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57980 Federal Register / Vol. 71, No.

190 / Monday, October 2, 2006 / Notices

DEPARTMENT OF HEALTH AND Administration, 11919 Rockville • The agency’s orientation must be
HUMAN SERVICES Pike, Rockville, MD 20852, 301– toward integrated quality systems,
827–9047; • International cooperation is very
Food and Drug Administration Robert Sausville, Center for Biologics important, and
[Docket No. 2004D–0443] Evaluation and Research (HFM– • Protection of the public health must
610), Food and Drug remain the top priority.
Guidance for Industry on Quality Administration, 1401 Rockville The initiative’s announcement stated
Systems Approach to Pharmaceutical Pike, Rockville, MD 20852–1448, that 21 CFR parts 210, 211, 600, and 610
Current Good Manufacturing Practice 301–827–6205; are flexible and will allow the agency to
Regulations; Availability June Liang, Center for Veterinary embark on a science-based risk
Medicine (HFV–143), Food and management approach to CGMPs. This
AGENCY: Food and Drug Administration, Drug Administration, 7500 Standish guidance, developed by a cross-center
HHS. Pl., Rockville, MD 20855, 301–827– working group established by the
ACTION: Notice. 8789; or initiative, is key in achieving the
Patricia Maroney Benassi, Office of agency’s goals. By showing how modern
SUMMARY: The Food and Drug
Regulatory Affairs (HFC–240), quality systems approaches relate to the
Administration (FDA) is announcing the 15800 Crabbs Branch Way,
availability of a guidance for industry existing CGMP regulations, the agency
Rockville MD 20855, 240–632– can help manufacturers meet the
entitled ‘‘Quality Systems Approach to 6819.
Pharmaceutical Current Good requirements of the agency’s CGMPs
Manufacturing Practice Regulations.’’ SUPPLEMENTARY INFORMATION: while using a robust quality systems
This guidance explains FDA’s current approach to the production of human
I. Background and animal medical products. Such a
thinking regarding advances that have
been made in the quality and FDA is announcing the availability of comprehensive approach should foster
manufacturing sciences since the a guidance for industry entitled flexibility and allow for continued
current good manufacturing practice ‘‘Quality Systems Approach to innovation, while maintaining the
(CGMP) regulations were issued in Pharmaceutical Current Good principles of the CGMP regulations.
1978. The guidance describes the key Manufacturing Practice Regulations.’’ On October 4, 2004, FDA issued a
elements of a robust quality systems This guidance was developed by the draft of this guidance (69 FR 59256).
model and shows how persons quality systems working group formed Comments were received and
implementing such a model can achieve as part of the Pharmaceutical CGMPs for considered carefully as the agency
compliance with the CGMP regulations. the 21st Century: A Risk Based finalized the guidance. No substantive
Approach initiative (the initiative) now changes were made to the final
DATES: Submit written or electronic
the Council on Pharmaceutical Quality. guidance, although a number of
comments on agency guidances at any
The guidance is intended to encourage clarifying edits were made throughout
time.
the use of modern quality management the guidance based on the comments
ADDRESSES: Submit written requests for system principles by the regulated received. In addition, the reference list
single copies of the guidance to the industry and foster innovation and and the graphic depicting a quality
Division of Drug Information (HFD– continuous improvements in management systems approach were
240), Center for Drug Evaluation and pharmaceutical manufacturing. The updated.
Research, Food and Drug initiative was announced in August This guidance is being issued
Administration, 5600 Fishers Lane, 2002 (http://www.fda.gov/cder/gmp/ consistent with FDA’s good guidance
Rockville, MD 20857, or the Office of 2ndprogressrept_plan.htm). Among the practices regulation (21 CFR 10.115).
Communication, Training, and many issues identified at that time were: The guidance represents the agency’s
Manufacturers Assistance (HFM–40), (1) The increase in the number of current thinking on a quality systems
Center for Biologics Evaluation and pharmaceutical products and in the role approach to pharmaceutical CGMP
Research, Food and Drug of medicines in health care; (2) the regulations. It does not create or confer
Administration, 1401 Rockville Pike, decrease in the frequency of FDA any rights for or on any person and does
suite 200N, Rockville, MD 20852–1448. manufacturing inspections resulting not operate to bind FDA or the public.
Send one self-addressed adhesive label from fewer resources available for An alternative approach may be used if
to assist that office in processing your pharmaceutical manufacturing such approach satisfies the
requests. The guidance may also be inspections; (3) FDA’s increasing requirements of the applicable statutes
obtained by mail by calling the CBER experience with, and lessons learned and regulations.
Voice Information System at 1–800– from, various approaches to the
835–4709 or 301–827–1800. See the II. Comments
regulation of product quality; (4)
SUPPLEMENTARY INFORMATION section for advances in the pharmaceutical sciences Interested persons may submit to the
electronic access to the guidance and manufacturing technologies; (5) the Division of Dockets Management (see
document. increasing application of biotechnology ADDRESSES) written or electronic
Submit written comments on the in drug discovery and manufacturing; comments regarding this document.
guidance to the Division of Dockets (6) advances in the science and Submit a single copy of electronic
Management (HFA–305), Food and Drug management of quality; and (7) the comments or two paper copies of any
Administration, 5630 Fishers Lane, rm. globalization of the pharmaceutical mailed comments, except that
1061, Rockville, MD 20852. Submit industry. individuals may submit one paper copy.
electronic comments to http://
rmajette on PROD1PC67 with NOTICES1

At the outset, the agency established Comments are to be identified with the
www.fda.gov/dockets/ecomments. a set of guiding principles for the docket number found in brackets in the
FOR FURTHER INFORMATION CONTACT: initiative: heading of this document. Received
Monica Caphart, Center for Drug • Maintain a risk-based orientation, comments may be seen in the Division
Evaluation and Research (HFD– • Policies and standards must be of Dockets Management between 9 a.m.
320), Food and Drug science-based, and 4 p.m., Monday through Friday.

