Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice, 3712-3714 [05-1396]
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3712
Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Questionnaire
Survey
Annual Frequency
per Response
1,000
Total Annual
Responses
1
Hours per
Response
1,000
Total Hours
.167
Total
1There
167
365
are no capital costs or operating maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with consumer surveys
very similar to this proposed study.
Experimental Study on Allergen
Labeling of Food Products
As previously above, under section
903(b)(2) of the act, FDA is authorized
to conduct research relating to foods
and to conduct educational and public
information programs relating to the
safety of the Nation’s food supply. FDA
is planning to conduct an experimental
study about allergen labeling of food
products under this authority. The
Experimental Study on Allergen
Labeling of Food Products will collect
information to gauge the impact of
certain changes to the food label with
respect to information about allergenic
ingredients. This data collection is
needed to satisfy some of the
requirements of the FALCPA, including
the requirement that FDA provide data
on consumer preferences with regard to
allergen labeling in a report to Congress.
In particular, section 204.4 of the
FALCPA asks FDA to describe in the
report ‘‘* * *how consumers with food
allergies or the caretakers of consumers
would prefer that information about the
risk of cross-contact be communicated
on food labels as determined by using
appropriate survey mechanisms.’’ The
allergen labeling experiment will
supplement data collected by the
Allergen Labeling of Food Products
Consumer Preference Survey. In
addition, the experiment will address
other issues pertinent to allergen
labeling changes mandated by the
FALCPA. The experimental study data
will be collected using an Internet panel
of approximately 600,000 people who
will be screened (through self-report) for
food allergy, and food allergy caregiver
status. Participation in the allergen
experimental study is voluntary.
FDA estimates the burden of the
Experimental Study on Allergen
Labeling of Food Products collection of
information as follows:
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Questionnaire
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
600,000
1
600,000
.0028
1,680
30
1
30
.167
5
9,000
1
9,000
.167
1,503
Pre-test
Experiment
Total
1There
Total Hours
3,188
are no capital costs or operating maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with internet panel
experiments similar to the study
proposed here.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Food and Drug Administration
DATES:
Dated: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1395 Filed 1–25–05; 8:45 am]
[Docket No. 2003D–0386]
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry on Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
VerDate jul<14>2003
19:33 Jan 25, 2005
Jkt 205001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by February
25, 2005.
The Office of Management
and Budget (OMB) is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
E:\FR\FM\26JAN1.SGM
26JAN1
Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Title: Draft Guidance for Industry on
Formal Dispute Resolution: Scientific
and Technical Issues Related to
Pharmaceutical CGMP
Description: The draft guidance is
intended to provide information to
manufacturers of veterinary and human
drugs, including human biological drug
products, on how to resolve disputes of
scientific and technical issues relating
to current good manufacturing practice
(CGMP). Disputes related to scientific
and technical issues may arise during
FDA inspections of pharmaceutical
manufacturers to determine compliance
with CGMP requirements, or during
FDA’s assessment of corrective actions
undertaken as a result of such
inspections. The draft guidance
provides procedures that will encourage
open and prompt discussion of disputes
and lead to their resolution. The draft
guidance describes procedures for
raising such disputes to FDA’s Office of
Regulatory Affairs and center levels and
for requesting review by the dispute
resolution (DR) panel.
When a scientific or technical issue
arises during an FDA inspection, the
manufacturer should initially attempt to
reach agreement on the issue informally
with the investigator. Certain scientific
or technical issues may be too complex
or time-consuming to resolve during the
inspection. If resolution of a scientific or
technical issue is not accomplished
through informal mechanisms before the
issuance of the Form FDA 483, the
manufacturer can formally request DR
and can use the formal two-tiered DR
process described in the draft guidance.
Tier-one of the formal DR process
involves scientific or technical issues
raised by a manufacturer to the ORA
and center levels. If a manufacturer
disagrees with the tier-one decision,
tier-two of the formal DR process would
then be available for appealing that
decision to the DR Panel.
If a manufacturer disagrees with the
scientific or technical basis for an
observation listed by an investigator on
a Form FDA 483, the manufacturer can
SUPPLEMENTARY INFORMATION:
file a written request for formal DR with
the appropriate ORA unit as described
in the draft guidance. The request for
formal DR should be made within 10
days of the completion of an inspection,
and should include all supporting
documentation and arguments for
review, as described in the following
paragraphs. If a manufacturer disagrees
with the tier-one decision in the formal
DR process, the manufacturer can file a
written request for formal DR by the DR
Panel. The manufacturer should provide
the written request for formal DR and all
supporting documentation and
arguments, as described in the following
paragraphs, to the DR Panel within 60
days of receipt of the tier-one decision.
