Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 42579-42583 [05-14698]
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Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
www.acf.hhs.gov/programs/ofs/
forms.htm) throughout the project
period. Program progress and financial
reports are due 30 days after the
reporting period. Final programmatic
and financial reports are due 90 days
after the close of the project period.
Program Progress Reports: Quarterly.
Financial Reports: Quarterly.
VII. Agency Contacts
Program Office Contact: Willa Siegel,
Administration on Children, Youth and
Families, Head Start Bureau, 330 C
Street, SW., Washington, DC 20447;
Phone: 202–205–4011; E-mail:
WSiegel@acf.hhs.gov.
Grants Management Office Contact:
Delores Dickerson, Grants Officer,
Administration on Children and
Families, 330 C Street, SW., Room 2218,
Washington, DC 20447; Phone: 202–
260–7622; E-mail:
dedickenson@acf.hhs.gov.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and Families
(ACF) will no longer publish grant
announcements in the Federal Register.
Beginning October 1, 2005, applicants will be
able to find a synopsis of all ACF grant
opportunities and apply electronically for
opportunities via: https://www.Grants.gov.
Applicants will also be able to find the
complete text of all ACF grant
announcements on the ACF Web site located
at: https://www.acf.hhs.gov/grants/.
Please reference Section IV.3 for
details about acknowledgement of
received applications.
with Intellectual Disabilities will be
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The meeting will be held at
the Aerospace Center Office Building,
Aerospace Auditorium, 6th Floor East,
901 D Street, SW., Washington, DC
20447. Individuals with disabilities who
need accommodations in order to attend
and participate in the meeting (i.e.,
interpreting services, assistive listening
devices, materials in alternative format)
should notify Sally Atwater at (202)
619–0634 no later than August 31, 2005.
Efforts will be made to meet special
requests received after that date, but
availability of special needs
accommodations to respond to these
requests cannot be guaranteed. All
meeting sites are barrier free.
Agenda: The Committee plans to
discuss matters of major concern for
people with intellectual disabilities:
Comprehensive Health Care and Long
Term Care, Dental Care, Housing and
Aging of Caregivers, Emergency
Preparedness and Direct Support
Professional Challenges.
Food and Drug Administration
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sally Atwater, Executive Director,
President’s Committee for People with
Intellectual Disabilities, Aerospace
Center Office Building, Suite 701, 901 D
Street, SW., Washington, DC 20447,
Telephone (202) 619–0634, Fax (202)
205–9519, e-mail satwater@acf.hhs.gov.
The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services on a broad
range of topics relating to programs,
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by Executive Order, is responsible for
evaluating the adequacy of current
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
SUPPLEMENTARY INFORMATION:
Dated: July 18, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–14558 Filed 7–22–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities: Notice of
Meeting
AGENCY: President’s Committee for
People With Intellectual Disabilities
(PCPID), HHS.
ACTION: Notice of meeting.
Dated: July 14, 2005.
Sally Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. 05–14617 Filed 7–22–05; 8:45 am]
BILLING CODE 4184–01–P
Thursday, September 15, 2005,
from 9 a.m. to 5 p.m. and Friday,
September 16, 2005, from 8:30 a.m. to
11:30 a.m. The full committee meeting
of the President’s Committee for People
DATES:
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[Docket No. 2005N–0100]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
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 August 24,
2005.
ADDRESSES: 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.
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.
Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals—21 CFR Parts 210
and 211 (OMB Control Number 0910–
0139)—Extension
Under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 351(a)(2)(B)), a drug
is adulterated if the methods used in, or
the facilities or controls used for, its
manufacture, processing, packing, or
holding do not conform to, or are not
operated or administered in conformity
with, current good manufacturing
practices (CGMPs) to ensure that such
drug meets the requirements of the act
as to safety, and has the identity and
strength, and meets the quality and
purity characteristics, which it purports
or is represented to possess.
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Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
FDA has the authority under section
701(a) of the act (21 U.S.C. 371(a)) to
issue regulations for the efficient
enforcement of the act regarding CGMP
procedures for manufacturing,
processing, and holding drugs and drug
products. The CGMP regulations help
ensure that drug products meet the
statutory requirements for safety and
have their purported or represented
identity, strength, quality, and purity
characteristics. The information
collection requirements in the CGMP
regulations provide FDA with the
necessary information to perform its
duty to protect public health and safety.
CGMP requirements establish
accountability in the manufacturing and
processing of drug products, provide for
meaningful FDA inspections, and
enable manufacturers to improve the
quality of drug products over time. The
CGMP recordkeeping requirements also
serve preventive and remedial purposes,
and provide crucial information if it is
necessary to recall a drug product.
