Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Notices 20345 

II. Electronic Access 

Persons with access to the Internet 

may obtain the summaries at http:// 

www.fda.gov/cder/pediatric/index.htm. 

Dated: April 16, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–7717 Filed 4–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0122] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Computerized Labor Monitoring 

Systems; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for Industry and FDA Staff; 

Class II Special Controls Guidance 

Document: Computerized Labor 

Monitoring Systems.’’ This guidance 

document describes a means by which 

computerized labor monitoring systems 

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 computerized labor 

monitoring systems into class II (special 

controls). This guidance document is 

being immediately implemented as the 

special control for computerized labor 

monitoring systems, but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs). 

DATES: Submit written or electronic 

comments on this 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 ‘‘Guidance for Industry and 

FDA Staff; Class II Special Controls 

Guidance Document: Computerized 

Labor Monitoring Systems’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments tohttp:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Glenn Bell, Center for Devices and 

Radiological Health (HFZ–470), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying computerized labor 

monitoring systems into class II (special 

controls) under section 513(f)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for computerized labor 

monitoring systems. Section 513(f)(2) of 

the act provides that any person who 

submits a premarket notification under 

section 510(k) of the 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 act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the 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 time frames established by section 

513(f)(2) of the 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. Thus, FDA is issuing this 

guidance document as a level 1 

guidance document that is immediately 

implemented. 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 GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on 

computerized labor monitoring systems. 

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. To receive ‘‘Guidance for 

Industry and FDA Staff; Class II Special 

Controls Guidance Document: 

Computerized Labor Monitoring 

Systems,’’ you may either send an email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 240–

276–3151 to receive a hard copy. Please 

use the document number 1625 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information, 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

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 (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; and the collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 


jlentini on PROD1PC65 with NOTICES
20346 Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Notices 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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: April 13, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–7700 Filed 4–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) The 

necessity of the proposed collection of 

information for the proper performance 

of the functions of the agency; (b) the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: The National Health 

Service Corps Loan Repayment 

Program (OMB No. 0915–0127)— 

Extension 

The National Health Service Corps 

(NHSC) Loan Repayment Program (LRP) 

was established to assure an adequate 

supply of trained primary care health 

care professionals to provide services in 

the neediest Health Professional 

Shortage Areas (HPSAs) of the United 

States. Under this program, the 

Department of Health and Human 

Services agrees to repay the educational 

loans of the primary care health 

professionals. In return, the health 

professionals agree to serve for a 

specified period of time in a federallydesignated HPSA approved by the 

Secretary for LRP participants. 

The NHSC LRP forms provide 

information that is needed for selecting 

participants and repaying qualifying 

loans for education. The LRP forms 

include the following: The NHSC LRP 

Application, the Loan Information and 

Verification form, the Community Site 

Information form, the Request for 

Method of Advanced Loan Repayment 

form, the Applicant Checklist, the 

Payment Information form, and the 

Authorization to Release Information 

form. 

The estimated annual burden is as 

follows: 

Type of form Number of 

respondents 

Responses 

per 

respondent 

Total number 

of responses 

Hours per 

response 

Total burden 

hours 

NHSC LRP Application ...................................................... 1920 1 1920 .5 960 

Community Site Information form ...................................... 1920 1 1920 .25 480 

Loan Information and Verification form ............................. 1920 3 5760 .25 1440 

Authorization to Release Information ................................ 1920 1 1920 .1 192 

Applicant Checklist ............................................................. 1920 1 1920 .2 384 

Lenders .............................................................................. 80 1 80 .25 20 

Total ............................................................................ 2000 13520 3476 

Send comments to Susan G. Queen, 

PhD, HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: April 16, 2007. 

Caroline Lewis, 

Acting Associate Administrator for 

Administration and Financial Management. 

[FR Doc. E7–7762 Filed 4–23–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on 

Interdisciplinary, Community-Based 

Linkages; Notice of Request for 

Nominations 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill 11 

vacancies on the Advisory Committee 

on Interdisciplinary, Community-Based 

Linkages (ACICBL). 

AUTHORITY: 42 U.S.C. 294f, Section 756 

of the Public Health Service Act, as 

amended. The Advisory Committee is 

governed by provisions of Public Law 

(Pub. L.) 92–463, as amended (5 U.S.C. 

Appendix 2) which sets forth standards 

for the formation and use of advisory 

committees. 

DATES: The Agency must receive 

nominations on or before June 30, 2007. 

ADDRESSES: All nominations are to be 

submitted to Louis D. Coccodrilli, 

Designated Federal Official, ACICBL, 

Bureau of Health Professions (BHPr), 

HRSA, Parklawn Building, Room 9–05, 

5600 Fishers Lane, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Saldanha, Public Health 

Fellow, AHEC Branch, Division of State, 

Community, and Public Health, BHPr, 


jlentini on PROD1PC65 with NOTICES