Educational Workshops on Current Good Manufacturing Practices; Public Workshops, 53778-53779 [E7-18556]
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53778
Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
CFR Section
No. of
Recordkeepers
Annual Frequency
of Recordkeeping
Total Annual
Hours
Hours Per
Recordkeeper
Total Hours
820.140
8,963
1
8,963
6.34
56,825
820.150(a) and (b)
8,963
1
8,963
5.67
50,820
820.160(a) and (b)
8,963
1
8,963
0.67
6,005
820.170(a) and (b)
8,963
1
8,963
1.50
13,445
820.180(b) and (c)
8,963
1
8,963
1.50
13,445
820.181(a) through (e)
8,963
1
8,963
1.21
10,845
820.184(a) through (f)
8,963
1
8,963
1.41
12,638
820.186
8,963
1
8,963
0.40
3,585
820.198(a) through (c)
8,963
1
8,963
4.94
44,277
820.200(a) and (d)
8,963
1
8,963
2.61
23,393
820.25
8,963
1
8,963
0.67
6,005
Totals
jlentini on PROD1PC65 with NOTICES
1There
3,072,337
are no capital costs or operating and maintenance costs associated with this collection of information.
Burden (labor) hour and cost
estimates were originally developed
under FDA contract by Eastern Research
Group, Inc. (ERG), in 1996 when the
CGMP/QS regulation became final.
These figures are still accurate.
Additional factors considered in
deriving estimates included:
• Establishment Type: Query has
been made of CDRH’s registration/
listing databank and has counted 8,963
domestic firms subject to CGMPs. In
addition, hospitals which reuse or
remanufacture devices are now
considered manufacturers under new
FDA guidance. After investigations of
many hospitals and the changes in
enforcements of FDA’s requirements for
hospitals, the number of reuse or
remanufactures of SUDs have decreased
from the estimated 66 to an estimated 18
hospitals. Because the total number of
registered firms is not static, the number
of respondents will fluctuate from year
to year resulting in slight changes to the
overall burden. Currently, there are
8,963 firms subject to the CGMPs; an
increase from the last renewal of 8,254.
• Potentially Affected Establishments:
Except for manufacturers, not every type
of firm is subject to every CGMP/QS
requirement. For example, all are
subject to FDA’s quality policy
regulations (§ 820.20(a)), document
control regulations (§ 820.40), and other
requirements, whereas only
manufacturers and specification
developers are subject to FDA’s design
controls regulations (§ 820.30). The type
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of firm subject to each requirement was
identified by ERG.
FDA estimates the burden hours (and
costs) based on the last approved
renewal for this information collection.
FDA estimates that some 650 ‘‘new’’
establishments (marketing devices for
the first time) will expend some 143,052
‘‘development’’ hours on a one-time
startup basis to develop records and
procedures for the CGMP/QS regulation.
FDA estimates that annual labor hours
are apportioned as follows: 40 percent
goes to requirements dealing with
manufacturing specifications, process
controls and the DHR; 20 percent goes
to requirements dealing with
components and acceptance activities;
25 percent goes to requirements dealing
with equipment, records (the DMR and
QSR), complaint investigations,
labeling/packaging and reprocessing/
investigating product nonconformance;
and 15 percent goes to quality audit,
traceability, handling, distribution,
statistical, and other requirements.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18582 Filed 9–19–07; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Educational Workshops on Current
Good Manufacturing Practices; Public
Workshops
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshops.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
series of educational workshops on
quality pharmaceutical production
under current good manufacturing
practice (CGMP). The workshops, which
will be held in collaboration with the
Parenteral Drug Association (PDA), are
intended to educate participants on
current methods for compliance with
good manufacturing practices (GMP).
The workshops are being offered to help
ensure effective CGMP programs and to
further the common goals of FDA and
providers of quality pharmaceutical
products.