The general requirements for
recordkeeping under part 211 (21 CFR
part 211) are set forth in § 211.180. Any
production, control, or distribution
record associated with a batch and
required to be maintained in
compliance with part 211 must be
retained for at least 1 year after the
expiration date of the batch and, for
certain over-the-counter (OTC) drugs, 3
years after distribution of the batch
(§ 211.180(a)). Records for all
components, drug product containers,
closures, and labeling are required to be
maintained for at least 1 year after the
expiration date and 3 years for certain
OTC products (§ 211.180(b)).
All part 211 records must be readily
available for authorized inspections
during the retention period
(§ 211.180(c)), and such records may be
retained either as original records or as
true copies (§ 211.180(d)). In addition,
21 CFR 11.2(a) provides that ‘‘[f]or
records required to be maintained but
not submitted to the agency, persons
may use electronic records in lieu of
paper records or electronic signatures in
lieu of traditional signatures, in whole
or in part, provided that the
requirements of this part are met.’’ To
the extent this electronic option is used,
the burden of maintaining paper records
should be substantially reduced, as
should any review of such records.
In order to facilitate improvements
and corrective actions, records must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
determine the need for changes in drug
product specifications or manufacturing
or control procedures (§ 211.180(e)).
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Written procedures for these evaluations
are to be established and include
provisions for a review of a
representative number of batches and,
where applicable, records associated
with the batch; provisions for a review
of complaints, recalls, returned or
salvaged drug products; and
investigations conducted under
§ 211.192 for each drug product.
The specific recordkeeping
requirements provided in table 1 of this
document are as follows:
• Section 211.34—Consultants
advising on the manufacture,
processing, packing, or holding of drug
products must have sufficient
education, training, and experience to
advise on the subject for which they are
retained. Records must be maintained
stating the name, address, and
qualifications of any consultants and the
type of service they provide.
• Section 211.67(c)—Records must be
kept of maintenance, cleaning,
sanitizing, and inspection as specified
in §§ 211.180 and 211.182.
• Section 211.68—Appropriate
controls must be exercised over
computer or related systems to assure
that changes in master production and
control records or other records are
instituted only by authorized personnel.
• Section 211.68(a)—Records must be
maintained of calibration checks,
inspections, and computer or related
system programs for automatic,
mechanical, and electronic equipment.
• Section 211.68(b)—All appropriate
controls must be exercised over all
computers or related systems and
control data systems to assure that
changes in master production and
controls records or other records are
instituted only by authorized persons.
• Section 211.72—Filters for liquid
filtration used in the manufacture,
processing, or packing of injectable drug
products intended for human use must
not release fibers into such products.
• Section 211.80(d)—Each container
or grouping of containers for
components or drug product containers
or closures must be identified with a
distinctive code for each lot in each
shipment received. This code must be
used in recording the disposition of
each lot. Each lot must be appropriately
identified as to its status.
• Section 211.100(b)—Written
production and process control
procedures must be followed in the
execution of the various production and
process control functions and must be
documented at the time of performance.
Any deviation from the written
procedures must be recorded and
justified.
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• Section 211.105(b)—Major
equipment must be identified by a
distinctive identification number or
code that must be recorded in the batch
production record to show the specific
equipment used in the manufacture of
each batch of a drug product. In cases
where only one of a particular type of
equipment exists in a manufacturing
facility, the name of the equipment may
be used in lieu of a distinctive
identification number or code.
• Section 211.122(c) —Records must
be maintained for each shipment
received of each different labeling and
packaging material indicating receipt,
examination, or testing.
• Section 211.130(e)—Inspection of
packaging and labeling facilities must be
made immediately before use to assure
that all drug products have been
removed from previous operations.
Inspection must also be made to assure
that packaging and labeling materials
not suitable for subsequent operations
have been removed. Results of
inspection must be documented in the
batch production records.
• Section 211.132(c)—Certain retail
packages of OTC drug products must
bear a statement that is prominently
placed so consumers are alerted to the
specific tamper-evident feature of the
package. The labeling statement is
required to be so placed that it will be
unaffected if the tamper-resistant feature
of the package is breached or missing.
If the tamper-evident feature chosen is
one that uses an identifying
characteristic, that characteristic is
required to be referred to in the labeling
statement.
• Section 211.132(d)—A request for an
exemption from packaging and labeling
requirements by a manufacturer or
packer is required to be submitted in the
form of a citizen petition under 21 CFR
10.30.
• Section 211.137—Requirements
regarding product expiration dating and
compliance with 21 CFR 201.17 are set
forth.
