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Federal Register / Vol. 72, No.

232 / Tuesday, December 4, 2007 / Proposed Rules 68111

Actions Compliance Procedures

(1) Inspect/check the rudder, aileron, and rud- At whichever occurs first: Follow Cirrus Service Bulletin No. SB 2X–27–
der-aileron interconnect rigging; correct any (i) Within the next 25 hours time-in-serv- 14 R3, Issued: May 9, 2007, Revised: Octo-
out-of-rig condition; and replace the attaching ice (TIS) after the effective date of this ber 10, 2007.
hardware for the rudder-aileron interconnect AD; or
arm. (ii) Within the next 3 months after the ef-
fective date of this AD.
(2) Only if you find an out-of-rig condition: Re- At whichever occurs later: Send the form (Figure 1 of this AD) to FAA,
port to the FAA any out-of-rig conditions dis- (i) Within 10 days after the inspection re- Manufacturing Inspection District Office,
covered as a result of the inspection required quired in paragraph (e)(1) of this AD; 6020 28th Avenue South, Room 103, Min-
by paragraph (e)(1) of this AD on the form in or neapolis, Minnesota, 55450–2700; tele-
Figure 1 of this AD. The Office of Manage- (ii) Within 10 days after the effective date phone (612) 713–4366; facsimile (612)
ment and Budget (OMB) approved the infor- of this AD. 713–4365.
mation contained in this regulation under the
provisions of the Paperwork Reduction Act
and assigned OMB Control Number 2120–

Note: Temporary revisions to the airplane Temporary Revision No. 27–1 and SR22 dated October 10, 2007, contain information
maintenance manuals (AMM), SR20 AMM AMM Temporary Revision No. 27–1, both pertaining to this subject.


[Report only if you find an out-of-rig condition]

1. Inspection Performed By: 2. Telephone:

3. Aircraft Model: 4. Airplane Serial Number:

5. Aircraft Total Hours Time-in-Service: 6. Date of inspection required in paragraph (e)(1) of this AD:

7a. Do any of the aircraft logs contain entries describing flight control 7b. If Yes, copy the log book entry(s) and include the date of the entry.
system maintenance, preventative maintenance, or alteration:

llYes llNo

8. Inspection Results: (Report only if an out-of-rig condition is found, and describe the out-of-rig condition as accurate and detailed as possible):

9. Corrective Action Taken:

Send to:
Federal Aviation Administration
Manufacturing Inspection District Office 6020 28th Avenue South, Room 103
Minneapolis, Minnesota 55450–2700
Telephone (612) 713–4366
Facsimile (612) 713–4365

Alternative Methods of Compliance Corporation, 4515 Taylor Circle, Duluth, DEPARTMENT OF HEALTH AND
(AMOCs) Minnesota 55811; telephone: (218) 727–2737; HUMAN SERVICES
(g) The Manager, Chicago Aircraft Internet address: http://
Certification Office (ACO), FAA, has the www.cirrusdesign.com. To view the AD Food and Drug Administration
authority to approve AMOCs for this AD, if docket, go to the U.S. Department of
requested using the procedures found in 14 Transportation, Docket Operations, M–30,
21 CFR Parts 210 and 211
CFR 39.19. Send information to ATTN: Wess West Building Ground Floor, Room W12–
Rouse, Aerospace Engineer, 2300 East Devon 140, 1200 New Jersey Avenue, SE., [Docket No. 1995N–0362]
Avenue, Room 107, Des Plaines, Illinois Washington, DC 20590, or on the Internet at
60018; telephone: (847) 294–8113; fax: (847) http://dms.dot.gov. The docket number is Current Good Manufacturing Practice;
294–7834. Before using any approved AMOC Docket No. FAA–2007–28246; Directorate Amendment of Certain Requirements
on any airplane to which the AMOC applies, Identifier 2007–CE–048–AD. For Finished Pharmaceuticals;
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notify your appropriate principal inspector Issued in Kansas City, Missouri, on

