Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 364-366 [05-28]
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364
Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
2002, or by May 16, 2005, whichever
occurs first.
Since March 17, 1999, FDA has
published six major final rules on OTC
drug monographs and several minor
amendments to existing final
monographs. The following are the six
major final rules and their date of
publication:
• Sunscreen drug products (May 21,
1999),
• Cough-cold combination drug
products (December 23, 2002),
• Antidiarrheal drug products (April
17, 2003),
• Ingrown toenail relief drug products
(May 7, 2003),
• Skin protectant drug products (June
4, 2003), and
• Antiperspirant drug products (June
9, 2003).
The effective date for the final
monograph for OTC sunscreen drug
products and for the implementation of
the new labeling format for these
products has been stayed indefinitely
(65 FR 36319, June 8, 2000, and 69 FR
53801, September 3, 2004). The effective
date for products subject to the final
rules on the other OTC drug
monographs to implement the new
labeling format will occur by the end of
2004, except for a small number of
products with annual sales less than
$25,000. Those products will have until
June 2005 to implement the new
labeling format. These dates should
enable manufacturers to coordinate the
relabeling required by the final
monographs with the relabeling
required by the OTC drug product
labeling final rule.
FDA previously estimated that 12,573
out of 39,310 SKUs were affected by the
March 17, 1999, OTC drug product
labeling final rule. Based on information
in the six final rules issued since that
time, FDA estimates that 11,250
additional SKUs have already been
affected by the OTC drug product
labeling final rule. Thus, 15,487 SKUs
remain to be affected by the OTC drug
product labeling final rule. All of these
will need to implement the new labeling
format by May 16, 2005, except for the
sunscreen drug products that are
currently deferred.
As the number of products remaining
to be affected by the OTC drug product
labeling final rule is close to the number
of products affected at the time of the
May 17, 1999, publication of that final
rule, FDA is listing the same numbers of
respondents, annual frequency per
response, and total annual responses in
this notice.
FDA believes the hours per response
and total hours may be less than the
numbers stated in the final rule for
several reasons. First, respondents have
made a number of inquiries to FDA
already since the final rule was issued
in 1999. FDA’s experience with these
inquiries is that inquiries have been less
than 2.5 or 4 hours per response,
generally averaging 0.25 to 0.5 hour per
inquiry. Second, respondents have
gained significant experience with the
final rule since 1999, reducing their
need to make additional inquiries.
Third, FDA issued a draft guidance for
industry entitled ‘‘Labeling Over-theCounter Human Drug Products;
Updating Labeling in ANDA’s’’ (66 FR
11174, February 22, 2001), which
included a number of labeling examples
to assist holders of ANDAs for OTC drug
products and manufacturers of reference
listed drugs (RLDs) for the ANDAs to
implement the new OTC drug product
labeling regulation. FDA issued a final
guidance for industry on October 18,
2002 (67 FR 64402). This guidance
should have reduced some of the hours
per response and total hours for some
NDA and ANDA holders. However, FDA
is not currently able to estimate how
much time has been reduced.
Accordingly, FDA is listing the same
hours per response and total hours in
this notice as appeared in the March 17,
1999, final rule.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
201.662
201.66
201.66(c) and (d)2
201.66(e)
Total
1There
Annual Frequency
per Response
400
400
61
25
Hours Per
Response
Total Annual
Responses
31.43
66.8
8.5
4
12,573
26,737
522
100
4
2.5
2
24
Total Hours
50,292
66,842
1,044
2,400
120,578
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–27 Filed 1–3–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
[Docket No. 2004N–0296]
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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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.
Fax written comments on the
collection of information by February 3,
2005.
DATES:
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,
ADDRESSES:
E:\FR\FM\04JAN1.SGM
04JAN1
365
Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, 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.
Good Laboratory Practice (GLP)
Regulations for Nonclinical Studies—21
CFR Part 58 (OMB Control Number
0910–0119)—Extension
Sections 409, 505, 512, and 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 348, 355, 360b, 360e) and
related statues require manufacturers of
food additives, human drugs and
biological products, animal drugs, and
medical devices to demonstrate the
safety and utility of their product by
submitting applications to FDA for
research or marketing permits. Such
applications contain, among other
important items, full reports of all
studies done to demonstrate product
safety in man and/or other animals. In
order to ensure adequate quality control
for these studies and to provide an
adequate degree of consumer protection,
the agency issued the GLP regulations.
