Supplements and Other Changes to an Approved Application; Public Meeting, 574-576 [E6-22588]
Download as PDF
574
Federal Register / Vol. 72, No. 3 / Friday, January 5, 2007 / Notices
normalization factors between FY 2006 and
FY 2007.
Note: If there is no value or dashes (that
is, ‘‘----’’) in either the geometric mean LOS
or the arithmetic mean LOS columns, the
volume of cases is insufficient to determine
a meaningful computation of these statistics.
IV. Discussion of Effective Date and
Notice and Comment Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). In addition,
a final rule would ordinarily require a
30-day delay in effective date after the
date of publication in the Federal
Register. This correction of the rates
published in the FY 2007 IPPS notice
does not constitute a rule under the
Administrative Procedure Act, because,
in our FY 2007 IPPS final rule (71 FR
47870, August 18, 2006), we already
published the methodologies and
formulas we use for determining the
wage index, geographic adjustment
factors, and other rates. This notice does
not change our methodology or
formulas, but merely ensures that our
rules are implemented correctly. As this
notice is not a rule under the
Administrative Procedure Act, no notice
of proposed rulemaking or delay in
effective date is necessary.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.)
Dated: December 28, 2006.
Ashley Files Flory,
Deputy Executive Secretary to the
Department.
[FR Doc. 06–9976 Filed 12–29–06; 1:29 pm]
regarding chemistry, manufacturing,
and controls (CMC) supplements and
other changes to approved marketing
applications for human drugs. FDA is
evaluating how it could revise its
regulations to allow for consideration of
risk-based approaches based on
manufacturing process understanding,
including prior knowledge of similar
products, and overall quality systems to
provide an enhanced risk-based
approach to the CMC regulatory process,
which would reduce the number of
supplements. We will consider the
input from the public meeting and
comments on the issues presented in
this document as we consider whether
to revise our regulations.
DATES: The public meeting will be held
on February 7, 2007, from 8:30 a.m. to
3:30 p.m. Anyone who wishes to speak
at the meeting must register and submit
a summary of the presentation by
January 24, 2007, and submit an
electronic copy of the presentation by
January 31, 2007. See section III of the
SUPPLEMENTARY INFORMATION section of
this document for details on how to
register. Submit written or electronic
comments by March 7, 2007.
ADDRESSES: The public meeting will be
held at the Food and Drug
Administration, Center for Drug
Evaluation and Research Conference
Room, 7519 Standish Pl., third floor, rm.
A, Rockville, MD 20855. There is
parking near the building. Photo
identification is required to clear
building security.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/
ecomments.
FOR FURTHER INFORMATION CONTACT:
David J. Cummings, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 3525,
Rockville, MD 20993–0002, 301–796–
2400, e-mail:
David.Cummings@fda.hhs.gov.
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0525]
SUPPLEMENTARY INFORMATION:
Supplements and Other Changes to an
Approved Application; Public Meeting
I. Background
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice of public meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to solicit comments on
issues that FDA should consider when
developing revisions to its regulations
VerDate Aug<31>2005
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In the Federal Register of June 28,
1999 (64 FR 34608), FDA published a
proposed rule to implement section 116
of the Food and Drug Administration
Modernization Act (FDAMA)1 by
1 Section 116 of FDAMA (Public Law 105–115)
amended the Federal Food, Drug, and Cosmetic Act
(FDCA) by adding section 506A (21 U.S.C. 356a),
which describes requirements and procedures for
making and reporting manufacturing changes to
PO 00000
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Fmt 4703
Sfmt 4703
amending certain regulations including
§ 314.70 (21 CFR 314.70) regarding
supplements and other changes to
approved human new drug and
abbreviated new drug marketing
applications. In the Federal Register of
April 8, 2004 (69 FR 18728), FDA
published the final rule (final rule)
implementing these changes. Section
314.70, as amended, requires
manufacturers to assess the effects of
manufacturing changes on the identity,
strength, quality, purity, and potency of
a drug as those factors relate to the
safety or effectiveness of the product,
and categorizes all changes beyond the
established variations in an approved
NDA or ANDA into one of three
groups—major, moderate, or minor.
Major changes require an applicant to
submit and receive FDA approval of a
supplement before distribution of the
product made with the manufacturing
change. Moderate changes require an
applicant to submit a supplement at
least 30 days before distribution of the
product or, in some cases, submit a
supplement at the time of distribution.
