Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 67941-67942 [E7-23351]
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67941
Federal Register / Vol. 72, No. 231 / Monday, December 3, 2007 / Notices
and Treatment Act passed by Congress
in 2000.
CDC proposes to collect one year of
cost data from all 68 NBCCEDP grantees
in order to conduct the first systematic,
activity-based analysis of the costs and
cost-effectiveness of the NBCCEDP. The
information required to perform an
activity-based cost analysis includes:
Staff and consultant salaries, screening
costs, contracts and material costs,
provider payments, in-kind
contributions, administrative costs,
allocation of funds, and staff time
devoted to specific program activities.
Data will be collected electronically via
a Web-based Cost Assessment Tool
(CAT).
CDC will use information collected
through the CAT to assess the costs of
various program components, identify
factors that impact average cost, perform
cost-effectiveness analysis, and to
develop a resource allocation tool for
ensuring the most appropriate use of
limited program resources.
NBCCEDP grantees currently report
information on screening and diagnosis
volumes (the effectiveness measures for
the program) as part of the Minimum
Data Elements (MDE)/System for
Technical Assistance Reporting (STAR)
(OMB 0920–0571, exp. 1/31/2010).
Information to be collected through the
CAT will complement information
currently collected through the MDE/
STAR.
There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,496.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
NBCCEDP Grantees ...................................................................................................................
Dated: November 26, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–23336 Filed 11–30–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2007N–0306]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
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 January 2,
2008.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0154. Also
VerDate Aug<31>2005
16:17 Nov 30, 2007
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
include the FDA docket number found
in brackets in the heading of this
document.
Current Good Manufacturing Practice
Regulations for Type A Medicated
Articles—21 CFR Part 226 (OMB
Control Number 0910–0154)–Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 351), FDA has the statutory
authority to issue current good
manufacturing practice (cGMP)
regulations for drugs, including Type A
medicated articles. A Type A medicated
article is a feed product containing a
concentrated drug diluted with a feed
carrier substance. A Type A medicated
article is intended solely for use in the
manufacture of another Type A
medicated article or a Type B or Type
C medicated feed. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease or for growth
promotion and feed efficiency.
Statutory requirements for cGMPs for
Type A medicated articles have been
codified under part 226 (21 CFR part
226). Type A medicated articles which
are not manufactured in accordance
with these regulations are considered
adulterated under section 501(a)(2)(B) of
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
68
Number of
responses per
respondent
1
Average
burden per
response
(in hours)
22
the act. Under part 226, a manufacturer
is required to establish, maintain, and
retain records for Type A medicated
articles, including records to document
procedures required under the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e., batch and stability testing)
and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of Type A
medicated articles. The information
could also prove useful to FDA in
investigating product defects when a
drug is recalled. In addition, FDA will
use the cGMP criteria under part 226 to
determine whether or not the systems
used by manufacturers of Type A
medicated articles are adequate to
assure that their medicated articles meet
the requirements of the act as to safety
and also meet the article’s claimed
identity, strength, quality, and purity, as
required by section 501(a)(2)(B) of the
act.
In the Federal Register of August 16,
2007 (72 FR 46087), FDA published a
60-day notice soliciting public comment
on the proposed collection of
information provisions. In response to
that notice, no comments were received.
The respondents for Type A
medicated articles are pharmaceutical
firms that manufacture both human and
veterinary drugs, those firms that
produce only veterinary drugs, and
commercial feed mills.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03DEN1.SGM
03DEN1
67942
Federal Register / Vol. 72, No. 231 / Monday, December 3, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total
226.42
115
260
29,000
0.75
22,425
226.58
115
260
29,000
1.75
52,325
226.80
115
260
29,000
0.75
22,425
226.102
115
260
24,000
1.75
52,325
226.110
115
260
29,000
0.25
7,475
226.115
115
10
1,150
0.5
575
Total
157,550
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
record preparation and maintenance is
based on agency communications with
industry. Other information needed to
calculate the total burden hours (i.e.,
manufacturing sites, number of Type A
medicated articles being manufactured,
etc.) are derived from agency records
and experience.
Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23351 Filed 11–30–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0279]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
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 January 2,
2008.
ADDRESSES: 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: FDA Desk Officer, FAX:
VerDate Aug<31>2005
16:17 Nov 30, 2007
Jkt 214001
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0216. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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.
Color Additive Certification Requests
and Recordkeeping—OMB Control
Number 0910–0216)—Extension
FDA has regulatory oversight for color
additives used in foods, drugs,
cosmetics, and medical devices. Section
721(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
379e(a)) provides that a color additive
shall be deemed to be unsafe unless it
meets the requirements of a listing
regulation, including any requirement
for batch certification, and is used in
accordance with the regulation. FDA
lists color additives that have been
shown to be safe for their intended uses
in title 21 of the Code of Federal
Regulations (CFR). FDA requires batch
certification for all color additives listed
in 21 CFR part 74 and for all color
additives provisionally listed in 21 CFR
part 82. Color additives listed in 21 CFR
part 73 are exempted from certification.