(PI) in the FAA Flight Standards District November 28, 2007.
Office (FSDO), or lacking a PI, your local AGENCY: Food and Drug Administration,
Patrick R. Mullen,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
ACTION: Proposed rule; withdrawal.
Related Information
(h) To get copies of the service information [FR Doc. E7–23456 Filed 12–3–07; 8:45 am] SUMMARY: The Food and Drug
referenced in this AD, contact Cirrus Design BILLING CODE 4910–13–P Administration (FDA) is announcing the

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68112 Federal Register / Vol. 72, No. 232 / Tuesday, December 4, 2007 / Proposed Rules

withdrawal of a proposed rule pharmaceutical manufacturing quality, We plan to revise the CGMP
published in the Federal Register of the Pharmaceutical CGMPs for the 21st regulations using a more incremental
May 3, 1996 (61 FR 20103) (the May Century initiative (21st Century approach. As part of the FDA’s
1996 proposed rule). The May 1996 initiative). As a part of the 21st Century incremental approach to revising our
proposed rule would have amended initiative, FDA created a CGMP CGMP regulations, we are publishing a
certain requirements of the current good Harmonization Analysis working group direct final rule (and a companion
manufacturing practice (CGMP) to analyze internal and external CGMP proposed rule) elsewhere in this issue of
regulations for finished requirements, including those related to the Federal Register that will, when
pharmaceuticals. These proposed quality systems. The working group finalized, clarify and modernize certain
changes would have clarified certain performed a formal analysis of parts 210 provisions in parts 210 and 211. That
manufacturing, quality control, and and 211 compared with other direct final rule and proposed rule
documentation requirements and would regulations, such as the FDA Medical include some of the minor changes to
have updated the requirements for Device Quality System Requirements, CGMP that were originally proposed in
process and methods validation. In light the FDA Food Hazard Analysis and 1996.
of more recent scientific and technical Critical Control Points requirements, III. Comments on the May 1996
advances and evolving quality systems and the drug GMPs of the European Proposed Rule
and risk management concepts, FDA Union, to identify the differences and
concludes that, at this time, it is consider the value of adding or FDA received approximately 1,500
appropriate to withdraw the May 1996 changing the current regulations in light comments on the May 1996 proposed
proposed rule and newly evaluate the of these more recently developed and rule from 116 pharmaceutical
issues raised in that proposal. related product manufacturing companies, attorneys, consultants, trade
standards. associations, and generic companies.
DATES: The proposed rule is withdrawn
Based on the working group’s The most significant topics on which
on December 4, 2007. FDA received comments are
FOR FURTHER INFORMATION CONTACT: analysis, the agency decided that a
different approach to revising the CGMP summarized as follows:
Mary Malarkey, Center for Biologics • Approximately 298 comments
Evaluation and Research (HFM– regulations was appropriate, and has
addressed the proposed new section on
600), Food and Drug decided to withdraw the proposed rule.
process validation (§ 211.220). The
Administration, 1401 Rockville II. New Approach to Revising FDA’s volume and variety of comments and
Pike, Rockville, MD 20852–1448, CGMP Regulations suggestions indicated to FDA that the
301–827–6190, or new section, as proposed, did not
Dennis Bensley, Center for Veterinary The emphasis of the new approach to
CGMP arising from the 21st Century provide the clarification intended.
Medicine (HFV–140), Food and • Approximately 102 comments were
Drug Administration, 7500 Standish Initiative will be to encourage timely
directed at the proposed changes to
Pl., Rockville, MD 20855, 301–827– detection of and response to emerging
§ 211.110 on sampling and testing of in-
6956, or adverse trends or indications that
process materials and drug products,
Frederick Blumenschein, Center for product quality has been compromised,
which would have added new in-
Drug Evaluation and Research to provide further clarity and modernize
process sampling and validation
(HFD–326), Food and Drug the regulations, and to harmonize
requirements with respect to blend
Administration, 11919 Rockville various aspects of parts 210 and 211
uniformity. The bulk of these comments
Pike, Rockville, MD 20852, 301– both internationally and with other
questioned the need for additional
827–9022. agency regulations.1
testing and sampling requirements in
The agency has determined that the
SUPPLEMENTARY INFORMATION: § 211.110, because other sections of the
current CGMP regulations (parts 210
current rule already require
I. Background and 211) provide a degree of flexibility
scientifically sound sampling plans and
In the Federal Register of May 3, 1996 that will permit the agency to continue
representative samples.
(61 FR 20103), FDA proposed to amend to modernize its approach to regulation • Approximately 112 comments
certain requirements of the CGMP of CGMP. The agency has also discussed proposed revisions to
regulations for finished pharmaceuticals concluded that, as stated in the final § 211.192 on the production, control,
in parts 210 and 211 (21 CFR parts 210 report on the 21st Century initiative, and laboratory review, and investigation
and 211) to clarify certain given this new approach to regulation of of discrepancies. The May 1996
manufacturing, quality control, and pharmaceutical CGMP, it would be proposed rule required written
documentation requirements so that the preferable to revise the CGMP procedures to be established for the
regulations would more accurately regulations in an incremental fashion, review of certain records and
reflect the prevailing CGMP. FDA rather than using the comprehensive investigation of unexplained
received approximately 1,500 comments approach taken in the May 1996 discrepancies. Many of these comments
on the proposed rule. (See section III of proposed rule. After careful recommended that these investigations
this document, Comments on the May consideration, FDA concludes that at and reviews should be used to
1996 Proposed Rule). this time, it is appropriate to withdraw proactively prevent (potential) future
After publication of the May 1996 the May 1996 proposed rule and newly problems rather than being used only to
proposed rule, FDA began to reconsider evaluate the issues raised in that retroactively identify manufacturing
its approach to regulation of CGMP, proposal in the context of more recent discrepancies.
scientific and technical advances and
mstockstill on PROD1PC66 with PROPOSALS