Minor changes require an applicant to
notify FDA of the changes in an annual
report.
In August 2002, FDA introduced the
Pharmaceutical Current Good
Manufacturing Practices (CGMPs) for
the 21st Century Initiative (CGMP
Initiative, available on the Internet at
https://www.fda.gov/cder/gmp/
index.htm) to enhance and modernize
the regulation of pharmaceutical
manufacturing and product quality. In
September 2004 (after publication of the
final rule), FDA published a final report
on ‘‘Pharmaceutical CGMPs for the 21st
Century—A Risk-Based Approach’’
(https://www.fda.gov/cder/gmp/
gmp2004/GMP_finalreport2004.htm).
As explained in the report, FDA
regulates pharmaceutical manufacturing
to ensure that the drug supply in the
United States is of consistently high
quality. Because of critical public health
implications of drug manufacturing,
FDA traditionally has exercised
extensive control over virtually every
aspect of the manufacturing process.
This regulatory approach has
contributed to pharmaceutical
companies being reluctant to change
their manufacturing processes and
equipment. In recent years, significant
advances in pharmaceutical
manufacturing science, modern quality
management systems, and risk
management approaches have taken
place. This has yielded new tools that
certain approved marketing applications, including
new drug applications (NDAs) and abbreviated new
drug applications (ANDAs).
E:\FR\FM\05JAN1.SGM
05JAN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 3 / Friday, January 5, 2007 / Notices
can be used to help ensure
manufacturing quality. The new tools
enable manufacturers to detect, analyze,
correct, and prevent problems and
continuously improve their
manufacturing processes. It has been the
goal of the CGMP Initiative to create a
regulatory paradigm that will encourage
pharmaceutical manufacturers to use
these new tools to facilitate their
decision making and implementation of
manufacturing processes to reliably
produce pharmaceuticals of high
quality. Under the new paradigm, as
under the current scheme,
pharmaceutical manufacturers are
ultimately responsible for ensuring the
quality of their products subject to FDA
regulatory oversight.
The current § 314.70 categorizes
postapproval CMC changes and their
associated reporting requirements
without consideration of the applicant’s
risk management activities or internal
quality systems and practices; therefore,
§ 314.70 reflects a rules-based, or
prescriptive, approach to regulating
postapproval manufacturing changes.
The current § 314.70 may create
regulatory burdens and costs that
discourage beneficial manufacturing
changes and may not support a
desirable level of innovation,
modernization, and flexibility for the
industry as described in the CGMP
Initiative.
Consistent with the agency’s riskbased approach to regulating
pharmaceutical manufacturing
described in the CGMP Initiative, FDA
is considering possible revisions to
§ 314.70. In particular, FDA is
evaluating how it could revise § 314.70
to allow for more manufacturing
changes to be made without prior FDA
approval using a firm’s internal change
control system. FDA also is evaluating
how it could revise § 314.70 to allow for
consideration of risk-based approaches
based on manufacturing process
understanding, including prior
knowledge of similar products, and
overall quality systems to provide an
enhanced risk-based approach to the
CMC regulatory process. To accomplish
this objective, FDA is considering
redefining what FDA considers to be a
major manufacturing change, reducing
the reporting burden for certain
changes, and creating a new reporting
category of manufacturing changes that
do not require notification to FDA. FDA
anticipates that these revisions would
reduce the number of postapproval
supplements that are required to be
submitted. We emphasize that under a
new regulatory scheme, although the
reporting burdens for certain
manufacturing changes would be
VerDate Aug<31>2005
17:29 Jan 04, 2007
Jkt 211001
reduced, manufacturers will continue to
be responsible for ensuring product
quality. FDA also is considering an
approach that would retain aspects of
the current regulatory scheme to
accommodate those manufacturers who
choose to continue operating within the
current regulatory framework. FDA is
announcing this public meeting to
solicit comments on issues that should
be considered if FDA decides to propose
revisions to § 314.70.
II. Questions for Discussion and
Comment
FDA has prepared the following
questions to help focus the comments
that will be presented at the public
meeting or otherwise communicated to
the agency. Those who comment are
invited to address any or all of these
questions, or raise other issues.
