Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices 67621 

Whistleblower Protection Laws up to 

and including removal. If OSC has 

initiated an investigation under 5 U.S.C. 

1214, however, according to 5 U.S.C. 

1214(f), agencies must seek approval 

from the Special Counsel to discipline 

employees for, among other activities, 

engaging in prohibited retaliation. 

Nothing in the No FEAR Act alters 

existing laws or permits an agency to 

take unfounded disciplinary action 

against a Federal employee or to violate 

the procedural rights of a Federal 

employee who has been accused of 

discrimination. 

VI. Existing Rights Unchanged 

Pursuant to section 205 of the No 

FEAR Act, neither the Act nor this 

notice creates, expands, or reduces any 

rights otherwise available to any 

employee, former employee, or 

applicant under the laws of the United 

States, including the provisions of law 

specified in 5 U.S.C. 2302(d). 

Authority: Title II of the No FEAR Act, 

Public Law 107–174; 5 CFR Part 724. 

Dated: November 17, 2006. 

Leslie Norwalk, 

Acting Administrator. 

[FR Doc. 06–9361 Filed 11–17–06; 4:32 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0002] 

Guidance for Industry and Food and 

Drug Administration Staff; Saline, 

Silicone Gel, and Alternative Breast 

Implants; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Saline, Silicone Gel, and Alternative 

Breast Implants.’’ This version of the 

guidance document updates preclinical, 

clinical, and labeling recommendations 

described in ‘‘Guidance for Saline, 

Silicone Gel, and Alternative Breast 

Implants,’’ dated January 13, 2004. The 

update is based on the latest scientific 

and medical information on breast 

implants, and clarifies the type and 

amount of scientific data that should be 

submitted to allow FDA to evaluate 

whether these devices are safe and 

effective. 

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 ‘‘Saline, Silicone Gel, and 

Alternative Breast Implants’’ 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 to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Nada Hanafi, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090, ext. 144. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 13, 2004, FDA issued a 

draft guidance document entitled, 

‘‘Saline, Silicone Gel, and Alternative 

Breast Implants’’ to clarify the type and 

amount of scientific data that should be 

submitted to allow FDA to evaluate 

whether these devices are safe and 

effective. The comment period closed 

on April 12, 2004. FDA received over 50 

comments. FDA is now issuing a 

finalized update to this guidance 

document that reflects the latest 

scientific and medical thinking 

pertaining to breast implants, and is 

based on the April 2005 General and 

Restorative Devices Panel meeting, 

FDA’s review of two premarket approval 

applications for silicone gel-filled breast 

implants, and comments received on the 

2004 draft guidance document. The 

primary changes to the guidance 

document since the 2004 draft version 

are to the Mechanical Data, Device 

Explant Analyses (formerly Modes and 

Causes of Rupture), and Core Study 

Clinical Data sections. FDA also 

combined the former two clinical 

sections. Some of the recommendations 

in this guidance document apply to all 

premarket approval applications for 

these devices, while others are specific 

to a type of breast implant (i.e., silicone 

gel-filled, saline-filled, or alternative). 

This guidance document supercedes 

‘‘Guidance for Saline, Silicone Gel, and 

Alternative Breast Implants,’’ dated 

February 11, 2003. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on ‘‘Saline, Silicone 

Gel, and Alternative Breast Implants.’’ 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 ‘‘Saline, Silicone 

Gel, and Alternative Breast Implants,’’

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 240–276–3151 to receive 

a hard copy. Please use the document 

number 1239 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 contains information 

collection provisions that 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 addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 


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67622 Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices 

regulations governing premarket 

approval applications (21 CFR part 814, 

OMB control number 0910–0231). The 

labeling provisions addressed in the 

guidance have been approved by OMB 

under OMB control number 0910–0485. 

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: October 26, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–9325 Filed 11–17–06; 4:30 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0463] 

Draft Guidance for Industry on 

Sinusitis: Designing Clinical 

Development Programs of 

Nonantimicrobial Drugs for Treatment; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Sinusitis: Designing 

Clinical Development Programs of 

Nonantimicrobial Drugs for Treatment.’’

Sinusitis is a common disease affecting 

an estimated 16 percent of the adult 

U.S. population annually. At present, 

other than antimicrobials, the treatment 

options for sinusitis are limited. This 

guidance is intended to assist the 

pharmaceutical industry in designing 

clinical development programs for 

nonantimicrobial drug products for the 

treatment of sinusitis. 

DATES: Submit written or electronic 

comments on the draft guidance by 

January 22, 2007. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Badrul A. Chowdhury, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 3316, 

Silver Spring, MD 20993–0002, 301–

796–2300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Sinusitis: Designing Clinical 

Development Programs of 

Nonantimicrobial Drugs for Treatment.’’

Sinusitis is a disease characterized by 

inflammation of one or more of the 

paranasal sinuses. It is one of the most 

commonly diagnosed diseases in the 

United States affecting an estimated 16 

percent of the adult population 

annually. At present, other than 

antimicrobials, some of which have a 

label indication of acute bacterial 

sinusitis, the treatment options for 

sinusitis are limited. There is an interest 

within the pharmaceutical industry in 

the development of new drugs, 

including drugs other than 

antimicrobials, for the treatment of 

sinusitis. 

This guidance focuses on the 

development of nonantibiotic drugs for 

the treatment of acute sinusitis as well 

as the development of drugs for other 

types of sinusitis. This guidance also 

focuses on the assessment of efficacy in 

phase 3 clinical studies of sinusitis. In 

addition, this guidance addresses 

chemistry, manufacturing, and controls 

issues and pharmacology and toxicology 

issues, because some of the products for 

sinusitis are developed for nasal 

delivery, and there are nuances to nasal 

route of delivery that should be 

considered for appropriate clinical 

study design. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on designing clinical development 

programs of nonantimicrobial drugs for 

the treatment of sinusitis. 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 statutes and regulations. 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: November 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–19689 Filed 11–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Children’s Hospitals Graduate Medical 

Education Payment Program (CHGME 

PP) 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of Children’s Hospitals 

Graduate Medical Education Payment 

Program (CHGME PP) Conference Call. 

SUMMARY: This document announces a 

scheduled CHGME PP conference call 

for Federal fiscal year (FY) 2007. The 

purpose of this conference call is to 

discuss new annual reporting 

requirements as required under Public 

Law (Pub. L.) 109–307 for children’s 

hospitals participating in the CHGME 

PP. 

DATES: The conference call will be held 

on Wednesday, December 6, 2006, from 

2 p.m. to 4 p.m. EST. 


pwalker on PROD1PC61 with NOTICES