Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11989 

FOR FURTHER INFORMATION CONTACT: For 

additional information about the 

information collection, contact Cathy 

Williams at (202) 418–2918 

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–0264. 

Title: Section 80.413, On-Board 

Station Equipment Records. 

Form Number: N/A. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Business or other forprofit entities, not-for-profit institutions, 

and state, local or tribal government. 

Number of Respondents: 1,000 

respondents; 1,000 responses. 

Estimated Time per Response: 2 

hours. 

Frequency of Response: 

Recordkeeping requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. Statutory 

authority for this information collection 

is contained in 47 U.S.C. 154, 303, 

307(e), 309 and 332 and 151–155 and 

sections 301–609 of the 

Communications Act of 1934, as 

amended. 

Total Annual Burden: 2,000 hours. 

Total Annual Cost: No cost. 

Privacy Impact Assessment: No 

impact(s). 

Nature and Extent of Confidentiality: 

There is no need for confidentiality. 

Needs and Uses: The Commission is 

seeking an extension of this expiring 

information collection in order to obtain 

the full three year approval from OMB. 

There is no change to the recordkeeping 

requirement. 

Section 80.413 requires the licensee of 

an on-board station to keep equipment 

records which show: 

(1) The ship name and identification 

of the on-board station; 

(2) The number of and type of 

repeater and mobile units used on-board 

the vessel; and 

(3) The date the type of equipment 

which is added or removed from the onboard station. 

The information is used by FCC 

personnel during inspections and 

investigations to determine what mobile 

units and repeaters are associated with 

on-board stations aboard a particular 

vessel. If this information were not 

maintained, no means would be 

available to determine if this type of 

radio equipment is authorized or who is 

responsible for its operation. 

Enforcement and frequency 

management programs would be 

negatively affected if the information 

were not retained. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary, Office of the Secretary, Office of 

the Managing Director. 

[FR Doc. 2015–05078 Filed 3–4–15; 8:45 am] 

BILLING CODE 6712–01P 

FEDERAL COMMUNICATIONS 

COMMISSION 

Federal Advisory Committee Act; 

Downloadable Security Technology 

Advisory Committee 

AGENCY: Federal Communications 

Commission. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice advises interested persons that 

the Federal Communications 

Commission’s (FCC or Commission) 

Downloadable Security Technology 

Advisory Committee (DSTAC) will hold 

a meeting on March 24, 2015. At the 

meeting, the Current Commercial 

Requirements Working Group and the 

Technology and Preferred Architectures 

Working Group will present their 

findings, the Advisory Committee will 

consider establishing more working 

groups, and the committee will discuss 

any other topics related to the DSTAC’s 

work that may arise. 

DATES: March 24, 2015. 

ADDRESSES: Federal Communications 

Commission, Room TW–C305 

(Commission Meeting Room), 445 12th 

Street SW., Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on this 

proceeding, contact Brendan Murray, 

Brendan.Murray@fcc.gov, of the Media 

Bureau, Policy Division, (202) 418–1573 

or Nancy Murphy, Nancy.Murphy@

fcc.gov, of the Media Bureau, (202) 418– 

1043. 

SUPPLEMENTARY INFORMATION: The 

meeting will be held on March 24, 2015, 

from 10:00 a.m. to 4:00 p.m. in the 

Commission Meeting Room of the 

Federal Communications Commission, 

Room TW–C305, 445 12th Street SW., 

Washington, DC 20554. 

The DSTAC is a Federal Advisory 

Committee that will ‘‘identify, report, 

and recommend performance objectives, 

technical capabilities, and technical 

standards of a not unduly burdensome, 

uniform, and technology- and platformneutral software-based downloadable 

security system.’’ 

The meeting on March 24, 2015, will 

be the second meeting of the DSTAC. 