• Section 211.160(a)—The
establishment of any specifications,
standards, sampling plans, test
procedures, or other laboratory control
mechanisms, including any change in
such specifications, standards, sampling
plans, test procedures, or other
laboratory control mechanisms, must be
drafted by the appropriate
organizational unit and reviewed and
approved by the quality control unit.
These requirements must be followed
and documented at the time of
performance. Any deviation from the
written specifications, standards,
sampling plans, test procedures, or
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Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
other laboratory control mechanisms
must be recorded and justified.
• Section 211.165(e)—The accuracy,
sensitivity, specificity, and
reproducibility of test methods
employed by a firm must be established
and documented. Such validation and
documentation may be accomplished in
accordance with § 211.194(a)(2).
• Section 211.166(c)—Homeopathic
drug product requirements are set forth.
• Section 211.173—Animals used in
testing components, in-process
materials, or drug products for
compliance with established
specifications must be maintained and
controlled in a manner that assures their
suitability for their intended use. They
must be identified, and adequate
records must be maintained showing the
history of their use.
• Section 211.180(e)—Written records
required by part 211 must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
determine the need for changes in drug
product specifications or manufacturing
or control procedures. Written
procedures must be established and
followed for such evaluations and must
include provisions for a representative
number of batches, whether approved or
unapproved or rejected, and a review of
complaints, recalls, returned or salvaged
drug products, and investigations
conducted under § 211.192 for each
drug product.
• Section 211.180(f)—Procedures must
be established to assure that the
responsible officials of the firm, if they
are not personally involved in or
immediately aware of such actions, are
notified in writing of any investigations
conducted under § 211.198, § 211.204,
or § 211.208, any recalls, reports of
inspectional observations issued, or any
regulatory actions relating to good
manufacturing practices brought by
FDA.
• Section 211.182—Specifies
requirements for equipment cleaning
records and the use log.
• Section 211.184—Specifies
requirements for component, drug
product container, closure, and labeling
records.
• Section 211.186—Specifies master
production and control records
requirements.
• Section 211.188—Specifies batch
production and control records
requirements.
• Section 211.192—Specifies the
information that must be maintained on
the investigation of discrepancies found
in the review of all drug product
production and control records by the
quality control staff.
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• Section 211.194—Explains and
describes laboratory records that must
be retained.
• Section 211.196—Specifies the
information that must be included in
records on the distribution of the drug.
• Section 211.198—Specifies and
describes the handling of all complaint
files received by the applicant.
• Section 211.204—Specifies that
records be maintained of returned and
salvaged drug products and describes
the procedures involved.
• Written procedures, referred to here
as standard operating procedures
(SOPs), are required for many part 211
records. The current SOP requirements
were initially provided in a final rule
published in the Federal Register of
September 29, 1978 (43 FR 45014), and
are now an integral and familiar part of
the drug manufacturing process. The
major information collection impact of
SOPs results from their creation.
Thereafter, SOPs need to be periodically
updated. A combined estimate is
provided in table 1 of this document.
The 25 SOP provisions under part 211
in the combined maintenance estimate
include:
• Section 211.22(d)—Responsibilities
and procedures of the quality control
unit;
• Section 211.56(b)—Sanitation
procedures;
• Section 211.56(c)—Use of suitable
rodenticides, insecticides, fungicides,
fumigating agents, and cleaning and
sanitizing agents;
• Section 211.67(b)—Cleaning and
maintenance of equipment;
• Section 211.68(a)—Proper
performance of automatic, mechanical,
and electronic equipment;
• Section 211.80(a)—Receipt,
identification, storage, handling,
sampling, testing, and approval or
rejection of components and drug
product containers or closures;
• Section 211.94(d)—Standards or
specifications, methods of testing, and
methods of cleaning, sterilizing, and
processing to remove pyrogenic
properties for drug product containers
and closures;
• Section 211.100(a)—Production and
process control;
• Section 211.110(a)—Sampling and
testing of in-process materials and drug
products;
• Section 211.113(a)—Prevention of
objectionable microorganisms in drug
products not required to be sterile;
• Section 211.113(b)—Prevention of
microbiological contamination of drug
products purporting to be sterile,
including validation of any sterilization
process;
• Section 211.115(a)—System for
reprocessing batches that do not
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conform to standards or specifications,
to insure that reprocessed batches
conform with all established standards,
specifications, and characteristics;
• Section 211.122(a)—Receipt,
identification, storage, handling,
sampling, examination, and/or testing of
labeling and packaging materials;
• Section 211.125(f)—Control
procedures for the issuance of labeling;
• Section 211.130—Packaging and
label operations, prevention of mixup
and cross contamination, identification
and handling of filed drug product
containers that are set aside and held in
unlabeled condition, and identification
of the drug product with a lot or control
number that permits determination of
the history of the manufacture and
control of the batch;
• Section 211.142—Warehousing;
• Section 211.150—Distribution of
drug products;
• Section 211.160—Laboratory
controls;
• Section 211.165(c)—Testing and
release for distribution;
• Section 211.166(a)—Stability testing;
• Section 211.167—Special testing
requirements;
• Section 211.180(f)—Notification of
responsible officials of investigations,
recalls, reports of inspectional
observations, and any regulatory actions
relating to good manufacturing practice;
• Section 211.198(a)—Written and oral
complaint procedures, including quality
control unit review of any complaint
involving specifications failures, and
serious and unexpected adverse drug
experiences;
• Section 211.204—Holding, testing,
and reprocessing of returned drug
products; and
• Section 211.208—Drug product
salvaging.