All requests for formal DR should be
in writing and include adequate
information to explain the nature of the
dispute and to allow FDA to act quickly
and efficiently. Each request should be
sent to the appropriate address listed in
the draft guidance and include the
following:
• Cover sheet that clearly identifies
the submission as either a request for
tier-one DR or a request for tier-two DR;
• Name and address of manufacturer
inspected (as listed on Form FDA 483);
• Date of inspection (as listed on
Form FDA 483);
• Date the Form FDA 483 issued
(from the Form FDA 483);
• FDA Establishment Identification
(FEI) Number, if available (from Form
FDA 483);
• FDA employee names and titles that
conducted inspection (from Form FDA
483);
• Office responsible for the
inspection, e.g., district office, as listed
on the Form FDA 483;
• Application number if the
inspection was a preapproval
inspection;
• Comprehensive statement of each
issue to be resolved:
Identify the observation in dispute.
Clearly present the manufacturer’s
scientific position or rationale
concerning the issue under dispute with
any supporting data.
State the steps that have been taken to
resolve the dispute, including any
informal DR that may have occurred
3713
before the issuance of the Form FDA
483.
Identify possible solutions.
State expected outcome.
• Name, title, telephone and fax
number, and e-mail address (as
available) of manufacturer contact.
Description of Respondents:
Pharmaceutical manufacturers of
veterinary and human drug products
and human biological drug products.
Burden Estimate: FDA has reviewed
the total number of informal disputes
that currently arise between
manufacturers and investigators (and
FDA district offices) when a
manufacturer disagrees with the
scientific or technical basis for an
observation listed on a Form FDA 483.
FDA estimates that approximately 12
such disputes occur annually. FDA
believes that the number of requests for
formal DR under the draft guidance
would be higher because manufacturers
have expressed reluctance to dispute
with the agency scientific or technical
issues raised in an investigation in the
absence of a formal mechanism to
resolve the dispute. In addition,
manufacturers have requested the
formal mechanisms in the draft
guidance to facilitate the review of such
disagreements. Therefore, FDA
estimates that approximately 25
manufacturers will submit
approximately 25 requests annually for
a tier-one DR. FDA also estimates that
approximately five manufacturers will
appeal approximately five of these
requests to the DR Panel (request for
tier-two DR).
Based on the time it currently takes
manufacturers to prepare responses to
FDA concerning issues raised in a Form
FDA 483, FDA estimates that it will take
manufacturers approximately 30 hours
to prepare and submit each request for
a tier-one DR and approximately 8 hours
to prepare and submit each request for
a tier-two DR.
Based on the methodology and
assumptions in the previous paragraphs,
table 1 of this document provides an
estimate of the annual reporting burden
for requests for a tier-one DR and
requests for a tier-two DR under the
draft guidance.
ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Requests for Tier-One Dispute
Resolution
VerDate jul<14>2003
19:33 Jan 25, 2005
Jkt 205001
No. of Responses
per Respondent
25
PO 00000
Total Annual
Responses
Hours per
Response
1
Frm 00044
Fmt 4703
25
Sfmt 4703
E:\FR\FM\26JAN1.SGM
Total Hours
30
26JAN1
750
3714
Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
≤Requests for Tier-Two Dispute Resolution
No. of Responses
per Respondent
5
Total Annual
Responses
1
Hours per
Response
5
8
Total
1 There
Total Hours
40
790
are no capital costs or operating and maintenance costs associated with this collection.
In the Federal Register of September
5, 2003 (68 FR 52777), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
CGMP.’’ The notice requested comments
on the information collection estimates
within 60 days. No comments were
received on the information collection
estimates. This document requests
comments on the information collection
burden that FDA estimates will result
from the draft guidance.
The draft guidance was drafted as part
of FDA’s initiative ‘‘Pharmaceutical
cGMPs for the 21st Century: A RiskBased Approach,’’ which was
announced in August 2002. The
initiative focuses on FDA’s current
CGMP program and covers the
manufacture of veterinary and human
drugs, including human biological drug
products. The agency formed the DR
Working Group comprising
representatives from ORA, the Center
for Drug Evaluation and Research, the
Center for Biologics Evaluation and
Research, and the Center for Veterinary
Medicine. The working group met
weekly on issues related to the DR
process and met with stakeholders in
December 2002 to seek their input.
The draft guidance was initiated in
response to industry’s request for a
formal DR process to resolve differences
related to scientific and technical issues
that arise between investigators and
pharmaceutical manufacturers during
FDA inspections of foreign and
domestic manufacturers. In addition to
encouraging manufacturers to use
currently available DR processes, the
draft guidance describes a formal twotiered DR process that provides a formal
mechanism for requesting review and
decision on issues that arise during
inspections:
• Tier-one of the DR process provides
a mechanism to raise scientific or
technical issues to the ORA and center
levels.
