67620 Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices 

62Network diversity supplemental charge of 

$1,000 a month may apply in addition to these fees. 

By order of the Board of Governors of the 

Federal Reserve System, November 14, 2006. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 06–9333 Filed 11–21–06; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notification and Obligation of the 

Federal Employee Antidiscrimination 

and Retaliation Act of 2002 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

notification and obligation of the 

Federal Employee Antidiscrimination 

and Retaliation Act of 2002 (No Fear 

Act). This notice is in compliance with 

the notification provisions set forth in 

Title II of the Notification and Federal 

Employee Antidiscrimination and 

Retaliation Act of 2002. The No FEAR 

Act requires that all Federal agencies 

publish an initial notice in the Federal 

Register informing Federal employees, 

former Federal employees, and 

applicants of the rights and protections 

available to them under Federal 

antidiscrimination and whistleblower 

protection laws. 

EFFECTIVE DATE: This notice is effective 

on September 18, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Arlene E. Austin, Director, Office of 

Equal Opportunity and Civil Rights, at 

(410) 786–5110 (voice), (410) 786–9549 

(fax), or (410) 786–2456 (TTY); or Anita 

Pinder, Special Assistant, Office of 

Equal Opportunity and Civil Rights, at 

(410) 786–5493 (voice), (410) 786–9549 

(fax), or (410) 786–2456 (TTY) (These 

are not toll free numbers). 

Special Accomodations: This notice 

also is available in the following 

formats: Large print, audio tape, 

electronic file on computer disk, and on 

CMS’s Web page http:// 

www.cms.hhs.gov. Requests for this 

notice in an alternative format should be 

made to CMS’s Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development Group at 1–

800–743–3951 (voice), 1–866–226–1819 

(TTY), or (410) 786–3064 (fax) (The fax 

is not a toll free number). 

Additional Information: For 

additional information regarding the No 

FEAR Act regulations, refer to 5 CFR 

part 724, as well as the appropriate 

offices within your agency (for example, 

Office of Equal Opportunity and Civil 

Rights at 410–786–5110). Additional 

information regarding Federal 

antidiscrimination, whistleblower 

protection, and retaliation laws can be 

found at the EEOC Web site—http:// 

www.eeoc.gov and the OSC Web site—

http://www.osc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On May 15, 2002, the Congress 

enacted the ’’Notification and Federal 

Employee Antidiscrimination and 

Retaliation Act of 2002,’’ which is now 

known as the No FEAR Act. One 

purpose of the Act is to ‘‘require that 

Federal agencies be accountable for 

violations of antidiscrimination and 

whistleblower protection laws.’’ In 

support of this purpose, the Congress 

found that ‘‘agencies cannot be run 

effectively if those agencies practice or 

tolerate discrimination.’’ The No Fear 

Act also requires all agencies to provide 

this notice to Federal employees, former 

Federal employees, and applicants for 

Federal employment to inform 

employees or applicants of the rights 

and protections available under the 

Federal antidiscrimination and 

whistleblower protection laws. 

II. Antidiscrimination Laws 

A Federal agency cannot discriminate 

against an employee or applicant with 

respect to the terms, conditions or 

privileges of employment on the basis of 

race, color, religion, sex, national origin, 

age, disability, marital status or political 

affiliation. Discrimination on these 

bases is prohibited by one or more of the 

following statutes: 5 U.S.C. 2302(b) (1), 

29 U.S.C. 206(d), 29 U.S.C. 631, 29 

U.S.C. 633a, 29 U.S.C. 791, and 42 

U.S.C. 2000e–16. If you believe that you 

have been the victim of unlawful 

discrimination on the basis of race, 

color, religion, sex, national origin, or 

disability, you must contact an Equal 

Employment Opportunity (EEO) 

counselor within 45 calendar days of 

the alleged discriminatory action, or, in 

the case of a personnel action, within 45 

calendar days of the effective date of the 

action, before you can file a formal 

complaint of discrimination with this 

Agency. See, for example, 29 CFR 1614. 

If you believe that you have been the 

victim of unlawful discrimination on 

the basis of age, you must either contact 

an EEO counselor as noted above or give 

notice of intent to sue to the Equal 

Employment Opportunity Commission 

(EEOC) within 180 calendar days of the 

alleged discriminatory action. If you are 

alleging discrimination based on marital 

status or political affiliation, you may 

file a written complaint with the U.S. 

Office of Special Counsel (OSC) (see 

contact information below). In the 

alternative (or in some cases, in 

addition), you may pursue a 

discrimination complaint by filing a 

grievance through this Agency’s 

administrative or negotiated grievance 

procedures, if such procedures apply 

and are available. 

III. Whistleblower Protection Laws 

A Federal employee who has 

authority with respect to personnel 

actions must not take action against an 

employee or applicant because of 

disclosure of information by that 

individual that is reasonably believed to 

evidence violations of law, rule, or 

regulation; gross mismanagement; gross 

waste of funds; an abuse of authority; or 

a substantial and specific danger to 

public health or safety, unless 

disclosure of the information is 

specifically prohibited by law and the 

information is specifically required by 

Executive order to be kept secret in the 

interest of national defense or the 

conduct of foreign affairs. Retaliation 

against an employee or applicant for 

making a protected disclosure is 

prohibited by 5 U.S.C. 2302(b)(8). If you 

believe that you have been the victim of 

whistleblower retaliation, you may file 

a written complaint (Form OSC–11) 

with the U.S. Office of Special Counsel 

at 1730 M Street NW., Suite 218, 

Washington, DC 20036–4505 or online 

through the OSC Web site—http:// 

www.osc.gov. 

IV. Retaliation for Engaging in 

Protected Activity 

A Federal agency cannot retaliate 

against an employee or applicant 

because that individual exercises his or 

her rights under any of the Federal 

antidiscrimination or whistleblower 

protection laws listed above. If you 

believe that you are the victim of 

retaliation for engaging in protected 

activity, you must follow, as 

appropriate, the procedures described in 

the Antidiscrimination Laws and 

Whistleblower Protection Laws sections 

or, if applicable, the administrative or 

negotiated grievance procedures in 

order to pursue any legal remedy. 

V. Disciplinary Actions 

Under the existing laws, each agency 

retains the right, where appropriate, to 

discipline a Federal employee for 

conduct that is inconsistent with 

Federal Antidiscrimination and 


pwalker on PROD1PC61 with NOTICES
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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