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 

mstockstill on DSK4VPTVN1PROD with NOTICES

12598 Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices 

received in those focus group sessions. 

We agree that responses will vary 

depending on the professional group 

and anticipate this. We developed this 

survey with professional researchers 

who develop surveys, and this was also 

tested internally. We trust that the 

questions and how they are asked are 

what we need in order to inform any 

further actions on medical device 

labeling content and format 

development. In regard to conducting 

objective usability tests with a range of 

medical device types, we encourage 

others to perform these types of tests 

and share the results with FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Interviews 

Physicians ............................................................................ 6 1 6 1 6 

Advanced practice nurses (NPs) and registered nurses ..... 9 1 9 1 9 

Medical technicians .............................................................. 9 1 9 1 9 

Subtotal ......................................................................... 24 1 24 1 24 

Survey 

Physicians ............................................................................ 120 1 120 0.5 60 

Advanced practice nurses (NPs) and registered nurses ..... 240 1 240 0.5 120 

Medical technicians .............................................................. 240 1 240 0.5 120 

Total .............................................................................. 624 1 624 0.5 324 

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

Dated: February 27, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–4969 Filed 2–29–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice Correction; A Multi-Center 

International Hospital-Based CaseControl Study of Lymphoma in Asia 

(AsiaLymph) (NCI) 

The Federal Register notice published 

on February 24, 2012 (77 FR 11136) 

announcing the submission to OMB of 

the project titled, ‘‘A multi-center 

international hospital-based casecontrol study of lymphoma in Asia 

(AsiaLymph) (NCI)’’ was submitted with 

an error. The ‘‘Type of Information 

Collection Request’’ was incorrectly 

listed as an Emergency. This submission 

should be considered a new submission. 

Dated: February 24, 2012. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–4884 Filed 2–29–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: AIDS and Related 

Research Integrated Review Group, 

NeuroAIDS and other End-Organ Diseases 

Study Section. 

Date: March 20, 2012. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Delfina Santa Monica 

Hotel, 530 West Pico Boulevard, Santa 

Monica, CA 90405. 

Contact Person: Eduardo A. Montalvo, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1168, montalve@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Cognition, Perception and Speech. 

Date: March 20, 2012. 

Time: 3 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Weijia Ni, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 3184, MSC 7848, Bethesda, MD 

20892, (301) 237–9918, niw@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Review of 

Behavioral and Social HIV/AIDS RFA 

Applications. 

Date: March 21, 2012. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Delfina Santa Monica 

Hotel, 530 West Pico Boulevard, Santa 

Monica, CA 90405. 

Contact Person: Mark P. Rubert, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Learning and Memory. 

Date: March 21, 2012. 

Time: 1 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: M. Catherine Bennett, 

Ph.D., Scientific Review Officer, Center for 

mstockstill on DSK4VPTVN1PROD with NOTICES