• Tier-two of the DR process provides
a mechanism to raise scientific or
technical issues to the agency’s DR
Panel for Scientific and Technical Issues
VerDate jul<14>2003
19:33 Jan 25, 2005
Jkt 205001
Related to Pharmaceutical CGMP (DR
Panel).
The draft guidance also covers the
following topics:
• The suitability of certain issues for
the formal DR process, including
examples of some issues with a
discussion of their appropriateness for
the DR process.
• Instructions on how to submit
requests for formal DR and a list of the
supporting information that should
accompany these requests.
• Public availability of decisions
reached during the DR process to
promote consistent application and
interpretation of drug quality-related
regulations.
Dated: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1396 Filed 1–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0004]
Draft Guidance for Industry on
Nonclinical Safety Evaluation of Drug
Combinations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Nonclinical Safety
Evaluation of Drug Combinations.’’ The
guidance provides recommendations on
nonclinical approaches to support the
clinical study and approval of fixeddose combination products (FDCs),
copackaged products, and adjunctive
therapies.
Submit written or electronic
comments on the draft guidance by
April 26, 2005. General comments on
agency guidance documents are
welcome at any time.
DATES:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Abby Jacobs, Center for Drug Evaluation
and Research (HFD–540), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
2020.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Nonclinical Safety Evaluation of Drug
Combinations.’’ Drug combinations
include FDCs, copackaged products,
and adjunctive therapies. An FDC is a
product in which two or more separate
drug components (active
pharmaceutical ingredients) are
combined in a single dosage form. A
copackaged product consists of two or
more separate drug products in their
final dosage form, packaged together
with appropriate labeling to support the
combination use. An adjunctive therapy
refers to the situation in which a patient
is maintained on a second drug product
that is used together with (i.e., in
adjunct to) the primary treatment,
although the relative doses are not fixed
and the drugs need not be given at the
same time. Adjunctive therapy products
may or may not be labeled for
concomitant use. The guidance
discusses all three types of drug
combinations. However, it is only
intended to describe general guiding
principles. To receive more detailed
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3712-3714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1396]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry on Formal Dispute Resolution: Scientific and Technical Issues
Related to Pharmaceutical Current Good Manufacturing Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 25, 2005.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
[[Page 3713]]
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Title: Draft Guidance for Industry on Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical CGMP
Description: The draft guidance is intended to provide information
to manufacturers of veterinary and human drugs, including human
biological drug products, on how to resolve disputes of scientific and
technical issues relating to current good manufacturing practice
(CGMP). Disputes related to scientific and technical issues may arise
during FDA inspections of pharmaceutical manufacturers to determine
compliance with CGMP requirements, or during FDA's assessment of
corrective actions undertaken as a result of such inspections. The
draft guidance provides procedures that will encourage open and prompt
discussion of disputes and lead to their resolution. The draft guidance
describes procedures for raising such disputes to FDA's Office of
Regulatory Affairs and center levels and for requesting review by the
dispute resolution (DR) panel.
When a scientific or technical issue arises during an FDA
inspection, the manufacturer should initially attempt to reach
agreement on the issue informally with the investigator. Certain
scientific or technical issues may be too complex or time-consuming to
resolve during the inspection. If resolution of a scientific or
technical issue is not accomplished through informal mechanisms before
the issuance of the Form FDA 483, the manufacturer can formally request
DR and can use the formal two-tiered DR process described in the draft
guidance.
Tier-one of the formal DR process involves scientific or technical
issues raised by a manufacturer to the ORA and center levels. If a
manufacturer disagrees with the tier-one decision, tier-two of the
formal DR process would then be available for appealing that decision
to the DR Panel.
If a manufacturer disagrees with the scientific or technical basis
for an observation listed by an investigator on a Form FDA 483, the
manufacturer can file a written request for formal DR with the
appropriate ORA unit as described in the draft guidance. The request
for formal DR should be made within 10 days of the completion of an
inspection, and should include all supporting documentation and
arguments for review, as described in the following paragraphs. If a
manufacturer disagrees with the tier-one decision in the formal DR
process, the manufacturer can file a written request for formal DR by
the DR Panel. The manufacturer should provide the written request for
formal DR and all supporting documentation and arguments, as described
in the following paragraphs, to the DR Panel within 60 days of receipt
of the tier-one decision.