The regulations specify minimum
voluntarily submitted to FDA by
persons desiring to market new
products. The facilities that collect this
information are typically operated by
large entities, e.g., contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
Failure to include the information in a
filing to FDA would mean that agency
scientific experts could not make a valid
determination of product safety. FDA
receives, reviews, and approves
hundreds of new product applications
each year based on information
received. The recordkeeping
requirements are necessary to document
the proper conduct of a safety study, to
assure the quality and integrity of the
resulting final report, and to provide
adequate proof of the safety of regulated
products. FDA conducts onsite audits of
records and reports, during the agency’s
inspections of testing laboratories, to
verify reliability of results submitted in
applications.
The likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
In the Federal Register of July 22,
2004 (69 FR 43853), 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:
standards for the proper conduct of
safety testing and contain sections on
facilities, personnel, equipment,
standard operating procedures (SOPs),
test and control articles, quality
assurance, protocol and conduct of a
safety study, records and reports, and
laboratory disqualification.
The GLP regulations contain
requirements for the reporting of the
results of quality assurance unit
inspections, test and control article
characterization, testing of mixtures of
test and control articles with carriers,
and an overall interpretation of
nonclinical laboratory studies. The GLP
regulations also contain recordkeeping
requirements relating to the conduct of
safety studies. Such records include: (1)
Personnel job descriptions and
summaries of training and experience;
(2) master schedules, protocols and
amendments thereto, inspection reports,
and SOPs; (3) equipment inspection,
maintenance, calibration, and testing
records; (4) documentation of feed and
water analyses and animal treatments;
(5) test article accountability records;
and (6) study documentation and raw
data.
The information collected under GLP
regulations is generally gathered by
testing facilities routinely engaged in
conducting toxicological studies and is
used as part of an application for a
research or marketing permit that is
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
58.35(b)(7)
300
60.25
18,075
1
18,075
58.185
300
60.25
18,075
27.65
499,774
Total
1There
517,849
are no capital costs or operating maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
58.29(b)
300
20
6,000
.21
1,260
58.35(b)(1) through (b)(6) and (c)
300
270.76
81,228
3.36
279,926
58.63(b) and (c)
300
60
18,000
.09
1,620
58.81(a), (b), and (c)
300
301.8
90,540
.14
12,676
58.90(c) and (g)
300
62.7
18,810
.13
2,445
58.105(a) and (b)
300
5
1,500
58.107(d)
300
1
300
58.113(a)
300
15.33
4,599
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18:02 Jan 03, 2005
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E:\FR\FM\04JAN1.SGM
11.8
17,700
4.25
6.8
04JAN1
1,275
31,273
366
Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
58.120
300
15.38
4,614
32.7
150,878
58.195
300
251.5
75,450
3.9
294,255
Total
793,308
1There
are no capital costs or operating maintenance costs associated with this collection of information.
Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–28 Filed 1–3–05; 8:45 am]
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0554]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Irradiation in the
Production, Processing, and Handling
of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information from
manufacturers of monoenergetic
neutron sources in order to comply with
an amendment to FDA’s food additive
regulations.
Submit written or electronic
comments on the collection of
information by March 7, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane., rm.
1061, Rockville, MD 20852. All
comments should be identified with the
DATES:
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18:02 Jan 03, 2005
Jkt 205001
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Irradiation in the Production,
Processing, and Handling of Food—21
CFR 179.21 (OMB Control Number
0910–0549)—Extension
In the Federal Register of December
21, 2004 (69 FR 76401), FDA announced
OMB’s approval of this collection of
information (OMB control number
0910–0549). Since this was an
emergency approval that expires on
January 31, 2005, FDA is following the
normal PRA clearance procedures by
issuing this document.
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348(a)), the use of a food
additive is deemed unsafe unless it
conforms to the terms of a regulation
prescribing its use, or to an exemption
for investigational use, or in the case of
a food additive that is a food contact
substance, there is in effect a regulation
prescribing the conditions under which
such additive may be safely used or a
notification that is effective. In response
to a petition that is submitted under
section 409 of the act to establish that
a food additive is safe, the agency may
either: (1) By order establish a
regulation (whether or not in accord
with that proposed by the petitioner)
prescribing, with respect to one or more
proposed uses of the food additive
involved, the conditions under which
such additive may be safely used
(including, but not limited to,
specifications as to the particular food
or classes of food in or on which such
additive may be used, the maximum
quantity which may be used or
permitted to remain in or on such food,
the manner in which such additive may
be added to or used in or on such food,
and any directions or other labeling or
packaging requirements for such
additive deemed necessary by him to
assure the safety of such use), and shall
notify the petitioner of such order and
the reasons for such action; or (2) by
order deny the petition and notify the
petitioner of such order and of the
reasons for such action.
