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67620 Federal Register / Vol. 71, No.

225 / Wednesday, November 22, 2006 / Notices

Additional Information: For (EEOC) within 180 calendar days of the

By order of the Board of Governors of the additional information regarding the No alleged discriminatory action. If you are
Federal Reserve System, November 14, 2006. FEAR Act regulations, refer to 5 CFR alleging discrimination based on marital
Robert deV. Frierson, part 724, as well as the appropriate status or political affiliation, you may
Deputy Secretary of the Board.
offices within your agency (for example, file a written complaint with the U.S.
Office of Equal Opportunity and Civil Office of Special Counsel (OSC) (see
[FR Doc. 06–9333 Filed 11–21–06; 8:45 am]
Rights at 410–786–5110). Additional contact information below). In the
information regarding Federal alternative (or in some cases, in
antidiscrimination, whistleblower addition), you may pursue a
protection, and retaliation laws can be discrimination complaint by filing a
DEPARTMENT OF HEALTH AND found at the EEOC Web site—http:// grievance through this Agency’s
HUMAN SERVICES and the OSC Web site— administrative or negotiated grievance procedures, if such procedures apply
Centers for Medicare & Medicaid SUPPLEMENTARY INFORMATION: and are available.
I. Background III. Whistleblower Protection Laws
Notification and Obligation of the On May 15, 2002, the Congress A Federal employee who has
Federal Employee Antidiscrimination enacted the ’’Notification and Federal authority with respect to personnel
and Retaliation Act of 2002 Employee Antidiscrimination and actions must not take action against an
AGENCY: Centers for Medicare & Retaliation Act of 2002,’’ which is now employee or applicant because of
Medicaid Services (CMS), HHS. known as the No FEAR Act. One disclosure of information by that
purpose of the Act is to ‘‘require that individual that is reasonably believed to
ACTION: Notice. evidence violations of law, rule, or
Federal agencies be accountable for
SUMMARY: This notice announces the violations of antidiscrimination and regulation; gross mismanagement; gross
notification and obligation of the whistleblower protection laws.’’ In waste of funds; an abuse of authority; or
Federal Employee Antidiscrimination support of this purpose, the Congress a substantial and specific danger to
and Retaliation Act of 2002 (No Fear found that ‘‘agencies cannot be run public health or safety, unless
Act). This notice is in compliance with effectively if those agencies practice or disclosure of the information is
the notification provisions set forth in tolerate discrimination.’’ The No Fear specifically prohibited by law and the
Title II of the Notification and Federal Act also requires all agencies to provide information is specifically required by
Employee Antidiscrimination and this notice to Federal employees, former Executive order to be kept secret in the
Retaliation Act of 2002. The No FEAR Federal employees, and applicants for interest of national defense or the
Act requires that all Federal agencies Federal employment to inform conduct of foreign affairs. Retaliation
publish an initial notice in the Federal employees or applicants of the rights against an employee or applicant for
Register informing Federal employees, and protections available under the making a protected disclosure is
former Federal employees, and Federal antidiscrimination and prohibited by 5 U.S.C. 2302(b)(8). If you