Although most of the CGMP
provisions covered in this document
were created many years ago, there will
be some existing firms expanding into
new manufacturing areas and startup
firms that will need to create SOPs. As
provided in table 1 of this document,
FDA is assuming that approximately
100 firms will have to create up to 25
SOPs for a total of 2,500 records, and
the agency estimates that it will take 20
hours per recordkeeper to create 25 new
SOPs, for a total of 50,000 hours.
The burden estimates for the
recordkeeping requirements in table 1 of
this document are based on the
following factors: (1) FDA’s institutional
experience regarding creation and
review of such procedures and similar
recordkeeping requirements; and (2)
data provided to FDA to prepare an
economic analysis of the potential
economic impact of the May 3, 1996,
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proposed rule entitled ‘‘Current Good
Manufacturing Practice: Proposed
Amendment of Certain Requirements for
Finished Pharmaceuticals’’ (61 FR
20104). Annual SOP maintenance is
estimated to involve 1 hour annually
per SOP, totaling 25 hours annually per
recordkeeper.
The May 3, 1996, proposed rule
revising part 211 CGMP requirements
would require additional SOPs. Cost
estimates for those additional SOPs
were included in the proposed rule, but
are not included here. Any comments
on those estimates will be evaluated in
any final rule based on that proposal.
In the Federal Register of March 28,
2005 (70 FR 15628), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
Hours per
Recordkeeper
Total Hours
SOP Maintenance
(See list of 25
SOPs in the
SUPPLEMENTARY INFORMATION
section of this
document)
4,184
1
4,184
25
104,600
New startup SOPs
100
25
2,500
20
50,000
211.34
4,184
.25
1,046
211.67(c)
4,184
50
209,200
211.68
4,184
2
8,368
211.68(a)
4,184
10
41,840
.5
20,920
211.68(b)
4,184
5
20,920
.25
5,230
211.72
4,184
.25
1,046
211.80(d)
4,184
.25
1,046
211.100(b)
4,184
211.105(b)
4,184
211.122(c)
4,184
211.130(e)
3
.5
.25
1
1
8,368
2
105
25,104
1,046
.25
262
50
209,200
.25
52,300
4,184
50
209,200
.25
52,300
211.132(c)
1,698
20
33,960
.5
16,980
211.132(d)
1,698
340
.5
170
211.137
4,184
5
20,920
.5
10,460
211.160(a)
4,184
2
8,368
1
8,368
211.165(e)
4,184
1
4,184
1
4,184
211.166(c)
4,184
2
8,368
.5
211.173
1,077
1
1,077
.25
269
211.180(e)
4,184
.2
837
.25
209
211.180(f)
4,184
.2
837
211.182
4,184
2
8,368
.25
2,092
211.184
4,184
3
12,552
.5
6,276
211.186
4,184
10
41,840
2
83,680
211.188
4,184
25
104,600
2
209,200
211.192
4,184
2
8,368
1
8,368
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.25
52,300
1,046
.1
12,552
523
.2
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837
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Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR Section
No. of
Recordkeepers
Annual Frequency per
Recordkeeping
Hours per
Recordkeeper
Total Annual Records
Total Hours
211.194
4,184
25
104,600
.5
52,300
211.196
4,184
25
104,600
.25
26,150
211.198
4,184
5
20,920
211.204
4,184
10
41,840
1
.5
Total
1
20,920
20,920
848,625
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14698 Filed 7–21–05; 11:48 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2005–0053]
Homeland Security Advisory Council
Office of the Secretary, DHS.
Notice of Federal Advisory
Committee Meeting.
