA intends to follow the first 

workshop with two additional ecigarette workshops; one on individual 

health effects and one on population 

health effects. As stated in the Federal 

Register notice of the public workshop, 

the workshops are not intended to 

inform the Agency’s deeming 

rulemaking. The workshops are 

intended to better inform FDA about 

these products. Should the Agency 

move forward as proposed to regulate ecigarettes, additional information about 

the products would assist the Agency in 

carrying out its responsibilities under 

the law. 

II. Submission of Comments 

Regardless of attendance at the public 

workshop, interested parties are invited 

to submit comments, supported by 

research and data, regarding e-cigarettes 

and the public health. Information 

related to workshop presentations and 

discussion topics, including specific 

questions to be addressed at the 

workshop, can be found at http://

www.fda.gov/TobaccoProducts/

NewsEvents/ucm238308.htm. 

Interested persons may submit either 

electronic comments to this docket at 

http://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 http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28261 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than January 2, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 


rljohnson on DSK3VPTVN1PROD with NOTICES