DATES: See table 1 in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: See table 1 in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Erik N. Henrikson, Center for Drug
Evaluation and Research (HF–18),
Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–9190,
erik.henrikson@fda.hhs.gov, or
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20SEN1
53779
Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Notices
Wanda Neal, Parenteral Drug
Association, 4350 East West Hwy.,
suite 200, Bethesda, MD 20814,
301–656–5900, FAX: 301–986–
0296, neal@pda.org.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Who Should Attend?
This announcement is directed
towards professionals involved in the
manufacture, control, and regulation of
pharmaceutical products who will
benefit from these workshops, including
process/production engineers,
manufacturing personnel, quality
assurance/quality control and regulatory
affairs professionals, consultants,
regulatory investigators, and CGMP
compliance officials. Other entities or
individuals may also be interested in
attending.
B. Where and When Will These
Workshops Be Held?
We have scheduled four workshops.
The locations and times are listed in
table 1 of this document.
TABLE 1.—WORKSHOP LOCATIONS AND SCHEDULES
Workshop Address
Dates and Local Times
Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814
November 1 and 2, 2007, from 9 a.m. to 5 p.m. each day
The Gresham Hotels, 23 Upper O’Connell St., Dublin 1, Ireland
December 10 and 11, 2007, from 9 a.m. to 5 p.m. each day
Peking University, Beijing, China 100871
April 21 and 22, 2008, from 9 a.m. to 5 p.m. each day
Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., Pudong, Shanghai,
China 200121
April 24 and 25, 2008, from 9 a.m. to 5 p.m. each day
C. How Can I Participate?
You can participate in person.
Anyone interested in the GMP
workshops can register through the
contact person (see FOR FURTHER
INFORMATION CONTACT).
D. Is There a Registration Fee for This
Workshop?
Yes, a registration fee is required for
this workshop. The registration fee
includes workshop reference materials
and meals. Registration fees for the
Bethesda, MD and Dublin, Ireland
workshops are listed in table 2 of this
document. The registration fee for both
China locations (Beijing and Shanghai)
is $550 with no discounts. All fees are
given in U.S. dollars.
TABLE 2.—REGISTRATION FEES FOR THE BETHESDA, MD AND DUBLIN, IRELAND WORKSHOPS
Date of Registration
PDA Member
Government Employee
or Health Authority
Nonmember
Academic
Student
Through October 1, 2007
$1,295
$1,695
$350
$3501
$150
After October 1, 2007
$1,495
$1,895
$405
$4051
$180
1 Must
be PDA member to receive this rate.
E. How Can I Get Additional
Information?
The notice of participation form,
information about the workshops, and
other related documents are available
from the contact person (see FOR
FURTHER INFORMATION CONTACT) and on
the Internet at https://www.fda.gov/cder/
workshop.htm.
FDA and industry will provide a
regulatory and practical perspective on
the current relevant critical topics.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18556 Filed 9–19–07; 8:45 am]
II. Background Information
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Why Is FDA Cosponsoring These
Workshops?
FDA is cosponsoring these 2-day
workshops to provide information and
training opportunities for industry as
well as CGMP compliance officials.
Health Resources and Services
Administration
jlentini on PROD1PC65 with NOTICES
B. What Will Be Covered?
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
The workshops will provide
information on specific topics designed
to educate and guide participants on
methodologies and implementation of
CGMP as applied to quality drug
manufacturing. Presentations by both
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
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Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Children’s Hospital
Graduate Medical Education (CHGME)
Payment
Program Annual Report: NEW
The CHGME Payment Program was
enacted by Public Law 106–129 to
provide Federal support for graduate
medical education (GME) to
freestanding children’s hospitals,
similar to Medicare GME support
received by other non-children’s
hospitals. The legislation mandates that
eligible children’s hospitals will receive
payments for both direct and indirect
medical education. Direct payments are
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[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Notices]
[Pages 53778-53779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Educational Workshops on Current Good Manufacturing Practices;
Public Workshops
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshops.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a series
of educational workshops on quality pharmaceutical production under
current good manufacturing practice (CGMP). The workshops, which will
be held in collaboration with the Parenteral Drug Association (PDA),
are intended to educate participants on current methods for compliance
with good manufacturing practices (GMP). The workshops are being
offered to help ensure effective CGMP programs and to further the
common goals of FDA and providers of quality pharmaceutical products.
DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this
document.
ADDRESSES: See table 1 in the SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Erik N. Henrikson, Center for Drug Evaluation and Research (HF-
18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-9190, erik.henrikson@fda.hhs.gov, or
[[Page 53779]]
Wanda Neal, Parenteral Drug Association, 4350 East West Hwy., suite
200, Bethesda, MD 20814, 301-656-5900, FAX: 301-986-0296, neal@pda.org.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Who Should Attend?
This announcement is directed towards professionals involved in the
manufacture, control, and regulation of pharmaceutical products who
will benefit from these workshops, including process/production
engineers, manufacturing personnel, quality assurance/quality control
and regulatory affairs professionals, consultants, regulatory
investigators, and CGMP compliance officials. Other entities or
individuals may also be interested in attending.
B. Where and When Will These Workshops Be Held?
We have scheduled four workshops. The locations and times are
listed in table 1 of this document.
Table 1.--Workshop Locations and Schedules
----------------------------------------------------------------------------------------------------------------
Workshop Address Dates and Local Times
----------------------------------------------------------------------------------------------------------------
Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, November 1 and 2, 2007, from 9 a.m. to 5 p.m. each
MD 20814 day
----------------------------------------------------------------------------------------------------------------
The Gresham Hotels, 23 Upper O'Connell St., Dublin 1, December 10 and 11, 2007, from 9 a.m. to 5 p.m.
Ireland each day
----------------------------------------------------------------------------------------------------------------
Peking University, Beijing, China 100871 April 21 and 22, 2008, from 9 a.m. to 5 p.m. each
day
----------------------------------------------------------------------------------------------------------------
Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., April 24 and 25, 2008, from 9 a.m. to 5 p.m. each
Pudong, Shanghai, China 200121 day
----------------------------------------------------------------------------------------------------------------
C. How Can I Participate?
You can participate in person. Anyone interested in the GMP
workshops can register through the contact person (see FOR FURTHER
INFORMATION CONTACT).
D. Is There a Registration Fee for This Workshop?
Yes, a registration fee is required for this workshop. The
registration fee includes workshop reference materials and meals.
Registration fees for the Bethesda, MD and Dublin, Ireland workshops
are listed in table 2 of this document. The registration fee for both
China locations (Beijing and Shanghai) is $550 with no discounts. All
fees are given in U.S. dollars.
Table 2.--Registration Fees for the Bethesda, MD and Dublin, Ireland Workshops
----------------------------------------------------------------------------------------------------------------
Government Employee or
Date of Registration PDA Member Nonmember Health Authority Academic Student
----------------------------------------------------------------------------------------------------------------
Through October 1, 2007 $1,295 $1,695 $350 $350\1\ $150
----------------------------------------------------------------------------------------------------------------
After October 1, 2007 $1,495 $1,895 $405 $405\1\ $180
----------------------------------------------------------------------------------------------------------------
\1\ Must be PDA member to receive this rate.
E. How Can I Get Additional Information?
The notice of participation form, information about the workshops,
and other related documents are available from the contact person (see
FOR FURTHER INFORMATION CONTACT) and on the Internet at https://
www.fda.gov/cder/workshop.htm.
II. Background Information
A. Why Is FDA Cosponsoring These Workshops?
FDA is cosponsoring these 2-day workshops to provide information
and training opportunities for industry as well as CGMP compliance
officials.
B. What Will Be Covered?
The workshops will provide information on specific topics designed
to educate and guide participants on methodologies and implementation
of CGMP as applied to quality drug manufacturing. Presentations by both
FDA and industry will provide a regulatory and practical perspective on
the current relevant critical topics.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18556 Filed 9-19-07; 8:45 am]
BILLING CODE 4160-01-S