consistent with changes occurring in • A number of comments to the rule

other industries and in other countries. quality systems and risk management were submitted by the compressed
This change in approach is summarized concepts. medical gas industry, which
in the following paragraphs. 1See Pharmaceutical CGMPs for the 21st
communicated concerns regarding the
In August 2002, FDA announced a Century—A Risk Based Approach; Final Report,
applicability to the compressed medical
significant new initiative to enhance September, 2004; available at http://www.fda.gov/ gas industry of the proposed changes to
and modernize regulation of cder/gmp/gmp2004/GMP_finalreport2004.htm. CGMP.

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Federal Register / Vol. 72, No. 232 / Tuesday, December 4, 2007 / Proposed Rules 68113

• Approximately 70 comments were • Federal eRulemaking Portal: http:// Pike, Rockville, MD 20852, 301–
received regarding the proposed new www.regulations.gov. Follow the 827–9022.
§ 211.240 on control of chemical and instructions for submitting comments. SUPPLEMENTARY INFORMATION:
physical contaminants. Many of the • Agency Web site: http://
comments stated that the rule should be www.fda.gov/dockets/ecomments. I. Background
revised to better describe how Follow the instructions for submitting Since the development of the CGMP
contaminants will be identified and to comments on the agency Web site. regulations in 1962, FDA has balanced
provide allowances for threshold levels Written Submissions the need for easily understood
or limits of contaminants. Submit written submissions in the minimum standards with the need to
Overall, the comments were following ways: encourage innovation and the
constructive, informative, and • FAX: 301–827–6870. development of improved
addressed nearly every area of the May • Mail/Hand delivery/Courier [For manufacturing technologies. We strive
1996 proposed rule. Although we do not paper, disk, or CD–ROM submissions]: to give manufacturers latitude to
plan to publish specific responses to Division of Dockets Management (HFA– determine how to achieve the level of
each of these comments, we will take 305), Food and Drug Administration, control necessary for CGMP compliance,
these comments into account as we 5630 Fishers Lane, rm. 1061, Rockville, recognizing that, in some instances,
proceed to make incremental changes to MD 20852. more direction from FDA is necessary to
parts 210 and 211. To ensure more timely processing of provide a uniform standard to the entire
comments, FDA is no longer accepting industry or because of the potential for
IV. Withdrawal of the Proposed Rule harm or the narrow range of acceptable
comments submitted to the agency by e-
For the reasons described in this mail. FDA encourages you to continue means to accomplish a particular CGMP
document, FDA is withdrawing the to submit electronic comments by using objective. FDA periodically reassesses
proposed rule published on May 3, 1996 the Federal eRulemaking Portal or the and revises the CGMP regulations to
(61 FR 20103). agency Web site, as described accommodate advances in technology
Dated: November 26, 2007. previously, in the ADDRESSES portion of that further safeguard the drug
Jeffrey Shuren, this document under Electronic manufacturing process and the public
Submissions. health. As technology and scientific
Assistant Commissioner for Policy.
Instructions: All submissions received knowledge related to CGMP evolve, so
[FR Doc. E7–23271 Filed 12–3–07; 8:45 am] does understanding of the material,
must include the agency name and
Docket No(s). and Regulatory equipment, and process variables, as
