Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 51822-51823 [E8-20579]
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51822
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20578 Filed 9–4–08; 8:45 am]
Fax written comments on the
collection of information by October 6,
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 0910–0363. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0474] (formerly
Docket No. 2005N–0210)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Veterinary Feed
Directive
AGENCY:
FOR FURTHER INFORMATION CONTACT:
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.
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Veterinary Feed Directive—21 CFR Part
558 (OMB Control Number 0910–
0363)—Extension
With passage of the Animal Drug
Availability Act, Congress enacted
legislation establishing a new class of
restricted feed use drugs called
Veterinary Feed Directive (VFD) drugs.
The VFD class of drugs may be
distributed without involving State
pharmacy laws. Although controls on
the distribution and use of VFD drugs
are similar to controls for prescription
drugs regulated under section 503(f) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 503(f)), the implementing
VFD regulation under section 558.6 (21
CFR 558.6) is tailored to the unique
circumstances relating to the
distribution of medicated feeds. The
content of the VFD is spelled out in the
regulation. All distributors of medicated
feed containing VFD drugs must notify
FDA of their intent to distribute, and the
distribution records of all medicated
feeds containing VFD must be
maintained. The VFD regulation ensures
the protection of the public health while
enabling animal producers to obtain and
use needed drugs as efficiently and costeffectively as possible.
In the Federal Register of June 5, 2008
(73 FR 32029), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
558.6(a)(3) through (a)(5)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
15,000
25
375,000
.25
93,750
300
1
300
.25
75
20
1
20
.25
5
558.6(d)(2)
1,000
5
5,000
.25
1,250
514..1(b)(9)
1
1
1
3.00
3
558.6(d)(1)(i) through (d)(1)(iii)
558.6(d)(1)(iv)
Total
1 There
16,321
95,083
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
558.6(c)(1) through (c)(4)
112,500
10
1,125,000
.0167
18,788
558.6(e)(1) through (e)(4)
5,000
75
375,000
.0167
6,263
Total
mstockstill on PROD1PC66 with NOTICES
1 There
117,500
25,051
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
18:40 Sep 04, 2008
Jkt 214001
PO 00000
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Fmt 4703
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E:\FR\FM\05SEN1.SGM
05SEN1
51823
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20579 Filed 9–4–08; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0448]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Gammahydroxybutyric acid; Ketamine;
Dextromethorphan; Nbenzylpiperazine; 1-(3trifluoromethylphenyl)piperazine; 1-(3chlorophenyl)piperazine; 1-(4Methoxyphenyl)piperazine; 1-(3,4methylenedioxybenzyl)piperazine;
Gamma-butyrolactone; 1,4-Butanediol
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments concerning abuse potential,
actual abuse, medical usefulness,
trafficking, and impact of scheduling
changes on availability for medical use
of 10 drug substances. These comments
will be considered in preparing the
United States’ response to the World
Health Organization (WHO) regarding
the abuse liability and diversion of these
drugs. WHO will use this information to
consider whether to recommend that
certain international restrictions be
placed on these drugs. This notice
requesting comments is required by the
Controlled Substances Act (CSA).
DATES: Submit written or electronic
comments by October 6, 2008.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
James R. Hunter, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5146,
Silver Spring, MD 20993-0002, 301 796–
3156, e-mail: james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
United States is a party to the 1971
Convention on Psychotropic Substances
(the Psychotropic Convention). Article 2
of the Psychotropic Convention
provides that if a party to the
convention or WHO has information
about a substance, which in its opinion
may require international control or
change in such control, it should notify
the Secretary General of the United
Nations (the Secretary-General) and
provide the Secretary-General with
information in support of its opinion.
The CSA (21 U.S.C. 811 et seq.) (Title
II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970)
provides that when WHO notifies the
United States under Article 2 of the
Psychotropic Convention that it has
information that may justify: (1) Adding
a drug or other substances to one of the
schedules of the convention, (2)
transferring a drug or substance from
one schedule to another, or (3) deleting
it from the schedules, the Secretary of
State must transmit the notice to the
Secretary of Health and Human Services
(the Secretary of HHS). The Secretary of
HHS must then publish the notice in the
Federal Register and provide
opportunity for interested persons to
submit comments that HHS will
consider in its preparation of the
scientific and medical evaluations of the
drug or substance.