applicants of the rights and protections whistleblower protection laws. believe that you have been the victim of
available to them under Federal whistleblower retaliation, you may file
II. Antidiscrimination Laws
antidiscrimination and whistleblower a written complaint (Form OSC–11)
A Federal agency cannot discriminate with the U.S. Office of Special Counsel
protection laws. against an employee or applicant with at 1730 M Street NW., Suite 218,
EFFECTIVE DATE: This notice is effective respect to the terms, conditions or Washington, DC 20036–4505 or online
on September 18, 2006. privileges of employment on the basis of through the OSC Web site—http://
FOR FURTHER INFORMATION CONTACT: race, color, religion, sex, national origin,
Arlene E. Austin, Director, Office of age, disability, marital status or political
Equal Opportunity and Civil Rights, at affiliation. Discrimination on these IV. Retaliation for Engaging in
(410) 786–5110 (voice), (410) 786–9549 bases is prohibited by one or more of the Protected Activity
(fax), or (410) 786–2456 (TTY); or Anita following statutes: 5 U.S.C. 2302(b) (1), A Federal agency cannot retaliate
Pinder, Special Assistant, Office of 29 U.S.C. 206(d), 29 U.S.C. 631, 29 against an employee or applicant
Equal Opportunity and Civil Rights, at U.S.C. 633a, 29 U.S.C. 791, and 42 because that individual exercises his or
(410) 786–5493 (voice), (410) 786–9549 U.S.C. 2000e–16. If you believe that you her rights under any of the Federal
(fax), or (410) 786–2456 (TTY) (These have been the victim of unlawful antidiscrimination or whistleblower
are not toll free numbers). discrimination on the basis of race, protection laws listed above. If you
Special Accomodations: This notice color, religion, sex, national origin, or believe that you are the victim of
also is available in the following disability, you must contact an Equal retaliation for engaging in protected
formats: Large print, audio tape, Employment Opportunity (EEO) activity, you must follow, as
electronic file on computer disk, and on counselor within 45 calendar days of appropriate, the procedures described in
CMS’s Web page http:// the alleged discriminatory action, or, in the Antidiscrimination Laws and Requests for this the case of a personnel action, within 45 Whistleblower Protection Laws sections
notice in an alternative format should be calendar days of the effective date of the or, if applicable, the administrative or
made to CMS’s Office of Strategic action, before you can file a formal negotiated grievance procedures in
Operations and Regulatory Affairs, complaint of discrimination with this order to pursue any legal remedy.
Regulations Development Group at 1– Agency. See, for example, 29 CFR 1614.
If you believe that you have been the V. Disciplinary Actions
800–743–3951 (voice), 1–866–226–1819
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(TTY), or (410) 786–3064 (fax) (The fax victim of unlawful discrimination on Under the existing laws, each agency
is not a toll free number). the basis of age, you must either contact retains the right, where appropriate, to
an EEO counselor as noted above or give discipline a Federal employee for
62 Network diversity supplemental charge of notice of intent to sue to the Equal conduct that is inconsistent with
$1,000 a month may apply in addition to these fees. Employment Opportunity Commission Federal Antidiscrimination and

