70270 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS—Continued 

Type of 

respondents Survey instrument Number of respondents 

Frequency of 

response 

Average time per 

response 

(min/hr) 

Annual burden 

hours 

Board Members ......... Pediatric CIRB Reviewer Findings—Initial 

Review of Cooperative Group Protocol 

(Attachment 6B).

12 1 4 hours ...................... 48 

Board Members ......... Adult CIRB Reviewer Findings Cooperative 

Group Response to CIRB Review (Attachment 6C).

25 1 1 hour ........................ 25 

Board Members ......... Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review 

(Attachment 6D).

70 1 1 hour ........................ 70 

Board Members ......... Adult CIRB Reviewer Findings Amendment 

Cooperative Group Protocol (Attachment 

6E).

130 1 1.5 hours ................... 195 

Board Members ......... Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attachment 6F).50 1 1.5 hours ................... 75 

Board Members ......... Adult CIRB Reviewer Findings Continuing 

Review of Cooperative Group Protocol 

(Attachment 6G).

150 1 .5 hour ....................... 75 

Board Members ......... Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6H).110 1 .5 hour ....................... 55 

Board Members ......... CIRB Reviewer Form (Attachment 6I) ......... 20 1 2 hours ...................... 40 

Board Members ......... CIRB Statistical Reviewer Form (Attachment 6J).20 1 2 hours ...................... 40 

Board Members ......... CIRB SAE Reviewer Worksheet (Attachment 6K).10 15 30/60 (.5 hour) .......... 75 

Total ................... ....................................................................... 4,904 ........................ ................................... 2,209 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Jeanne 

Adler, Division of Cancer Treatment and 

Diagnosis or call non-toll-free number 

301–594–0083 or e-mail your request, 

including your address to: 

adlerj@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: November 10, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–28883 Filed 11–16–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Pretesting of 

NIAID’s Biomedical HIV Prevention 

Research Communication Messages 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Allergy and 

Infectious Diseases (NIAID), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Pretesting 

of NIAID’s Biomedical HIV Prevention 

Research Communication Messages. 

Type of Information Collection Request: 

Revision of a previously approved 

collection. Need and Use of Information 

Collection: This is a request for 

clearance to pretest messages, materials 

and program activities about biomedical 

HIV prevention research. The primary 

objectives of the pretests are to (1) 

Assess audience knowledge, attitudes, 

behaviors and other characteristics for 

the planning/development of health 

messages, education products, 

communication strategies, and public 

information programs; and (2) pretest 

these health messages, products, 

strategies, and program components 

while they are in developmental form to 

assess audience comprehension, 

reactions, and perceptions. The 

information obtained from audience 

research and pretesting results in more 

effective messages, materials, and 

programmatic strategies. By maximizing 

the effectiveness of these messages and 

strategies for reaching targeted 

audiences, the frequency with which 

publications, products, and programs 

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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 70271 

need to be modified is reduced. 

Frequency of Response: On occasion. 

Affected Public: Individuals. Type of 

Respondents: Adults at risk for HIV/ 

AIDS; representatives of organizations 

disseminating HIV-related messages or 

materials. The annual reporting burden 

is shown in the table below. There are 

no Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Type of respondents Estimated number 

of respondents 

Estimated number 

of responses per 

respondent 

Average burden 

hours per response 

Estimated total 

annual burden hours 

requested 

General public ................................................................ 2,988 1 .40 1,195 .2 

Community-Based Organization Managers ................... 749 1–3 .31 232 .19 

Healthcare Providers ..................................................... 107 1 .32 34 .24 

Total ........................................................................ 3,844 ................................ ................................ 1,461 .63 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION: To request 

more information on the proposed 

project or to obtain a copy of the data 

collection plans and instruments, 

contact Katharine Kripke, Assistant 

Director, Vaccine Research Program, 

Division of AIDS, NIAID, NIH, 6700B 

Rockledge Dr., Bethesda, MD 20892– 

7628, or call non-toll-free number 301– 

402–0846, or E-mail your request, 

including your address to 

kripkek@niaid.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: November 10, 2010. 

John J. McGowan, 

Deputy Director for Science Management 

NIAID. 

[FR Doc. 2010–28980 Filed 11–16–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0515] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Non-Powered Suction Apparatus 

Device Intended for Negative Pressure 

Wound Therapy; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Non-powered Suction 

Apparatus Device Intended for Negative 

Pressure Wound Therapy (NPWT).’’ This 

guidance document describes a means 

by which non-powered suction 

apparatus devices intended for NPWT 

may comply with the requirement of 

special controls for class II devices. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

to classify non-powered suction 

apparatus devices intended for NPWT 

into class II (special controls). This 

guidance document is immediately in 

effect as the special control for nonpowered suction apparatus devices 

intended for NPWT, but it remains 

subject to comment in accordance with 

the Agency’s good guidance practices 

(GGPs). 

DATES: Submit either electronic or 

written comments on the guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Non-powered 

Suction Apparatus Device Intended for 

Negative Pressure Wound Therapy 

(NPWT)’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4617, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

guidance 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: 

Jiyoung M. Dang, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3615, Silver Spring, 

MD 20993, 301–796–5650. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying non-powered suction 

apparatus devices intended for negative 

pressure wound therapy into class II 

(special controls) under section 513(f)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(2)). This guidance document 

will serve as the special control for nonpowered suction apparatus devices 

intended for negative pressure wound 

therapy device. Section 513(f)(2) of the 

FD&C Act provides that any person who 

submits a premarket notification under 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the FD&C Act, 

request that FDA classify the device 

under the criteria set forth in section 

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