I. WHO Notification
The Secretary of HHS received the
following notices from WHO:
Ref.: C.L.16.2008
WHO Questionnaire for Collection of
Information for Review of DependenceProducing Psychoactive Substances
The World Health Organization presents its
compliments and has the pleasure of
informing Member States and Associate
Members that the Thirty-fifth Expert
Committee on Drug Dependence will meet
mstockstill on PROD1PC66 with NOTICES
Dosage Form
VerDate Aug<31>2005
18:40 Sep 04, 2008
Jkt 214001
from 20 to 23 April 2009 to review the
following substances:
1. Gamma-hydroxybutyric acid (GHB)
2. Ketamine INN
3. Dextromethorphan pINN
4. N-benzylpiperazine (BZP)
5. 1-(3-trifluoromethylphenyl)piperazine
(TFMPP)
6. 1-(3-chlorophenyl)piperazine (mCPP)
7. 1-(4-Methoxyphenyl)piperazine
(MeOPP)
8. 1-(3,4-methylenedioxybenzyl)piperazine
(MDBP)
9. Gamma-butyrolactone
10. 1,4-Butanediol
One of the essential elements of the
established review procedure is for the
Secretariat to collect relevant information
from Member States to prepare a Critical
Review Report for submission to the Expert
Committee on Drug Dependence. The World
Health Organization invites Member States to
collaborate, as in the past, in this process by
providing pertinent information mentioned
in the attached questionnaire concerning
substances listed above.
Further clarification on any of the above
items can be obtained from Quality
Assurance and Safety: Medicines,
Department of Medicines Policy and
Standards, WHO, Geneva, to which replies
should be sent not later than 20 September
2008.
The World Health Organization takes this
opportunity to renew to Member States and
Associate Members the assurance of its
highest consideration.
GENEVA, 28 May 2008
*
*
*
*
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*
*
*
*
*
1. GAMMA-HYDROXYBUTYRIC ACID
(GHB)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently authorized as
a medical or veterinary product? (Yes/No)
1.2 If ‘‘yes,’’ since when has it been on the
market?
1.3 Please indicate registered indications
alphabetically.
1.4 Please indicate known off-label medical
indications for which the substance is also
used in your country.
1.5 Please indicate dosage form(s) and
strength(s); also indicate special properties
like slow release, etc.
Strength
PO 00000
*
If statistical information requested is not
readily available, a brief descriptive answer
would be appreciated.
Please attach copies of relevant study
reports and other background information as
appropriate.
E:\FR\FM\05SEN1.SGM
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05SEN1
]]>Agencies
[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51822-51823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20579]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive
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 October
6, 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 0910-0363. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension
With passage of the Animal Drug Availability Act, Congress enacted
legislation establishing a new class of restricted feed use drugs
called Veterinary Feed Directive (VFD) drugs. The VFD class of drugs
may be distributed without involving State pharmacy laws. Although
controls on the distribution and use of VFD drugs are similar to
controls for prescription drugs regulated under section 503(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f)), the
implementing VFD regulation under section 558.6 (21 CFR 558.6) is
tailored to the unique circumstances relating to the distribution of
medicated feeds. The content of the VFD is spelled out in the
regulation. All distributors of medicated feed containing VFD drugs
must notify FDA of their intent to distribute, and the distribution
records of all medicated feeds containing VFD must be maintained. The
VFD regulation ensures the protection of the public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost-effectively as possible.
In the Federal Register of June 5, 2008 (73 FR 32029), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) 15,000 25 375,000 .25 93,750
through
(a)(5)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) 300 1 300 .25 75
through
(d)(1)(iii)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv 20 1 20 .25 5
)
----------------------------------------------------------------------------------------------------------------
558.6(d)(2) 1,000 5 5,000 .25 1,250
----------------------------------------------------------------------------------------------------------------
514..1(b)(9) 1 1 1 3.00 3
----------------------------------------------------------------------------------------------------------------
Total 16,321 .................... ................. ................. 95,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) 112,500 10 1,125,000 .0167 18,788
through
(c)(4)
----------------------------------------------------------------------------------------------------------------
558.6(e)(1) 5,000 75 375,000 .0167 6,263
through
(e)(4)
----------------------------------------------------------------------------------------------------------------
Total 117,500 .................... ................. ................. 25,051
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 51823]]
Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20579 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S
