12596 Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices 

deemed appropriate) discussing the 

health effects of these ingredients. 

HHS has delegated responsibility for 

implementing the required information 

collection to CDC’s Office on Smoking 

and Health. Respondents are not 

required to submit specific forms; 

however, they are required to meet 

reporting guidelines and to submit the 

ingredient report by chemical name and 

Chemical Abstract Service (CAS) 

Registration Number, consistent with 

accepted reporting practices for other 

companies that are required to report 

ingredients added to other consumer 

products. Typically, respondents submit 

a summary report to CDC with the 

ingredient information for multiple 

products, or a statement that there are 

no changes to their previously 

submitted ingredient report. 

Respondents may submit the required 

information to CDC through a 

designated representative. The 

information collection is subject to strict 

confidentiality provisions. 

Ingredient reports for new SLT 

products are due at the time of first 

importation. Thereafter, ingredient 

reports are due annually on March 31. 

Information is submitted to OSH by 

mailing a written report on the 

respondent’s letterhead, by CD, threeinch floppy disk, or thumb drive. 

Electronic mail submissions are not 

accepted. Upon receipt and verification 

of the annual nicotine and ingredient 

report, OSH issues a Certificate of 

Compliance to the respondent. 

There are no changes to information 

collection procedures or the estimated 

burden per response. There is an 

increase in total estimated burden due 

to an increase in the estimated number 

of respondents, from 11 to 13. There are 

no costs to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Smokeless Tobacco Manufacturers, 

Packagers, and Importers.

SLT Nicotine and Ingredient and 

Report.

13 1 1,713 22,269 

Kimberly S. Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–4950 Filed 2–29–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Objective Work Plan (OWP), 

Objective Progress Report (OPR) and 

Project Abstract. 

OMB No.: 0980–0204. 

Description: Content changes are 

being proposed for the OPR and OWP 

ONLY. The information in the OPR is 

collected on a quarterly basis to monitor 

the performance of grantees and better 

gauge grantee progress. The 

standardized format allows ANA to 

report results across all its program 

areas and flag grantees that may need 

additional training and/or technical 

assistance to successfully implement 

their projects. The following are 

proposed changes within specific 

sections of the OPR form: 

Objective Work Plan Update Section: 

ANA has added fields for 1st through 

4th Quarter (Q1,Q2,Q3,Q4) to report the 

results for activities within each Project 

Objective. The grantee may continue to 

add to this form each quarter (rather 

than to a new form), reflecting 

cumulative results throughout the 

project period instead of a single 

quarter. 

Financial Section: ANA has added 2 

questions to: (1) Provide details on any 

income generated as a result of ANA 

project activities; (2) Provide details on 

any changes made to the budget during 

the reporting period. 

Native American Youth and Elder 

Opportunities Section: ANA has added 

a question to: (1) Request details on any 

intergenerational activities between 

grandparents and their grandchildren. 

Finally, ANA has added a new section 

(last section) to the form titled: 

PROJECT SUSTAINABILITY, to: (1) 

Request details on the grantee’s 

intention to continue the project 

benefits and/or services after ANA’s 

funding period for the project has 

ended. 

End of Changes to the OPR 

The OWP: The information collected 

through the OWP is needed to properly 

administer and monitor the 

Administration for Native Americans 

(ANA) programs. The OWP assists 

applicants in describing their projects’ 

objectives and activities, and also assists 

independent panel reviewers, ANA staff 

and the ANA Commissioner during 

review and funding decision process. 

Changes Specific Sections of the OWP 

Problem Statement: ANA added a 

field for applicants to include the 

problem statement they identified in 

their grant application. 

Position Performing the Activity: On 

the previous OWP, ANA requested 

applicants to identify the position 

responsible for each activity. ANA has 

changed this title to ‘‘position 

performing the activity’’ and applicants 

are asked to identify the lead person in 

one column and other support persons 

in the second column. 

End of Changes to the OWP 

Project Abstract: The Project Abstract 

form is no longer managed by ANA. 

Respondents: Tribal Government, 

Native Non-profit Organizations, Tribal 

Colleges & Universities. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

OWP ................................................................................................................ 500 1 3 1,500 

OPR ................................................................................................................. 275 4 1 1,100 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices 12597 

Estimated Total Annual Burden 

Hours: 2,850. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project. Fax: 202–395–7285. 

Email: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–4973 Filed 2–29–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0766] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey of ‘‘Health 

Care Providers’ Responses to Medical 

Device Labeling’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 2, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Survey of ‘Health Care Providers’ 

Responses to Medical Device 

Labeling’ ’’). Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Survey of ’’Health Care Providers’ 

Responses to Medical Device 

Labeling’’—21 CFR Part 801 (OMB 

Control Number 0910–NEW) 

The purpose of this study is to 

determine the most effective device 

labeling format and inform an FDA’s 

regulatory approach on standardized 

device labeling. Building upon the 

research methodology and success of 

the approach FDA used to evaluate drug 

labeling, we propose to ask health care 

providers (HCPs) to evaluate the quality 

of labeling (e.g. instructions for use, 

directions) for a medical device and to 

report the degree to which they could 

follow those instructions, how useful 

the information is, and how well 

organized the information is. This work 

will allow FDA to assess whether HCPs 

find the format and content of device 

labeling clear, understandable, useful, 

and user-friendly. Findings will provide 

evidence to inform FDA’s regulatory 

approach to standardizing medical 

device labeling across the United States. 

In the Federal Register of November 

1, 2011 (76 FR 67459), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. 

Two comments were received, 

however only one was related to the 

Paperwork Reduction Act of 1995. In 

response to the comments submitted by 

Advamed, FDA responses are as 

follows: 

(Comment 1) Comment 1 questioned 

whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility. 

(Response) The survey is designed to 

elicit responses on the formatting, 

content, and design of the template and 

not on the specific medical device 

chosen. This is stated at the beginning 

of the survey. FDA relies upon 

knowledgeable researchers to develop 

appropriate survey tools, and the 

research methodology to test content, 

format, and design of labeling is based 

on their expertise. Drugs instructions 

are written for all users, including 

health care providers and patients. The 

device labeling is written for all users, 

including health care providers and 

patients. We agree that industry could 

provide recommended contents and 

formats of labeling and encourage 

industry to do so. This survey is 

designed for the health care provider 

and their feedback. 

(Comment 2) Comment 2 questioned 

the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used. 

(Response) The survey is designed to 

elicit responses on the formatting, 

content, and design of the template and 

not on the specific medical device 

chosen. The terms used in the templates 

such as ‘‘warnings’’, 

‘‘contraindications’’, and ‘‘brand name’’ 

are commonly used terms in labeling for 

all devices. We are addressing what 

should be in a shortened version of 

labeling that will allow the user to 

operate it safely. The survey was 

designed by researchers with extensive 

knowledge in the area of testing 

labeling. It is anticipated that different 

health care practitioners will provide 

different answers based on their 

experiences; this is why we chose to ask 

various types of health care 

practitioners. The objective of the 

survey is to improve device labeling; it 

would not be possible to do a survey 

with a fictitious device that has no 

intended use as per the suggestion. All 

devices need to have intended use. 

(Comment 3) Comment 3 questioned 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected. 

(Response) We did not choose 

biomedical engineers as part of this 

survey because we wanted the people 

who interact with the pump in the 

presence of patients. The suggestion to 

add a question about whether a health 

care professional ever uses or reads 

device labeling and how to improve 

access to current device labeling was 

done in a previous study with focus 

groups. We developed the template 

survey based on the responses we 

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