Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 65039-65041 [E7-22587]
Download as PDF
<![CDATA[
65039
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
person review program established by
FDAMA and improve the efficiency of
510(k) review for low to moderate risk
devices.
In the Federal Register of June 21,
2007 (72 FR 34257), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section 523 of the act
Annual Frequency
per Response
Requests for accreditation
Total Annual
Responses
Hours per
Response
Total Hours
1
1
24
24
14
510(k) reviews conducted by accredited
third parties
1
24
336
40
13,440
Total
13,464
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Section 523 of the act
510(k) reviews by third-party reviewers
1 There
14
Total Annual
Records
24
Hours per
Recordkeeper
336
Total Hours
10
3,600
are no capital costs or operating and maintenance costs associated with this collection of information.
I. Reporting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Requests for Accreditation
FDA now has approximately 8 years
of experience with third-party reviews
under section 523 of the act. Currently
there are 11 active accredited third
parties. FDA does not expect to receive
more than 1 application for
accreditation per year for a total of 14
accredited third parties who will be
conducting third-party reviews.
B. 510(k) Reviews Conducted by
Accredited Third Parties
II. Recordkeeping
Third-party reviewers are required to
keep records of their review of each
submission. At the end of 3 years, the
agency expects to have 14 accredited
persons for review with each third party
reviewing on average 24 510(k)
applications per year. The agency
anticipates approximately 336 510(k)
annual submissions for third-party
review.
Dated: November 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–22586 Filed 11–16–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
Food and Drug Administration
[Docket No. 2007N–0305]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
AGENCY:
FDA has received 784 510(k)
submissions with a third-party review
since 2004. FDA estimates that over the
next 3 years, they will accredit 1 thirdparty reviewer per year for a total of 14
third parties. Each third-party reviewer
expects to review a total of 24 510(k)
submissions per year for an annual total
of 336 applications.
rwilkins on PROD1PC63 with NOTICES
Annual Frequency
per Record
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 December
19, 2007.
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 0910–0152. Also
include the FDA docket number found
in brackets in the heading of this
document.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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:
Current Good Manufacturing Practice
Regulations for Medicated Feeds—21
CFR Part 225 (OMB Control Number
0910–0152)—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
medicated feeds. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease, or growth
promotion and feed efficiency. Statutory
requirements for cGMPs have been
codified under part 225 (21 CFR part
225). Medicated feeds that are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the act.
Under part 225, a manufacturer is
required to establish, maintain, and
retain records for a medicated feed,
including records to document
procedures required during the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
E:\FR\FM\19NON1.SGM
19NON1
65040
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e. batch and stability testing),
labels, and product distribution.
This information is needed so that
FDA can: (1) Monitor drug usage and
possible misformulation of medicated
feeds, (2) investigate violative drug
residues in products from treated
animals, and (3) investigate product
defects when a drug is recalled. In
addition, FDA will use the cGMP
criteria under part 225 to determine
whether or not the systems and
procedures used by manufacturers of
medicated feeds are adequate to assure
that their feeds meet the requirements of
the act as to safety and also that they
meet their claimed identity, strength,
quality, and purity, as required by
section 501(a)(2)(B) of the act.
A license is required when the
manufacturer of a medicated feed
involves the use of a drug or drugs that
FDA has determined requires more
control because of the need for a
withdrawal period before slaughter or
because of carcinogenic concerns.
Conversely, a license is not required and
the recordkeeping requirements are less
demanding for those medicated feeds
for which FDA has determined that the
drugs used in their manufacture need
less control.
In the Federal Register of August 16,
2007 (72 FR 46089), 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.
Respondents to this collection of
information are commercial feed mills
and mixer-feeders.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS)1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeper
Total Annual
Records
225.58(c) and (d)
1,060
45
47,700
225.80(b)(2)
1,060
1,600
225.102(b)(1)
1,060
225.110(b)(1) and (b)(2)
225.115(b)(1) and (b)(2)
Hours per
Recordkeeper
Total Hours
.5
23,850
1,696,000
.12
203,520
7,800
8,268,000
.08
661,440
1,060
7,800
8,268,000
.015
124,020
1,060
5
5,300
.12
636
Total
1There
1,289,066
are no capital or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED MIXER-FEEDERS)1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
225.42(b)(5) through (b)(8)
100
260
26,000
.15
3,900
225.58(c) and (d)
100
36
3,600
.5
1,800
225.80(b)(2)
100
48
4,800
.12
225.102(b)(1) through (b)(5)
100
260
26,000
.4
Total
1There
576
10,400
16,676
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED COMMERCIAL FEED MILLS)1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
225.142
8,000
4
32,000
1
32,000
225.158
8,000
1
8,000
4
32,000
225.180
8,000
96
768,000
.12
92,160
225.202
8,000
260
2,080,000
.65
1,352,000
rwilkins on PROD1PC63 with NOTICES
Total
1There
1,508,160
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
E:\FR\FM\19NON1.SGM
19NON1
65041
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER-FEEDERS)1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
225.142
45,000
4
180,000
1
180,000
225.158
45,000
1
45,000
4
180,000
225.180
45,000
32
1,440,000
.12
172,000
225.202
45,000
260
11,700,000
.33
3,861,000
Total
4,393,000
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on agency communications with
industry. Other information needed to
finally calculate the total burden hours
(i.e., number of recordkeepers, number
of medicated feeds being manufactured,
etc.) is derived from agency records and
experience.
Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–22587 Filed 11–16–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0278]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary
Registration of Cosmetic Product
Establishments
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 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 December
19, 2007.
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
20:17 Nov 16, 2007
Jkt 214001
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0027. 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.
Voluntary Registration of Cosmetic
Product Establishments—(OMB Control
Number 0910–0027)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act) provides FDA with the
responsibility for assuring consumers
that cosmetic products in the United
States are safe and properly labeled.
Cosmetic products that are adulterated
under section 601 of the act (21 U.S.C.
361) or misbranded under section 602 of
the act (21 U.S.C. 362) may not be
distributed in interstate commerce. To
assist FDA in carrying out its
responsibility to regulate cosmetics,
FDA has developed the Voluntary
Cosmetic Registration Program (VCRP).
In 21 CFR part 710, FDA requests that
establishments that manufacture or
package cosmetic products register with
the agency on Form FDA 2511 entitled
‘‘Registration of Cosmetic Product
Establishment.’’ The term ‘‘Form FDA
2511’’ refers to both the paper and
electronic versions of the form. The
electronic version of Form FDA 2511 is
available on FDA’s VCRP Web site at
https://www.cfsan.fda.gov/~dms/cosregn.html. FDA’s online registration
system, intended to make it easier to
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
participate in the VCRP, was made
available industry-wide on December 1,
2005. The agency strongly encourages
electronic registration of Form FDA
2511 because it is faster and more
convenient. A registering facility will
receive confirmation of electronic
registration, including a registration
number, by e-mail, usually within 7
business days. The online system also
allows for amendments to past
submissions. Submission of the paper
version of Form FDA 2511 remains an
option as described in https://
www.cfsan.fda.gov/~dms/cos-reg2.html.
However, due to the high volume of
online participation, the VCRP is
allocating its limited resources
primarily to electronic registrations.
Because registration of cosmetic
product establishments is not
mandatory, voluntary registration
provides FDA with the best information
available about the locations, business
trade names, and types of activity
(manufacturing or packaging) of
cosmetic product establishments. FDA
places the registration information in a
computer database and uses the
information to generate mailing lists for
distributing regulatory information and
for inviting firms to participate in
workshops on topics in which they may
be interested. FDA also uses the
information for estimating the size of
the cosmetic industry and for
conducting onsite establishment
inspections. Registration is permanent,
although FDA requests that respondents
submit an amended Form FDA 2511 if
any of the originally submitted
information changes.
In the Federal Register of July 19,
2007 (72 FR 39626), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65039-65041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22587]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0305]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Medicated Feeds
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
December 19, 2007.
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 0910-0152. 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 Medicated Feeds--21
CFR Part 225 (OMB Control Number 0910-0152)--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
medicated feeds. Medicated feeds are administered to animals for the
prevention, cure, mitigation, or treatment of disease, or growth
promotion and feed efficiency. Statutory requirements for cGMPs have
been codified under part 225 (21 CFR part 225). Medicated feeds that
are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the act. Under
part 225, a manufacturer is required to establish, maintain, and retain
records for a medicated feed, including records to document procedures
required during the manufacturing process to assure that proper quality
control is maintained. Such records would, for example,
[[Page 65040]]
contain information concerning receipt and inventory of drug
components, batch production, laboratory assay results (i.e. batch and
stability testing), labels, and product distribution.
This information is needed so that FDA can: (1) Monitor drug usage
and possible misformulation of medicated feeds, (2) investigate
violative drug residues in products from treated animals, and (3)
investigate product defects when a drug is recalled. In addition, FDA
will use the cGMP criteria under part 225 to determine whether or not
the systems and procedures used by manufacturers of medicated feeds are
adequate to assure that their feeds meet the requirements of the act as
to safety and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the act.
A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required and the recordkeeping requirements are less demanding for
those medicated feeds for which FDA has determined that the drugs used
in their manufacture need less control.
In the Federal Register of August 16, 2007 (72 FR 46089), 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.
Respondents to this collection of information are commercial feed
mills and mixer-feeders.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeper Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.58(c) and (d) 1,060 45 47,700 .5 23,850
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.80(b)(2) 1,060 1,600 1,696,000 .12 203,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.102(b)(1) 1,060 7,800 8,268,000 .08 661,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.110(b)(1) and (b)(2) 1,060 7,800 8,268,000 .015 124,020
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.115(b)(1) and (b)(2) 1,060 5 5,300 .12 636
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,289,066
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8) 100 260 26,000 .15 3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.58(c) and (d) 100 36 3,600 .5 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.80(b)(2) 100 48 4,800 .12 576
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.102(b)(1) through (b)(5) 100 260 26,000 .4 10,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 16,676
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3.--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Commercial Feed Mills)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142 8,000 4 32,000 1 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.158 8,000 1 8,000 4 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.180 8,000 96 768,000 .12 92,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.202 8,000 260 2,080,000 .65 1,352,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,508,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 65041]]
Table 4.--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142 45,000 4 180,000 1 180,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.158 45,000 1 45,000 4 180,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.180 45,000 32 1,440,000 .12 172,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.202 45,000 260 11,700,000 .33 3,861,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 4,393,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for record preparation and
maintenance is based on agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from agency records and experience.
Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22587 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S