1. Is it valuable for the agency to move
toward a more risk-based and quality
systems oriented strategy for regulating
postapproval CMC changes outside of
the formal application review process?
What are the advantages and/or
disadvantages?
2. Would revising § 314.70 as
described in this notice provide the
same level of protection to the public as
the current regulatory scheme with
respect to ensuring the safety and
efficacy of human drugs? What
inspectional approaches might the
agency consider to evaluate
manufacturing changes while ensuring
public safety?
3. Would revising § 314.70 as
described in this notice change the
regulatory burden on the
pharmaceutical industry? If so, how
would the burden change?
4. Would reducing the
prescriptiveness of § 314.70 provide
manufacturers with greater regulatory
flexibility? Would it encourage
manufacturers to adopt CMC-related
risk management strategies? Would
there be disadvantages?
III. Registration, Agenda, and
Transcript
Seating is limited and will be
available on a first-come, first-served
basis. If you need special
accommodations because of a disability,
please inform David J. Cummings.
Registration for Speaking Attendees:
If you wish to make an oral presentation
at the meeting, you must register and
submit a summary of your presentation
to David J. Cummings by January 24,
2007, via e-mail to:
David.Cummings@fda.hhs.gov. When
registering, you must provide the
following information: (1) The specific
topic or issue to be addressed; (2) your
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575
name, title, company or organization,
address, phone number, and e-mail
address; and (3) the approximate time
requested to speak. FDA encourages
persons and groups having similar
interests to consolidate their
information for presentation through a
single representative. After reviewing
the requests to present, we will notify
each participant by e-mail or telephone
of the amount of time allotted and the
approximate time the participant’s
presentation is scheduled to begin.
Presenters must send electronic copies
of their presentations in Microsoft
PowerPoint, Microsoft Word, or Adobe
Portable Document Format (PDF) to
David J. Cummings by noon on January
31, 2007.
Agenda and Transcript: The agenda
for the public meeting will be available
February 2, 2006, on FDA’s Center for
Drug Evaluation and Research (CDER)
Web site at: https://www.fda.gov/cder/
meeting/OPS_20070207.htm. After the
meeting, the agenda, presentations, and
transcript will be placed on file in the
Division of Dockets Management (see
ADDRESSES) under the docket number
found in the heading of this document
and on CDER’s Web site identified
previously.
You may examine the meeting
transcript Monday through Friday
between 9 a.m. and 4 p.m. in the
Division of Dockets Management Public
Reading Room (see ADDRESSES) and on
the Internet at https://www.fda.gov/
ohrms/dockets/default.htm. You may
also request a copy of the transcript
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 20 working days after the
meeting at a cost of 10 cents per page
or on compact disc at a cost of $14.25
each.
IV. Comments
Regardless of attendance at the
meeting, interested persons may submit
to the Division of Dockets Management
(see ADDRESSES) written or electronic
comments related to the questions and
the focus of this public meeting by
March 7, 2007. All relevant data and
information should be submitted with
the written comments. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The received comments are
available for public examination in the
Division of Dockets Management
E:\FR\FM\05JAN1.SGM
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Federal Register / Vol. 72, No. 3 / Friday, January 5, 2007 / Notices
other forms of information technology,
e.g., permitting electronic submissions
of responses.
FOR FURTHER INFORMATION CONTACT:
Steve Yonkers, 202–298–5200 (this is
not a toll free number).
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–22588 Filed 1–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
United States Visitor and Immigrant
Status Indicator Technology (US–
VISIT)
sroberts on PROD1PC70 with NOTICES
AGENCY: US–VISIT, Department of
Homeland Security.
ACTION: Submission for OMB review;
comment request.
SUMMARY: The Department of Homeland
Security, US–VISIT Program, has
submitted the following information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995 (Pub. L. 104–13, 44 U.S.C. Chapter
35). A copy of this ICR, with applicable
supporting documentation, may be
obtained by calling Steve Yonkers, 202–
298–5200 (this is not a toll free number).
DATES: Comments are encouraged and
will be accepted until March 6, 2007.
This process is conducted in accordance
with 5 CFR 1320.10.
ADDRESSES: Comments and questions
about this Information Collection
Request should be forwarded to the
Office of Information and Regulatory
Affairs, Attn: OMB Desk Officer for the
Department of Homeland Security,
Office of Management and Budget,
Room 10235, Washington, DC 20503.