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Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices 57981

III. Electronic Access Resources and Services Administration, functions at or below marketplace cost
Persons with access to the Internet 5600 Fishers Lane, 7C–22, Rockville, to their members to increase
may obtain the document at either Maryland 20857; telephone number: efficiencies, reduce costs, and improve
http://www.fda.gov/cder/guidance/ 301–594–4472; fax number: 301–443– health care quality for underserved and
index.htm or http://www.fda.gov/ 1330. uninsured populations. As such, the
ohrms/dockets/default.htm. SUPPLEMENTARY INFORMATION: In HCCNs are key to achieving the
accordance with Public Health Service President’s goal of assuring that every
Dated: September 7, 2006.
Act, Title III, Section 330(e)(1)(C), 42 American in the Nation will have an
Jeffrey Shuren, electronic health record by 2014.
U.S.C.254b (as amended).
Assistant Commissioner for Policy.
[FR Doc. E6–16215 Filed 9–29–06; 8:45 am] Background Justification for the Exception to
BILLING CODE 4160–01–S OHIT serves as the HRSA Competition
Administrator’s principal advisor for The creation of OHIT was part of
promoting the adoption of and HRSA’s new priorities related to HIT
DEPARTMENT OF HEALTH AND implementing health care information
HUMAN SERVICES and it is necessary that HRSA have an
technology for the medically uninsured, opportunity to ensure that its new HIT
underserved and other vulnerable strategy and resources are reflected in
Health Resources and Services populations, ensuring that key issues
Administration its grant programs. Because OHIT was
affecting the public and private
just established on December 27, 2005,
adoption of health information
Notification of a Class Deviation of and only became fully staffed in May
technology are addressed (e.g., privacy
Grants Policy Directive Part 2.04 2006, there has been inadequate time to
and security issues, standardization,
develop a new strategy to promote HIT
AGENCY: Health Resources and Services and interoperability). The HCCNs are
key partners in enabling HRSA to help in the safety net community and to
Administration (HRSA), HHS.
adopt and implement the President’s establish funding priorities that are in
ACTION: Notice.
Health Information Technology line with the new office’s goals.
SUMMARY: In accordance with the Grants Initiative in the safety net community. The OHIT has granted 18 HCCN
Policy Directive Part 1.03, the Office of The HCCNs support the creation, grants a one-time 12-month extension
Health Information Technology (OHIT) development, and operation of networks (with funds) of the current budget
has been granted a class deviation from of safety net providers to ensure access period, which expires August 31, 2006.
the competition requirements contained to health care for the medically This will avoid disruption of the HCCNs
in the Grants Policy Directive Part 2.04 underserved populations through the infrastructure and any impairment to
to provide an additional year of funding enhancement of health center the accomplishment of their work plans
without competition for Health Center operations. The HCCNs routinely that would likely result from a
Controlled Network (HCCN) Initiatives perform core business functions for competitive reallocation of funds
funded under Section 330 of the Public their safety net members across their without careful planning and advanced
Health Service Act, as amended. marketplace, State, or region. The core notice. All future funding for these
FOR FURTHER INFORMATION CONTACT: business functions range from electronic activities will be based on a full and
Susan Lumsden, Director, Division of health records, credentialing and open competition that will focus on the
Health Information Technology State privileging programs, utilization review most effective utilization of available
and Community Assistance, Office of and management, and clinical quality resources in support of the
Health Information Technology, Health improvement. They provide these Administration’s new HIT objectives.

12 month
Grantee name State extension

South Cove CHC, Inc. .............................................................................................................................................................. MA .... $86,788


SW Virginia Community Health System ................................................................................................................................... VA ..... 57,859
Keystone Rural Health Center .................................................................................................................................................. PA ..... 70,611
Aaron E. Henry CHC ................................................................................................................................................................ MS .... 57,859
Cook Area Health Services ...................................................................................................................................................... MN .... 62,487
Horizon Health Care, Inc. ......................................................................................................................................................... SD .... 86,788
Mariposa Community Health Center ........................................................................................................................................ AZ ..... 57,859
Asian Health Services ............................................................................................................................................................... CA .... 86,788
Southwest Virginia Community Health ..................................................................................................................................... VA ..... 167,742
Health Choice Network ............................................................................................................................................................. FL ..... 173,576
Neighborhood Health Care Network ......................................................................................................................................... MN .... 173,576
Central Oklahoma Integrated Network System ........................................................................................................................ OK .... 88,900
Colorado Community Managed Care Network ......................................................................................................................... CO .... 128,646
Community Health Center Network .......................................................................................................................................... CA .... 173,576
Klamath Health Partnership ...................................................................................................................................................... OR .... 173,576
Collier Health Services, Inc. ..................................................................................................................................................... FL ..... 82,237
Wasatch Homeless Health Care, Inc. ...................................................................................................................................... UT ..... 159,111
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Oregon Primary Care Association ............................................................................................................................................ OR .... 162,022

2,050,000

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