The FCC will attempt to accommodate 

as many attendees as possible; however, 

admittance will be limited to seating 

availability. The Commission will 

provide audio and/or video coverage of 

the meeting over the Internet from the 

FCC’s Web page at http://www.fcc.gov/ 

live. The public may submit written 

comments before the meeting to 

Brendan Murray, DSTAC Designated 

Federal Officer, by email to DSTAC@

fcc.gov or by U.S. Postal Service Mail to 

445 12th Street SW., Room 4–A726, 

Washington, DC 20554. 

Open captioning will be provided for 

this event. Other reasonable 

accommodations for people with 

disabilities are available upon request. 

Requests for such accommodations 

should be submitted via email to 

fcc504@fcc.gov or by calling the 

Consumer & Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (tty). Such requests should 

include a detailed description of the 

accommodation needed. In addition, 

please include a way the FCC can 

contact you if it needs more 

information. Please allow at least five 

days’ advance notice; last-minute 

requests will be accepted, but may be 

impossible to fill. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 2015–05077 Filed 3–4–15; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0147] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products and 

Demonstrating the Substantial 

Equivalence of a New Tobacco 

Product: Responses to Frequently 

Asked Questions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES

11990 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collections in the 

guidances for industry and FDA staff 

entitled ‘‘Guidance for Industry and 

Food and Drug Administration Staff on 

Section 905(j) Reports: Demonstrating 

Substantial Equivalence for Tobacco 

Products’’ and ‘‘Demonstrating the 

Substantial Equivalence of a New 

Tobacco Product: Responses to 

Frequently Asked Questions.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 4, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry and Food and 

Drug Administration Staff on Section 

905(j) Reports: Demonstrating 

Substantial Equivalence for Tobacco 

Products—(OMB Control Number 0910– 

0673) (Extension) 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by adding a new chapter 

granting FDA authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 905(j) of the FD&C Act (21 

U.S.C. 387e(j)) authorizes FDA to 

establish the form for the submission of 

information related to substantial 

equivalence (SE). In guidance 

documents issued under the Good 

Guidances Practices regulation (21 CFR 

10.115), FDA provides 

recommendations intended to assist 

persons submitting reports under 

section 905(j) of the FD&C Act and 

explains, among other things, FDA’s 

interpretation of the statutory sections 

related to substantial equivalence. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Full SE 905(j)(1)(A)(i) and 910(a) ........................................................ 75 1 75 300 22,500 

Product Quantity Change SE Report .................................................. 125 1 125 87 10,875 

Same characteristics SE Report .......................................................... 100 1 100 47 4,700 

Totals ............................................................................................ .................... ........................ .................... .................... 38,075 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA has based these estimates on 

information it now has available from 

interactions with the industry, 

information related to other regulated 

products, and FDA’s expectations 

regarding the tobacco industry’s use of 

the section 905(j) pathway to market 

their products. Table 1 describes the 

annual reporting burden as a result of 

the implementation of the SE 

requirements of sections 905(j) and 

910(a) of the FDC Act (21 U.S.C. 

387j(a)). Based on current information, 

FDA now estimates that it will receive 

300 section 905(j) reports each year. Of 

these 300 reports, FDA estimates that 75 

of these reports will be ‘‘full’’ SE reports 

that take a manufacturer approximately 

300 hours to prepare. Under the newly 

issued guidance entitled, 

‘‘Demonstrating the Substantial 

Equivalence of a New Tobacco Product: 

Responses to Frequently Asked 

Questions,’’ FDA is recommending that 

certain modifications might be 

addressed in either a ‘‘Same 

Characteristics SE Report’’ or ‘‘Product 

Quantity Change Report.’’ FDA 

estimates that it will receive 100 Same 

Characteristics SE Reports and that it 

will take a manufacturer approximately 

47 hours to prepare this report. FDA 

estimates that it will receive 125 

Product Quantity Change SE Reports 

and that it will take a manufacturer 

approximately 87 hours to prepare this 

report. Therefore, FDA estimates the 

burden for submission of SE 

information will be 38,075 hours. 

Dated: February 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05024 Filed 3–4–15; 8:45 am] 

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