The Office of Management and Budget
is particularly interested in comments
which:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
VerDate Aug<31>2005
17:29 Jan 04, 2007
Jkt 211001
Analysis
Agency: Department of Homeland
Security, US–VISIT Program.
Title: US–VISIT Program.
OMB Number: 1600–0006.
Frequency: One-time collection.
Affected Public: Foreign visitors into
the U.S.
Number of Respondents: 156,732,442.
Estimated Time Per Respondent: 15
seconds.
Total Burden Hours: 658,276 hours.
Total Burden Cost (capital/startup):
$0.00.
Total Burden Cost (operating/
maintaining): $0.00.
Description: The United States Visitor
and Immigrant Status Indicator
Technology (US–VISIT) is a program
established by the Department of
Homeland Security (DHS) to meet
specific legislative mandates intended
to strengthen border security, address
critical needs in terms of providing
decision makers with critical
information, and demonstrate progress
toward performance goals for national
security, facilitation of trade and travel,
and supporting immigration system
improvements. US–VISIT represents a
major achievement in creating an
integrated border screening system that
enhances our nation’s security and
efforts to reform our immigration and
border management systems. Through
US–VISIT, DHS is increasing our ability
to manage the information collected
about foreign visitors during the preentry, entry, status management, and
departure processes, which allows us to
conduct better analysis of that
information, thereby strengthening the
integrity of our immigration system.
ACTION:
Notice.
SUMMARY: The Transportation Security
Administration (TSA), as lead for DHS,
invites public comment on a new
information collection requirement
abstracted below that we will submit to
the Office of Management and Budget
(OMB) for approval in compliance with
the Paperwork Reduction Act.
DATES: Send your comments by March
6, 2007.
ADDRESSES: Comments may be mailed
or delivered to Katrina Kletzly,
Attorney-Advisor, Office of the Chief
Counsel, TSA–2, Transportation
Security Administration, 601 South
12th Street, Arlington, VA 22202–4220.
FOR FURTHER INFORMATION CONTACT:
Katrina Kletzly at the above address, or
by telephone (571) 227–1995 or
facsimile (571) 227–1381.
SUPPLEMENTARY INFORMATION:
Chase Garwood,
Chief Information Officer.
[FR Doc. 06–9987 Filed 12–29–06; 11:32 am]
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. Therefore, in preparation for
OMB review and approval of the
following information collection, TSA,
on behalf of DHS, is soliciting
comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
BILLING CODE 4410–10–P
Information Collection Requirement
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Intent To Request Approval From OMB
of One New Public Collection of
Information: Department of Homeland
Security Traveler Redress Inquiry
Program (DHS TRIP)
Transportation Security
Administration, DHS.
AGENCY:
PO 00000
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Fmt 4703
Sfmt 4703
Purpose of Data Collection
The Rice-Chertoff Initiative (RCI)
Department of Homeland Security
Traveler Redress Inquiry Program (DHS
TRIP) was developed as a voluntary
program by DHS to provide a one-stop
mechanism for individuals to request
redress who believe they have been: (1)
Denied or delayed boarding; (2) denied
or delayed entry into or departure from
the United States at a port of entry; or
(3) identified for additional (secondary)
screening at our Nation’s transportation
E:\FR\FM\05JAN1.SGM
05JAN1
Agencies
[Federal Register Volume 72, Number 3 (Friday, January 5, 2007)]
[Notices]
[Pages 574-576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0525]
Supplements and Other Changes to an Approved Application; Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to solicit comments on issues that FDA should consider when
developing revisions to its regulations regarding chemistry,
manufacturing, and controls (CMC) supplements and other changes to
approved marketing applications for human drugs. FDA is evaluating how
it could revise its regulations to allow for consideration of risk-
based approaches based on manufacturing process understanding,
including prior knowledge of similar products, and overall quality
systems to provide an enhanced risk-based approach to the CMC
regulatory process, which would reduce the number of supplements. We
will consider the input from the public meeting and comments on the
issues presented in this document as we consider whether to revise our
regulations.
DATES: The public meeting will be held on February 7, 2007, from 8:30
a.m. to 3:30 p.m. Anyone who wishes to speak at the meeting must
register and submit a summary of the presentation by January 24, 2007,
and submit an electronic copy of the presentation by January 31, 2007.