AGENCY:
ACTION:
SUMMARY: The Homeland Security
Advisory Council (HSAC) will hold a
teleconference for the purposes of
receiving a report and recommendations
from a HSAC Task Force, and holding
member deliberations. The HSAC will
receive a final report from the HSAC
Private Sector Information Sharing Task
Force, Chaired by Mayor Patrick
McCrory, Mayor of Charlotte, North
Carolina. The Task Force will report on
the topic of information sharing with
the Private Sector. Following the Task
Force report, the HSAC will hold
deliberations and discussions among
HSAC members.
DATES: This meeting will be held via
teleconference on Wednesday, August
10, 2005, and will begin at 3:05 p.m.
e.d.t.
ADDRESSES: If you desire to submit
comments, they must be submitted by
August 5, 2005. Comments must be
identified by DHS–2005–0053 and may
be submitted by one of the following
methods:
• EPA Federal Partner EDOCKET
Web Site: https://www.epa.gov/
feddocket. Follow instructions for
submitting comments on the Web site.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
VerDate jul<14>2003
14:21 Jul 22, 2005
Jkt 205001
• E-mail: HSAC@dhs.gov. Include
docket number in the subject line of the
message.
• Fax: (202) 772–9718.
• Mail: Katie Knapp, Homeland
Security Advisory Council, Department
of Homeland Security, Washington, DC
20528.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.epa.gov/feddocket. You may also
access the Federal eRulemaking Portal
at https://www.regulations.gov.
DEPARTMENT OF THE INTERIOR
For
additional information concerning the
meeting, please contact Mike Miron or
Katie Knapp of the HSAC Executive
Staff Member via email at
HSAC@dhs.gov, or via phone at (202)
692–4283.
SUMMARY: Pursuant to Section 102(2)(C)
of the National Environmental Policy
Act (NEPA) of 1969, as amended; Public
Law 102–575, Central Utah Project
Completion Act (CUPCA), as amended;
a July 2, 1999, Federal Register notice
(FR Doc. 99–16852); and a March 19,
2004, Federal Register notice (FR Doc.
04–6175); the Department of the Interior
is making available a Final EA and
FONSI for the execution of a lease of
power privilege contract and the
construction, operation, and
maintenance of a non-federal
hydroelectric generation facility on
Jordanelle Dam, Bonneville Unit,
Central Utah Project and associated
power transmission lines and facilities.
Through a competitive selection process
the joint application of the Central Utah
Water Conservancy District (District)
and Heber Light and Power (HL&P) was
selected as the potential lessee to
develop hydropower at Jordanelle Dam.
Construction and generation of power
will be accomplished by the non-federal
partnership of the District and HL&P
through a lease of power privilege with
the United States. A lease contract will
be executed among the District, HL&P,
and the Department, which defines the
development, operation, and
maintenance of a hydroelectric
generation facility at Jordanelle Dam,
consistent with the purposes and
operations of the Bonneville Unit.
FOR FURTHER INFORMATION CONTACT:
Public
Attendance: Members of the public may
register to dial in and listen to this
teleconference by contacting the
Department officials listed above no
later than 5 p.m., e.d.t., on Friday,
August 5, 2005, via e-mail at
HSAC@dhs.gov, or via phone at (202)
692–4283. Upon registration,
instructions for the dial in will be
provided. Persons with hearing
disabilities who desire to obtain a
transcript of the teleconference must
request that the Department produce
and provide a verbatim transcript based
upon special needs due to a physical
impairment at the time of registration.
Absent any such request, the
Department may not produce a verbatim
transcript of the meeting.
SUPPLEMENTARY INFORMATION:
Dated: July 19, 2005.
Kathryn Knapp,
Special Assistant, Homeland Security
Advisory Council, U.S. Department of
Homeland Security.
[FR Doc. 05–14603 Filed 7–20–05; 3:00 pm]
BILLING CODE 4410–10–P
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Central Utah Project Completion Act
Office of the Assistant
Secretary—Water and Science, Interior.
ACTION: Notice of Availability of a Final
Environmental Assessment (EA) and
Finding of No Significant Impact
(FONSI) for the execution of a lease of
power privilege contract and the
construction, operation, and
maintenance of a non-federal
hydroelectric generation facility on
Jordanelle Dam, Wasatch County, Utah,
pursuant to the lease.
AGENCY:
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 70, Number 141 (Monday, July 25, 2005)]
[Notices]
[Pages 42579-42583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14698]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0100]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Finished Pharmaceuticals
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 August
24, 2005.
ADDRESSES: 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.
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.