The requirements for color additive
certification are described in part 80 (21
CFR part 80). In the certification
procedure, a representative sample of a
new batch of color additive,
accompanied by a ‘‘request for
certification’’ that provides information
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
about the batch, must be submitted to
FDA’s Office of Cosmetics and Colors.
FDA personnel perform chemical and
other analyses of the representative
sample and, providing the sample
satisfies all certification requirements,
issue a certification lot number for the
batch. FDA charges a fee for certification
based on the batch weight and requires
manufacturers to keep records of the
batch pending and after certification.
Under § 80.21, a request for
certification must include: Name of
color additive, manufacturer’s batch
number and weight in pounds, name
and address of manufacturer, storage
conditions, statement of use(s),
certification fee, and signature of person
requesting certification. Under § 80.22, a
request for certification must include a
sample of the batch of color additive
that is the subject of the request. The
sample must be labeled to show: Name
of color additive, manufacturer’s batch
number and quantity, and name and
address of person requesting
certification. Under § 80.39, the person
to whom a certificate is issued must
keep complete records showing the
disposal of all the color additive
covered by the certificate. Such records
are to be made available upon request to
any accredited representative of FDA
until at least 2 years after disposal of all
of the color additive.
The purpose for collecting this
information is to help FDA assure that
only safe color additives will be used in
foods, drugs, cosmetics, and medical
devices sold in the United States. The
required information is unique to the
batch of color additive that is the subject
of a request for certification. The
manufacturer’s batch number is used for
temporarily identifying a batch of color
additive until FDA issues a certification
lot number and for identifying a
certified batch during inspections. The
manufacturer’s batch number also aids
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 72, Number 231 (Monday, December 3, 2007)]
[Notices]
[Pages 67941-67942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0306]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles
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 January
2, 2008.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0154. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 Type A Medicated
Articles--21 CFR Part 226 (OMB Control Number 0910-0154)-Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 351), FDA has the statutory authority to issue current
good manufacturing practice (cGMP) regulations for drugs, including
Type A medicated articles. A Type A medicated article is a feed product
containing a concentrated drug diluted with a feed carrier substance. A
Type A medicated article is intended solely for use in the manufacture
of another Type A medicated article or a Type B or Type C medicated
feed. Medicated feeds are administered to animals for the prevention,
cure, mitigation, or treatment of disease or for growth promotion and
feed efficiency.
Statutory requirements for cGMPs for Type A medicated articles have
been codified under part 226 (21 CFR part 226). Type A medicated
articles which are not manufactured in accordance with these
regulations are considered adulterated under section 501(a)(2)(B) of
the act. Under part 226, a manufacturer is required to establish,
maintain, and retain records for Type A medicated articles, including
records to document procedures required under the manufacturing process
to assure that proper quality control is maintained. Such records
would, for example, contain information concerning receipt and
inventory of drug components, batch production, laboratory assay
results (i.e., batch and stability testing) and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of Type A medicated articles. The information
could also prove useful to FDA in investigating product defects when a
drug is recalled. In addition, FDA will use the cGMP criteria under
part 226 to determine whether or not the systems used by manufacturers
of Type A medicated articles are adequate to assure that their
medicated articles meet the requirements of the act as to safety and
also meet the article's claimed identity, strength, quality, and
purity, as required by section 501(a)(2)(B) of the act.
In the Federal Register of August 16, 2007 (72 FR 46087), FDA
published a 60-day notice soliciting public comment on the proposed
collection of information provisions. In response to that notice, no
comments were received.
The respondents for Type A medicated articles are pharmaceutical
firms that manufacture both human and veterinary drugs, those firms
that produce only veterinary drugs, and commercial feed mills.
FDA estimates the burden of this collection of information as
follows:
[[Page 67942]]
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42 115 260 29,000 0.75 22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.58 115 260 29,000 1.75 52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.80 115 260 29,000 0.75 22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.102 115 260 24,000 1.75 52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.110 115 260 29,000 0.25 7,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.115 115 10 1,150 0.5 575
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 157,550
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for record preparation and
maintenance is based on agency communications with industry. Other
information needed to calculate the total burden hours (i.e.,
manufacturing sites, number of Type A medicated articles being
manufactured, etc.) are derived from agency records and experience.
Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23351 Filed 11-30-07; 8:45 am]
BILLING CODE 4160-01-S