Information Number (RIN) (if a RIN well as the operational procedures and
number has been assigned) for this oversight methods that must be defined
DEPARTMENT OF HEALTH AND and controlled to achieve assurance of
HUMAN SERVICES rulemaking. All comments received may
be posted without change to http:// drug product quality.
www.fda.gov/ohrms/dockets/ In 1996, as part of this reassessment
Food and Drug Administration
process, FDA proposed to amend certain
default.htm, including any personal
requirements of the CGMP regulations
21 CFR Parts 210 and 211 information provided. For additional
for finished pharmaceuticals to clarify
information on submitting comments,
[Docket No. 2007N–0280] certain manufacturing, quality control,
see the ‘‘Comments’’ heading of the
and documentation requirements, and
Amendment to the Current Good SUPPLEMENTARY INFORMATION section of
to ensure that the regulations more
Manufacturing Practice Regulations for this document.
accurately encompass current industry
Finished Pharmaceuticals; Companion Docket: For access to the docket to
practice (61 FR 20103, May 3, 1996)
Document to the Direct Final Rule read background documents or
(1996 proposed rule)). Subsequently, as
comments received, go to http://
AGENCY: Food and Drug Administration, a part of the risk-based pharmaceutical
www.fda.gov/ohrms/dockets/ CGMPs for the 21st century initiative,
HHS. default.htm and insert the docket FDA created a CGMP Harmonization
ACTION: Proposed rule. number(s), found in brackets in the Analysis Working Group (CGMP
heading of this document, into the Working Group) to analyze related
SUMMARY: The Food and Drug ‘‘Search’’ box and follow the prompts
Administration (FDA) is publishing this CGMP requirements in effect in the
and/or go to the Division of Dockets United States and internationally,
companion proposed rule to the direct Management, 5630 Fishers Lane, rm.
final rule, published elsewhere in this including those related to quality
1061, Rockville, MD 20852. systems. The CGMP Working Group
issue of the Federal Register, which is
FOR FURTHER INFORMATION CONTACT: compared parts 210 amd 211 (21 CFR
intended to amend certain sections of
the regulations as the first phase of an Mary Malarkey, Center for Biologics parts 210 and 211) with the GMPs of the
incremental approach to modifying the Evaluation and Research (HFM– European Union (EU), as well as other
current good manufacturing practice 600), Food and Drug FDA regulations (e.g., the Quality
(CGMP) regulations for finished Administration, 1401 Rockville Systems Regulation, 21 CFR part 820) to
pharmaceuticals. Pike, Rockville, MD 20852–1448, identify the differences and consider the
301–827–6190, or value of supplementing or changing the
DATES: Submit written or electronic Dennis Bensley, Center for Veterinary current regulations. Based on the CGMP
comments on or before February 19, Medicine (HFV–140), Food and Working Group’s analysis, we decided
mstockstill on PROD1PC66 with PROPOSALS

Drug Administration, 7500 Standish to take an incremental approach to

ADDRESSES: You may submit comments, Pl., Rockville, MD 20855, 301–827– modifying parts 210 and 211 (see http://
identified by Docket No. 2007N–0280, 6956, or www.fda.gov/cder/gmp/gmp2004/
by any of the following methods: Frederick Blumenschein, Center for GMP_finalreport2004.htm#_
Electronic Submissions Drug Evaluation and Research Toc84065744).
Submit electronic comments in the (HFD–326), Food and Drug Because of this change in approach,
following ways: Administration, 11919 Rockville FDA decided not to finalize the 1996

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