Current Good Manufacturing Practice Regulations for Finished
Pharmaceuticals--21 CFR Parts 210 and 211 (OMB Control Number 0910-
0139)--Extension
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the
methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to, or are
not operated or administered in conformity with, current good
manufacturing practices (CGMPs) to ensure that such drug meets the
requirements of the act as to safety, and has the identity and
strength, and meets the quality and purity characteristics, which it
purports or is represented to possess.
[[Page 42580]]
FDA has the authority under section 701(a) of the act (21 U.S.C.
371(a)) to issue regulations for the efficient enforcement of the act
regarding CGMP procedures for manufacturing, processing, and holding
drugs and drug products. The CGMP regulations help ensure that drug
products meet the statutory requirements for safety and have their
purported or represented identity, strength, quality, and purity
characteristics. The information collection requirements in the CGMP
regulations provide FDA with the necessary information to perform its
duty to protect public health and safety. CGMP requirements establish
accountability in the manufacturing and processing of drug products,
provide for meaningful FDA inspections, and enable manufacturers to
improve the quality of drug products over time. The CGMP recordkeeping
requirements also serve preventive and remedial purposes, and provide
crucial information if it is necessary to recall a drug product.
The general requirements for recordkeeping under part 211 (21 CFR
part 211) are set forth in Sec. 211.180. Any production, control, or
distribution record associated with a batch and required to be
maintained in compliance with part 211 must be retained for at least 1
year after the expiration date of the batch and, for certain over-the-
counter (OTC) drugs, 3 years after distribution of the batch (Sec.
211.180(a)). Records for all components, drug product containers,
closures, and labeling are required to be maintained for at least 1
year after the expiration date and 3 years for certain OTC products
(Sec. 211.180(b)).
All part 211 records must be readily available for authorized
inspections during the retention period (Sec. 211.180(c)), and such
records may be retained either as original records or as true copies
(Sec. 211.180(d)). In addition, 21 CFR 11.2(a) provides that ``[f]or
records required to be maintained but not submitted to the agency,
persons may use electronic records in lieu of paper records or
electronic signatures in lieu of traditional signatures, in whole or in
part, provided that the requirements of this part are met.'' To the
extent this electronic option is used, the burden of maintaining paper
records should be substantially reduced, as should any review of such
records.
In order to facilitate improvements and corrective actions, records
must be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures (Sec. 211.180(e)). Written procedures for these
evaluations are to be established and include provisions for a review
of a representative number of batches and, where applicable, records
associated with the batch; provisions for a review of complaints,
recalls, returned or salvaged drug products; and investigations
conducted under Sec. 211.192 for each drug product.
The specific recordkeeping requirements provided in table 1 of this
document are as follows:
Section 211.34--Consultants advising on the manufacture,
processing, packing, or holding of drug products must have sufficient
education, training, and experience to advise on the subject for which
they are retained. Records must be maintained stating the name,
address, and qualifications of any consultants and the type of service
they provide.
Section 211.67(c)--Records must be kept of maintenance,
cleaning, sanitizing, and inspection as specified in Sec. Sec. 211.180
and 211.182.
Section 211.68--Appropriate controls must be exercised
over computer or related systems to assure that changes in master
production and control records or other records are instituted only by
authorized personnel.
Section 211.68(a)--Records must be maintained of
calibration checks, inspections, and computer or related system
programs for automatic, mechanical, and electronic equipment.
Section 211.68(b)--All appropriate controls must be
exercised over all computers or related systems and control data
systems to assure that changes in master production and controls
records or other records are instituted only by authorized persons.
Section 211.72--Filters for liquid filtration used in the
manufacture, processing, or packing of injectable drug products
intended for human use must not release fibers into such products.
Section 211.80(d)--Each container or grouping of
containers for components or drug product containers or closures must
be identified with a distinctive code for each lot in each shipment
received. This code must be used in recording the disposition of each
lot. Each lot must be appropriately identified as to its status.
Section 211.100(b)--Written production and process control
procedures must be followed in the execution of the various production
and process control functions and must be documented at the time of
performance. Any deviation from the written procedures must be recorded
and justified.
Section 211.105(b)--Major equipment must be identified by
a distinctive identification number or code that must be recorded in
the batch production record to show the specific equipment used in the
manufacture of each batch of a drug product. In cases where only one of
a particular type of equipment exists in a manufacturing facility, the
name of the equipment may be used in lieu of a distinctive
identification number or code.
Section 211.122(c) --Records must be maintained for each
shipment received of each different labeling and packaging material
indicating receipt, examination, or testing.
