20344 Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Notices 

Dated: April 18, 2007. 

Maryam Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–7732 Filed 4–23–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

President’s Committee for People With 

Intellectual Disabilities; Notice of 

Meeting 

AGENCY: President’s Committee for 

People with Intellectual Disabilities 

(PCPID), Administration for Children 

and Families, HHS. 

ACTION: Notice of quarterly meeting. 

DATES: Monday, May 14, 2007, from 9 

a.m.–5 p.m. EST, and Tuesday, May 15, 

2007, from 9 a.m.–2 p.m. EST. The 

meeting will be open to the public. 

ADDRESSES: The meeting will be held in 

Room 800 of the Hubert H. Humphrey 

Building, 200 Independence Ave., SW., 

Washington, DC 20201. Individuals who 

will need accommodations for a 

disability in order to attend the meeting 

(e.g., interpreting services, assistive 

listening devices, materials in 

alternative format such as large print or 

Braille) should notify Kodie Ruzicka via 

e-mail at kruzicka@acf.hhs.gov, or via 

telephone at 202–205–7989 no later 

than May 1, 2007. PCPID will attempt to 

meet requests made after that date, but 

cannot guarantee availability. All 

meeting sites are barrier free. 

Meeting Registration: The meeting is 

open to the public, but attendance is 

limited to the space available. Persons 

wishing to attend this meeting must 

register by contacting Kodie Ruzicka at 

the e-mail address or telephone number 

listed in the ADDRESSES section of this 

notice by 12 p.m. EST on May 11, 2007. 

For those unable to participate in 

person, audio of the Monday, May 14 

proceedings may be accessed via 

telephone. Please use the above contact 

information for Kodie Ruzicka to obtain 

telephone and passcode information. 

Agenda: PCPID will meet to reappoint 

its members. They will also discuss 

possible content areas for the 2008 

Report to the President and will divide 

into subcommittees for that purpose. 

FOR FURTHER INFORMATION CONTACT: 

Sally D. Atwater, Executive Director, 

President’s Committee for People with 

Intellectual Disabilities, The Aerospace 

Center, Suite 701, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447. Telephone: 202–619–0634, fax: 

202–205–9591. E-mail: 

satwater@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: PCPID 

acts in an advisory capacity to the 

President and the Secretary of Health 

and Human Services on a broad range 

of topics relating to programs, services 

and supports for persons with 

intellectual disabilities. PCPID, by 

Executive Order, is responsible for 

evaluating the adequacy of current 

practices in programs, services and 

supports for persons with intellectual 

disabilities, and for reviewing legislative 

proposals that impact the quality of life 

experienced by citizens with 

intellectual disabilities and their 

families. 

Dated: April 17, 2007. 

Sally D. Atwater, 

Executive Director, President’s Committee for 

People with Intellectual Disabilities. 

[FR Doc. E7–7759 Filed 4–23–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Summaries of Medical and Clinical 

Pharmacology Reviews of Pediatric 

Studies; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of summaries of medical 

and clinical pharmacology reviews of 

pediatric studies submitted in 

supplements for CELEBREX (celecoxib), 

COLAZAL (balsalazide), ELOXATIN 

(oxaliplatin), EMTRIVA (emtricitabine), 

SUPRANE (desflurane), and TOPROL–

XL (metoprolol). These summaries are 

being made available consistent with 

the Best Pharmaceuticals for Children 

Act (the BPCA). For all pediatric 

supplements submitted under the 

BPCA, the BPCA requires FDA to make 

available to the public a summary of the 

medical and clinical pharmacology 

reviews of the pediatric studies 

conducted for the supplement. 

ADDRESSES: Submit written requests for 

single copies of the summaries to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Please specify by 

product name which summary or 

summaries you are requesting. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

summaries. 

FOR FURTHER INFORMATION CONTACT: 

Grace Carmouze, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6460, 

Silver Spring, MD 20993–0002, 301–

796–0700, e-mail: 

grace.carmouze@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

summaries of medical and clinical 

pharmacology reviews of pediatric 

studies conducted for CELEBREX 

(celecoxib), COLAZAL (balsalazide), 

ELOXATIN (oxaliplatin), EMTRIVA 

(emtricitabine), SUPRANE (desflurane), 

and TOPROL–XL (metoprolol). The 

summaries are being made available 

consistent with section 9 of the BPCA 

(Public Law 107–109). Enacted on 

January 4, 2002, the BPCA reauthorizes, 

with certain important changes, the 

pediatric exclusivity program described 

in section 505A of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 355a). Section 505A of the act 

permits certain applications to obtain 6 

months of marketing exclusivity if, in 

accordance with the requirements of the 

statute, the sponsor submits requested 

information relating to the use of the 

drug in the pediatric population. 

One of the provisions the BPCA 

added to the pediatric exclusivity 

program pertains to the dissemination of 

pediatric information. Specifically, for 

all pediatric supplements submitted 

under the BPCA, the BPCA requires 

FDA to make available to the public a 

summary of the medical and clinical 

pharmacology reviews of pediatric 

studies conducted for the supplement 

(21 U.S.C. 355a(m)(1)). The summaries 

are to be made available not later than 

180 days after the report on the 

pediatric study is submitted to FDA (21 

U.S.C. 355a(m)(1)). Consistent with this 

provision of the BPCA, FDA has posted 

on the Internet summaries of medical 

and clinical pharmacology reviews of 

pediatric studies submitted in 

supplements for CELEBREX (celecoxib), 

COLAZAL (balsalazide), ELOXATIN 

(oxaliplatin), EMTRIVA (emtricitabine), 

SUPRANE (desflurane), and TOPROL–

XL (metoprolol). See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries. Copies are also 

available by mail (see ADDRESSES). 


jlentini on PROD1PC65 with NOTICES
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