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

Whistleblower Protection Laws up to General comments on agency guidance to a type of breast implant (i.e., silicone
and including removal. If OSC has documents are welcome at any time. gel-filled, saline-filled, or alternative).
initiated an investigation under 5 U.S.C. ADDRESSES: Submit written requests for This guidance document supercedes
1214, however, according to 5 U.S.C. single copies of the guidance document ‘‘Guidance for Saline, Silicone Gel, and
1214(f), agencies must seek approval entitled ‘‘Saline, Silicone Gel, and Alternative Breast Implants,’’ dated
from the Special Counsel to discipline Alternative Breast Implants’’ to the February 11, 2003.
employees for, among other activities, Division of Small Manufacturers, II. Significance of Guidance
engaging in prohibited retaliation. International, and Consumer Assistance
Nothing in the No FEAR Act alters (HFZ–220), Center for Devices and This guidance is being issued
existing laws or permits an agency to Radiological Health, Food and Drug consistent with FDA’s good guidance
take unfounded disciplinary action Administration, 1350 Piccard Dr., practices regulation (21 CFR 10.115).
against a Federal employee or to violate Rockville, MD 20850. Send one self- The guidance represents the agency’s
the procedural rights of a Federal addressed adhesive label to assist that current thinking on ‘‘Saline, Silicone
employee who has been accused of office in processing your request, or fax Gel, and Alternative Breast Implants.’’ It
discrimination. does not create or confer any rights for
your request to 240–276–3151. See the
or on any person and does not operate
VI. Existing Rights Unchanged SUPPLEMENTARY INFORMATION section for
to bind FDA or the public. An
information on electronic access to the
Pursuant to section 205 of the No alternative approach may be used if
FEAR Act, neither the Act nor this Submit written comments concerning such approach satisfies the
notice creates, expands, or reduces any this guidance to the Division of Dockets requirements of the applicable statute
rights otherwise available to any Management (HFA–305), Food and Drug and regulations.
employee, former employee, or Administration, 5630 Fishers Lane, rm. III. Electronic Access
applicant under the laws of the United 1061, Rockville, MD 20852. Submit
States, including the provisions of law Persons interested in obtaining a copy
electronic comments to http:// of the guidance may do so by using the
specified in 5 U.S.C. 2302(d). Internet. To receive ‘‘Saline, Silicone
Authority: Title II of the No FEAR Act, Identify comments with the docket Gel, and Alternative Breast Implants,’’
Public Law 107–174; 5 CFR Part 724. number found in brackets in the you may either send an e-mail request
Dated: November 17, 2006. heading of this document. to to receive an
Leslie Norwalk, FOR FURTHER INFORMATION CONTACT: electronic copy of the document or send
Acting Administrator. Nada Hanafi, Center for Devices and a fax request to 240–276–3151 to receive
[FR Doc. 06–9361 Filed 11–17–06; 4:32 pm]
Radiological Health (HFZ–410), Food a hard copy. Please use the document
and Drug Administration, 9200 number 1239 to identify the guidance
Corporate Blvd., Rockville, MD 20850, you are requesting.
301–594–3090, ext. 144. CDRH maintains an entry on the
HUMAN SERVICES including text, graphics, and files that
I. Background
may be downloaded to a personal
Food and Drug Administration On January 13, 2004, FDA issued a computer with Internet access. Updated
draft guidance document entitled, on a regular basis, the CDRH home page
[Docket No. 2004D–0002]
‘‘Saline, Silicone Gel, and Alternative includes device safety alerts, Federal
Guidance for Industry and Food and Breast Implants’’ to clarify the type and Register reprints, information on
Drug Administration Staff; Saline, amount of scientific data that should be premarket submissions (including lists
Silicone Gel, and Alternative Breast submitted to allow FDA to evaluate of approved applications and
Implants; Availability whether these devices are safe and manufacturers’ addresses), small
effective. The comment period closed manufacturer’s assistance, information
AGENCY: Food and Drug Administration, on April 12, 2004. FDA received over 50 on video conferencing and electronic
HHS. comments. FDA is now issuing a submissions, Mammography Matters,
ACTION: Notice. finalized update to this guidance and other device-oriented information.
document that reflects the latest The CDRH web site may be accessed at
SUMMARY: The Food and Drug scientific and medical thinking A search
Administration (FDA) is announcing the pertaining to breast implants, and is capability for all CDRH guidance
availability of the guidance entitled based on the April 2005 General and documents is available at http://
‘‘Saline, Silicone Gel, and Alternative Restorative Devices Panel meeting,
Breast Implants.’’ This version of the FDA’s review of two premarket approval Guidance documents are also available
guidance document updates preclinical, applications for silicone gel-filled breast on the Division of Dockets Management
clinical, and labeling recommendations implants, and comments received on the Internet site at
described in ‘‘Guidance for Saline, 2004 draft guidance document. The ohrms/dockets.
Silicone Gel, and Alternative Breast primary changes to the guidance
Implants,’’ dated January 13, 2004. The document since the 2004 draft version IV. Paperwork Reduction Act of 1995
update is based on the latest scientific are to the Mechanical Data, Device This guidance contains information
and medical information on breast Explant Analyses (formerly Modes and collection provisions that are subject to
implants, and clarifies the type and Causes of Rupture), and Core Study review by the Office of Management and
amount of scientific data that should be Clinical Data sections. FDA also Budget (OMB) under the Paperwork
pwalker on PROD1PC61 with NOTICES

submitted to allow FDA to evaluate combined the former two clinical Reduction Act of 1995 (the PRA) (44
whether these devices are safe and sections. Some of the recommendations U.S.C. 3501–3520). The collections of
effective. in this guidance document apply to all information addressed in the guidance
DATES: Submit written or electronic premarket approval applications for document have been approved by OMB
comments on this guidance at any time. these devices, while others are specific in accordance with the PRA under the

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