Section 211.130(e)--Inspection of packaging and labeling
facilities must be made immediately before use to assure that all drug
products have been removed from previous operations. Inspection must
also be made to assure that packaging and labeling materials not
suitable for subsequent operations have been removed. Results of
inspection must be documented in the batch production records.
Section 211.132(c)--Certain retail packages of OTC drug
products must bear a statement that is prominently placed so consumers
are alerted to the specific tamper-evident feature of the package. The
labeling statement is required to be so placed that it will be
unaffected if the tamper-resistant feature of the package is breached
or missing. If the tamper-evident feature chosen is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement.
Section 211.132(d)--A request for an exemption from
packaging and labeling requirements by a manufacturer or packer is
required to be submitted in the form of a citizen petition under 21 CFR
10.30.
Section 211.137--Requirements regarding product expiration
dating and compliance with 21 CFR 201.17 are set forth.
Section 211.160(a)--The establishment of any
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, including any change in such
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, must be drafted by the appropriate
organizational unit and reviewed and approved by the quality control
unit. These requirements must be followed and documented at the time of
performance. Any deviation from the written specifications, standards,
sampling plans, test procedures, or
[[Page 42581]]
other laboratory control mechanisms must be recorded and justified.
Section 211.165(e)--The accuracy, sensitivity,
specificity, and reproducibility of test methods employed by a firm
must be established and documented. Such validation and documentation
may be accomplished in accordance with Sec. 211.194(a)(2).
Section 211.166(c)--Homeopathic drug product requirements
are set forth.
Section 211.173--Animals used in testing components, in-
process materials, or drug products for compliance with established
specifications must be maintained and controlled in a manner that
assures their suitability for their intended use. They must be
identified, and adequate records must be maintained showing the history
of their use.
Section 211.180(e)--Written records required by part 211
must be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures. Written procedures must be established and followed
for such evaluations and must include provisions for a representative
number of batches, whether approved or unapproved or rejected, and a
review of complaints, recalls, returned or salvaged drug products, and
investigations conducted under Sec. 211.192 for each drug product.
Section 211.180(f)--Procedures must be established to
assure that the responsible officials of the firm, if they are not
personally involved in or immediately aware of such actions, are
notified in writing of any investigations conducted under Sec.
211.198, Sec. 211.204, or Sec. 211.208, any recalls, reports of
inspectional observations issued, or any regulatory actions relating to
good manufacturing practices brought by FDA.
Section 211.182--Specifies requirements for equipment
cleaning records and the use log.
Section 211.184--Specifies requirements for component,
drug product container, closure, and labeling records.
Section 211.186--Specifies master production and control
records requirements.
Section 211.188--Specifies batch production and control
records requirements.
Section 211.192--Specifies the information that must be
maintained on the investigation of discrepancies found in the review of
all drug product production and control records by the quality control
staff.
Section 211.194--Explains and describes laboratory records
that must be retained.
Section 211.196--Specifies the information that must be
included in records on the distribution of the drug.
Section 211.198--Specifies and describes the handling of
all complaint files received by the applicant.
Section 211.204--Specifies that records be maintained of
returned and salvaged drug products and describes the procedures
involved.
Written procedures, referred to here as standard operating
procedures (SOPs), are required for many part 211 records. The current
SOP requirements were initially provided in a final rule published in
the Federal Register of September 29, 1978 (43 FR 45014), and are now
an integral and familiar part of the drug manufacturing process. The
major information collection impact of SOPs results from their
creation. Thereafter, SOPs need to be periodically updated. A combined
estimate is provided in table 1 of this document. The 25 SOP provisions
under part 211 in the combined maintenance estimate include:
Section 211.22(d)--Responsibilities and procedures of the
quality control unit;
Section 211.56(b)--Sanitation procedures;
Section 211.56(c)--Use of suitable rodenticides,
insecticides, fungicides, fumigating agents, and cleaning and
sanitizing agents;
Section 211.67(b)--Cleaning and maintenance of equipment;
Section 211.68(a)--Proper performance of automatic,
mechanical, and electronic equipment;
Section 211.80(a)--Receipt, identification, storage,
handling, sampling, testing, and approval or rejection of components
and drug product containers or closures;
Section 211.94(d)--Standards or specifications, methods of
testing, and methods of cleaning, sterilizing, and processing to remove
pyrogenic properties for drug product containers and closures;
Section 211.100(a)--Production and process control;
Section 211.110(a)--Sampling and testing of in-process
materials and drug products;
Section 211.113(a)--Prevention of objectionable
microorganisms in drug products not required to be sterile;
Section 211.113(b)--Prevention of microbiological
contamination of drug products purporting to be sterile, including
validation of any sterilization process;
Section 211.115(a)--System for reprocessing batches that
do not conform to standards or specifications, to insure that
reprocessed batches conform with all established standards,
specifications, and characteristics;
Section 211.122(a)--Receipt, identification, storage,
handling, sampling, examination, and/or testing of labeling and
packaging materials;
Section 211.125(f)--Control procedures for the issuance of
labeling;
Section 211.130--Packaging and label operations,
prevention of mixup and cross contamination, identification and
handling of filed drug product containers that are set aside and held
in unlabeled condition, and identification of the drug product with a
lot or control number that permits determination of the history of the
manufacture and control of the batch;
Section 211.142--Warehousing;
Section 211.150--Distribution of drug products;
Section 211.160--Laboratory controls;
Section 211.165(c)--Testing and release for distribution;
Section 211.166(a)--Stability testing;
Section 211.167--Special testing requirements;
Section 211.180(f)--Notification of responsible officials
of investigations, recalls, reports of inspectional observations, and
any regulatory actions relating to good manufacturing practice;
Section 211.198(a)--Written and oral complaint procedures,
including quality control unit review of any complaint involving
specifications failures, and serious and unexpected adverse drug
experiences;
Section 211.204--Holding, testing, and reprocessing of
returned drug products; and
Section 211.208--Drug product salvaging.