All requests for formal DR should be in writing and include
adequate information to explain the nature of the dispute and to allow
FDA to act quickly and efficiently. Each request should be sent to the
appropriate address listed in the draft guidance and include the
following:
Cover sheet that clearly identifies the submission as
either a request for tier-one DR or a request for tier-two DR;
Name and address of manufacturer inspected (as listed on
Form FDA 483);
Date of inspection (as listed on Form FDA 483);
Date the Form FDA 483 issued (from the Form FDA 483);
FDA Establishment Identification (FEI) Number, if
available (from Form FDA 483);
FDA employee names and titles that conducted inspection
(from Form FDA 483);
Office responsible for the inspection, e.g., district
office, as listed on the Form FDA 483;
Application number if the inspection was a preapproval
inspection;
Comprehensive statement of each issue to be resolved:
Identify the observation in dispute.
Clearly present the manufacturer's scientific position or rationale
concerning the issue under dispute with any supporting data.
State the steps that have been taken to resolve the dispute,
including any informal DR that may have occurred before the issuance of
the Form FDA 483.
Identify possible solutions.
State expected outcome.
Name, title, telephone and fax number, and e-mail address
(as available) of manufacturer contact.
Description of Respondents: Pharmaceutical manufacturers of
veterinary and human drug products and human biological drug products.
Burden Estimate: FDA has reviewed the total number of informal
disputes that currently arise between manufacturers and investigators
(and FDA district offices) when a manufacturer disagrees with the
scientific or technical basis for an observation listed on a Form FDA
483. FDA estimates that approximately 12 such disputes occur annually.
FDA believes that the number of requests for formal DR under the draft
guidance would be higher because manufacturers have expressed
reluctance to dispute with the agency scientific or technical issues
raised in an investigation in the absence of a formal mechanism to
resolve the dispute. In addition, manufacturers have requested the
formal mechanisms in the draft guidance to facilitate the review of
such disagreements. Therefore, FDA estimates that approximately 25
manufacturers will submit approximately 25 requests annually for a
tier-one DR. FDA also estimates that approximately five manufacturers
will appeal approximately five of these requests to the DR Panel
(request for tier-two DR).
Based on the time it currently takes manufacturers to prepare
responses to FDA concerning issues raised in a Form FDA 483, FDA
estimates that it will take manufacturers approximately 30 hours to
prepare and submit each request for a tier-one DR and approximately 8
hours to prepare and submit each request for a tier-two DR.
Based on the methodology and assumptions in the previous
paragraphs, table 1 of this document provides an estimate of the annual
reporting burden for requests for a tier-one DR and requests for a
tier-two DR under the draft guidance.
Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of No. of Responses per Total Annual Hours per
Respondents Respondent Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Requests 25 1 25 30 750
for Tier-
One
Dispute
Resolution
----------------------------------------------------------------------------------------------------------------
[[Page 3714]]
>Requests 5 1 5 8 40
for Tier-
Two
Dispute
Resolution
----------------------------------------------------------------------------------------------------------------
Total 790
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
In the Federal Register of September 5, 2003 (68 FR 52777), FDA
announced the availability of a draft guidance for industry entitled
``Formal Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical CGMP.'' The notice requested comments on the information
collection estimates within 60 days. No comments were received on the
information collection estimates. This document requests comments on
the information collection burden that FDA estimates will result from
the draft guidance.
The draft guidance was drafted as part of FDA's initiative
``Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach,''
which was announced in August 2002. The initiative focuses on FDA's
current CGMP program and covers the manufacture of veterinary and human
drugs, including human biological drug products. The agency formed the
DR Working Group comprising representatives from ORA, the Center for
Drug Evaluation and Research, the Center for Biologics Evaluation and
Research, and the Center for Veterinary Medicine. The working group met
weekly on issues related to the DR process and met with stakeholders in
December 2002 to seek their input.
The draft guidance was initiated in response to industry's request
for a formal DR process to resolve differences related to scientific
and technical issues that arise between investigators and
pharmaceutical manufacturers during FDA inspections of foreign and
domestic manufacturers. In addition to encouraging manufacturers to use
currently available DR processes, the draft guidance describes a formal
two-tiered DR process that provides a formal mechanism for requesting
review and decision on issues that arise during inspections:
Tier-one of the DR process provides a mechanism to raise
scientific or technical issues to the ORA and center levels.
Tier-two of the DR process provides a mechanism to raise
scientific or technical issues to the agency's DR Panel for Scientific
and Technical Issues Related to Pharmaceutical CGMP (DR Panel).
The draft guidance also covers the following topics:
The suitability of certain issues for the formal DR
process, including examples of some issues with a discussion of their
appropriateness for the DR process.
Instructions on how to submit requests for formal DR and a
list of the supporting information that should accompany these
requests.
Public availability of decisions reached during the DR
process to promote consistent application and interpretation of drug
quality-related regulations.
Dated: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1396 Filed 1-25-05; 8:45 am]
BILLING CODE 4160-01-S