See section III of the SUPPLEMENTARY INFORMATION section of this
document for details on how to register. Submit written or electronic
comments by March 7, 2007.
ADDRESSES: The public meeting will be held at the Food and Drug
Administration, Center for Drug Evaluation and Research Conference
Room, 7519 Standish Pl., third floor, rm. A, Rockville, MD 20855. There
is parking near the building. Photo identification is required to clear
building security.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: David J. Cummings, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 3525, Rockville, MD 20993-0002, 301-796-
2400, e-mail: David.Cummings@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 28, 1999 (64 FR 34608), FDA
published a proposed rule to implement section 116 of the Food and Drug
Administration Modernization Act (FDAMA)\1\ by amending certain
regulations including Sec. 314.70 (21 CFR 314.70) regarding
supplements and other changes to approved human new drug and
abbreviated new drug marketing applications. In the Federal Register of
April 8, 2004 (69 FR 18728), FDA published the final rule (final rule)
implementing these changes. Section 314.70, as amended, requires
manufacturers to assess the effects of manufacturing changes on the
identity, strength, quality, purity, and potency of a drug as those
factors relate to the safety or effectiveness of the product, and
categorizes all changes beyond the established variations in an
approved NDA or ANDA into one of three groups--major, moderate, or
minor. Major changes require an applicant to submit and receive FDA
approval of a supplement before distribution of the product made with
the manufacturing change. Moderate changes require an applicant to
submit a supplement at least 30 days before distribution of the product
or, in some cases, submit a supplement at the time of distribution.
Minor changes require an applicant to notify FDA of the changes in an
annual report.
---------------------------------------------------------------------------
\1\ Section 116 of FDAMA (Public Law 105-115) amended the
Federal Food, Drug, and Cosmetic Act (FDCA) by adding section 506A
(21 U.S.C. 356a), which describes requirements and procedures for
making and reporting manufacturing changes to certain approved
marketing applications, including new drug applications (NDAs) and
abbreviated new drug applications (ANDAs).
---------------------------------------------------------------------------
In August 2002, FDA introduced the Pharmaceutical Current Good
Manufacturing Practices (CGMPs) for the 21st Century Initiative (CGMP
Initiative, available on the Internet at https://www.fda.gov/cder/gmp/
index.htm) to enhance and modernize the regulation of pharmaceutical
manufacturing and product quality. In September 2004 (after publication
of the final rule), FDA published a final report on ``Pharmaceutical
CGMPs for the 21st Century--A Risk-Based Approach'' (https://
www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm). As explained in
the report, FDA regulates pharmaceutical manufacturing to ensure that
the drug supply in the United States is of consistently high quality.
Because of critical public health implications of drug manufacturing,
FDA traditionally has exercised extensive control over virtually every
aspect of the manufacturing process. This regulatory approach has
contributed to pharmaceutical companies being reluctant to change their
manufacturing processes and equipment. In recent years, significant
advances in pharmaceutical manufacturing science, modern quality
management systems, and risk management approaches have taken place.
This has yielded new tools that
[[Page 575]]
can be used to help ensure manufacturing quality. The new tools enable
manufacturers to detect, analyze, correct, and prevent problems and
continuously improve their manufacturing processes. It has been the
goal of the CGMP Initiative to create a regulatory paradigm that will
encourage pharmaceutical manufacturers to use these new tools to
facilitate their decision making and implementation of manufacturing
processes to reliably produce pharmaceuticals of high quality. Under
the new paradigm, as under the current scheme, pharmaceutical
manufacturers are ultimately responsible for ensuring the quality of
their products subject to FDA regulatory oversight.
The current Sec. 314.70 categorizes postapproval CMC changes and
their associated reporting requirements without consideration of the
applicant's risk management activities or internal quality systems and
practices; therefore, Sec. 314.70 reflects a rules-based, or
prescriptive, approach to regulating postapproval manufacturing
changes. The current Sec. 314.70 may create regulatory burdens and
costs that discourage beneficial manufacturing changes and may not
support a desirable level of innovation, modernization, and flexibility
for the industry as described in the CGMP Initiative.