Although most of the CGMP provisions covered in this document were
created many years ago, there will be some existing firms expanding
into new manufacturing areas and startup firms that will need to create
SOPs. As provided in table 1 of this document, FDA is assuming that
approximately 100 firms will have to create up to 25 SOPs for a total
of 2,500 records, and the agency estimates that it will take 20 hours
per recordkeeper to create 25 new SOPs, for a total of 50,000 hours.
The burden estimates for the recordkeeping requirements in table 1
of this document are based on the following factors: (1) FDA's
institutional experience regarding creation and review of such
procedures and similar recordkeeping requirements; and (2) data
provided to FDA to prepare an economic analysis of the potential
economic impact of the May 3, 1996,
[[Page 42582]]
proposed rule entitled ``Current Good Manufacturing Practice: Proposed
Amendment of Certain Requirements for Finished Pharmaceuticals'' (61 FR
20104). Annual SOP maintenance is estimated to involve 1 hour annually
per SOP, totaling 25 hours annually per recordkeeper.
The May 3, 1996, proposed rule revising part 211 CGMP requirements
would require additional SOPs. Cost estimates for those additional SOPs
were included in the proposed rule, but are not included here. Any
comments on those estimates will be evaluated in any final rule based
on that proposal.
In the Federal Register of March 28, 2005 (70 FR 15628), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Hours per
21 CFR Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOP Maintenance (See list of 25 SOPs in 4,184 1 4,184 25 104,600
the SUPPLEMENTARY INFORMATION section
of this document)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New startup SOPs 100 25 2,500 20 50,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.34 4,184 .25 1,046 .5 523
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.67(c) 4,184 50 209,200 .25 52,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.68 4,184 2 8,368 1 8,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.68(a) 4,184 10 41,840 .5 20,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.68(b) 4,184 5 20,920 .25 5,230
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.72 4,184 .25 1,046 1 1,046
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.80(d) 4,184 .25 1,046 .1 105
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.100(b) 4,184 3 12,552 2 25,104
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.105(b) 4,184 .25 1,046 .25 262
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.122(c) 4,184 50 209,200 .25 52,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.130(e) 4,184 50 209,200 .25 52,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.132(c) 1,698 20 33,960 .5 16,980
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.132(d) 1,698 .2 340 .5 170
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.137 4,184 5 20,920 .5 10,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.160(a) 4,184 2 8,368 1 8,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.165(e) 4,184 1 4,184 1 4,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.166(c) 4,184 2 8,368 .5 4,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.173 1,077 1 1,077 .25 269
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.180(e) 4,184 .2 837 .25 209
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.180(f) 4,184 .2 837 1 837
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.182 4,184 2 8,368 .25 2,092
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.184 4,184 3 12,552 .5 6,276
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.186 4,184 10 41,840 2 83,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.188 4,184 25 104,600 2 209,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.192 4,184 2 8,368 1 8,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 42583]]
211.194 4,184 25 104,600 .5 52,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.196 4,184 25 104,600 .25 26,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.198 4,184 5 20,920 1 20,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
211.204 4,184 10 41,840 .5 20,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .................... ..................... .................... ..................... 848,625
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14698 Filed 7-21-05; 11:48 am]
BILLING CODE 4160-01-S
