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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70272 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

513(a)(1) of the FD&C Act. FDA shall, 

within 60 days of receiving such a 

request, classify the device by written 

order. This classification shall be the 

initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the FD&C Act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the Agency’s 

current thinking on non-powered 

suction apparatus devices intended for 

negative pressure wound therapy. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Non-powered 

Suction Apparatus Device Intended for 

Negative Pressure Wound Therapy 

(NPWT),’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1701 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

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 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 50 have been approved under OMB 

control number 0910–0586; the 

collections of information in 21 CFR 56 

have been approved under OMB control 

number 0910–0130; and the collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: November 10, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28872 Filed 11–16–10; 8:45 am] 

BILLING CODE 4160–01–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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Clinical Decision Making and 

Treatment. 

Date: November 23, 2010. 

Time: 10 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Anna L. Riley, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7759, Bethesda, MD 20892, 301–435– 

2889, rileyann@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Personality and Health. 

Date: November 29, 2010. 

Time: 11 a.m. to 12 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: Anna L. Riley, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7759, Bethesda, MD 20892, 301–435– 

2889, rileyann@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Memory, Stress, Pain, and Alcohol. 

Date: December 1–2, 2010. 

Time: 7 a.m. to 8 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Michael Selmanoff, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3134, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, mselmanoff@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Molecular and Cellular HIV Biology. 

Date: December 1, 2010. 

Time: 11 a.m. to 1 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: Robert Freund, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3200, 

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