Consistent with the agency's risk-based approach to regulating
pharmaceutical manufacturing described in the CGMP Initiative, FDA is
considering possible revisions to Sec. 314.70. In particular, FDA is
evaluating how it could revise Sec. 314.70 to allow for more
manufacturing changes to be made without prior FDA approval using a
firm's internal change control system. FDA also is evaluating how it
could revise Sec. 314.70 to allow for consideration of risk-based
approaches based on manufacturing process understanding, including
prior knowledge of similar products, and overall quality systems to
provide an enhanced risk-based approach to the CMC regulatory process.
To accomplish this objective, FDA is considering redefining what FDA
considers to be a major manufacturing change, reducing the reporting
burden for certain changes, and creating a new reporting category of
manufacturing changes that do not require notification to FDA. FDA
anticipates that these revisions would reduce the number of
postapproval supplements that are required to be submitted. We
emphasize that under a new regulatory scheme, although the reporting
burdens for certain manufacturing changes would be reduced,
manufacturers will continue to be responsible for ensuring product
quality. FDA also is considering an approach that would retain aspects
of the current regulatory scheme to accommodate those manufacturers who
choose to continue operating within the current regulatory framework.
FDA is announcing this public meeting to solicit comments on issues
that should be considered if FDA decides to propose revisions to Sec.
314.70.
II. Questions for Discussion and Comment
FDA has prepared the following questions to help focus the comments
that will be presented at the public meeting or otherwise communicated
to the agency. Those who comment are invited to address any or all of
these questions, or raise other issues.
1. Is it valuable for the agency to move toward a more risk-based
and quality systems oriented strategy for regulating postapproval CMC
changes outside of the formal application review process? What are the
advantages and/or disadvantages?
2. Would revising Sec. 314.70 as described in this notice provide
the same level of protection to the public as the current regulatory
scheme with respect to ensuring the safety and efficacy of human drugs?
What inspectional approaches might the agency consider to evaluate
manufacturing changes while ensuring public safety?
3. Would revising Sec. 314.70 as described in this notice change
the regulatory burden on the pharmaceutical industry? If so, how would
the burden change?
4. Would reducing the prescriptiveness of Sec. 314.70 provide
manufacturers with greater regulatory flexibility? Would it encourage
manufacturers to adopt CMC-related risk management strategies? Would
there be disadvantages?
III. Registration, Agenda, and Transcript
Seating is limited and will be available on a first-come, first-
served basis. If you need special accommodations because of a
disability, please inform David J. Cummings.
Registration for Speaking Attendees: If you wish to make an oral
presentation at the meeting, you must register and submit a summary of
your presentation to David J. Cummings by January 24, 2007, via e-mail
to: David.Cummings@fda.hhs.gov. When registering, you must provide the
following information: (1) The specific topic or issue to be addressed;
(2) your name, title, company or organization, address, phone number,
and e-mail address; and (3) the approximate time requested to speak.
FDA encourages persons and groups having similar interests to
consolidate their information for presentation through a single
representative. After reviewing the requests to present, we will notify
each participant by e-mail or telephone of the amount of time allotted
and the approximate time the participant's presentation is scheduled to
begin. Presenters must send electronic copies of their presentations in
Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format
(PDF) to David J. Cummings by noon on January 31, 2007.
Agenda and Transcript: The agenda for the public meeting will be
available February 2, 2006, on FDA's Center for Drug Evaluation and
Research (CDER) Web site at: https://www.fda.gov/cder/meeting/OPS_
20070207.htm. After the meeting, the agenda, presentations, and
transcript will be placed on file in the Division of Dockets Management
(see ADDRESSES) under the docket number found in the heading of this
document and on CDER's Web site identified previously.
You may examine the meeting transcript Monday through Friday
between 9 a.m. and 4 p.m. in the Division of Dockets Management Public
Reading Room (see ADDRESSES) and on the Internet at https://www.fda.gov/
ohrms/dockets/default.htm. You may also request a copy of the
transcript from the Freedom of Information Office (HFI-35), Food and
Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the meeting at a cost of 10 cents
per page or on compact disc at a cost of $14.25 each.
IV. Comments
Regardless of attendance at the meeting, interested persons may
submit to the Division of Dockets Management (see ADDRESSES) written or
electronic comments related to the questions and the focus of this
public meeting by March 7, 2007. All relevant data and information
should be submitted with the written comments. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The received comments are available for public examination in
the Division of Dockets Management
[[Page 576]]
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-22588 Filed 1-4-07; 8:45 am]
BILLING CODE 4160-01-S