In response to a petition filed by
Science Applications International
Corp., who subsequently transferred
E:\FR\FM\04JAN1.SGM
04JAN1
]]>Agencies
[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Notices]
[Pages 364-366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-28]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0296]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Regulations for Nonclinical Studies
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 3, 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,
[[Page 365]]
OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, 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.
Good Laboratory Practice (GLP) Regulations for Nonclinical
Studies--21 CFR Part 58 (OMB Control Number 0910-0119)--Extension
Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, 360e) and related statues
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the agency issued the GLP regulations. The
regulations specify minimum standards for the proper conduct of safety
testing and contain sections on facilities, personnel, equipment,
standard operating procedures (SOPs), test and control articles,
quality assurance, protocol and conduct of a safety study, records and
reports, and laboratory disqualification.
The GLP regulations contain requirements for the reporting of the
results of quality assurance unit inspections, test and control article
characterization, testing of mixtures of test and control articles with
carriers, and an overall interpretation of nonclinical laboratory
studies. The GLP regulations also contain recordkeeping requirements
relating to the conduct of safety studies. Such records include: (1)
Personnel job descriptions and summaries of training and experience;
(2) master schedules, protocols and amendments thereto, inspection
reports, and SOPs; (3) equipment inspection, maintenance, calibration,
and testing records; (4) documentation of feed and water analyses and
animal treatments; (5) test article accountability records; and (6)
study documentation and raw data.
The information collected under GLP regulations is generally
gathered by testing facilities routinely engaged in conducting
toxicological studies and is used as part of an application for a
research or marketing permit that is voluntarily submitted to FDA by
persons desiring to market new products. The facilities that collect
this information are typically operated by large entities, e.g.,
contract laboratories, sponsors of FDA-regulated products,
universities, or government agencies. Failure to include the
information in a filing to FDA would mean that agency scientific
experts could not make a valid determination of product safety. FDA
receives, reviews, and approves hundreds of new product applications
each year based on information received. The recordkeeping requirements
are necessary to document the proper conduct of a safety study, to
assure the quality and integrity of the resulting final report, and to
provide adequate proof of the safety of regulated products. FDA
conducts onsite audits of records and reports, during the agency's
inspections of testing laboratories, to verify reliability of results
submitted in applications.
The likely respondents collecting this information are contract
laboratories, sponsors of FDA-regulated products, universities, or
government agencies.
In the Federal Register of July 22, 2004 (69 FR 43853), 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 Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Record Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
58.35(b)(7) 300 60.25 18,075 1 18,075
----------------------------------------------------------------------------------------------------------------
58.185 300 60.25 18,075 27.65 499,774
----------------------------------------------------------------------------------------------------------------
Total 517,849
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Record Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
58.29(b) 300 20 6,000 .21 1,260
----------------------------------------------------------------------------------------------------------------
58.35(b)(1) 300 270.76 81,228 3.36 279,926
through (b)(6)
and (c)
----------------------------------------------------------------------------------------------------------------
58.63(b) and (c) 300 60 18,000 .09 1,620
----------------------------------------------------------------------------------------------------------------
58.81(a), (b), 300 301.8 90,540 .14 12,676
and (c)
----------------------------------------------------------------------------------------------------------------
58.90(c) and (g) 300 62.7 18,810 .13 2,445
----------------------------------------------------------------------------------------------------------------
58.105(a) and 300 5 1,500 11.8 17,700
(b)
----------------------------------------------------------------------------------------------------------------
58.107(d) 300 1 300 4.25 1,275
----------------------------------------------------------------------------------------------------------------
58.113(a) 300 15.33 4,599 6.8 31,273
----------------------------------------------------------------------------------------------------------------
[[Page 366]]
58.120 300 15.38 4,614 32.7 150,878
----------------------------------------------------------------------------------------------------------------
58.195 300 251.5 75,450 3.9 294,255
----------------------------------------------------------------------------------------------------------------
Total 793,308
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating maintenance costs associated with this collection of information.
Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-28 Filed 1-3-05; 8:45 am]
BILLING CODE 4160-01-S
