Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species, 42094-42095 [2010-17609]
Download as PDF
<![CDATA[
42094
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
dose-response relationships for
physiologic effects and chemosensory
effects of mentholated tobacco smoke.
FDA also requested information on the
impact of menthol on the neurobiology
of tobacco dependence and information
on dose-related interactions between
menthol and nicotine, including on the
uptake and metabolism of nicotine and
on various consumer perceptions of the
product.
Activity
No. of
Respondents
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Submission of Menthol
Documents
Annual Frequency
per Response
116
The capital costs associated with this
collection pertain to the postage for
mailing documents in electronic format.
Estimating these costs is problematic
because the costs would vary depending
on the size of the document production
(e.g. one binder of documents vs.
numerous boxes of paper) and the
media type (e.g., compact disk (CD) or
digital video disk (DVD)) chosen to
submit documents. Currently, we
cannot identify how many documents
will be submitted per response.
Some sample postage costs are shown
for different types of packages:
• 10 CDs in a flat envelope weighing
30 ounces: Approximately $8 using first
class business mail,
• Five-pound parcel containing paper
documents: Approximately $12 using
business parcel post mail and delivering
to the furthest delivery zone,
• Ten-pound parcel containing paper
documents: Approximately $17 using
business parcel mail and delivering to
the furthest delivery zone, and
• Fifty-pound parcel containing paper
documents: Approximately $52 using
business parcel post mail and delivering
to the furthest delivery zone.
This estimate is based upon: (1)
Ninety three submissions (80% of 116
submissions) being submitted by
mailing an average of 10 CDs per
envelope (93 x $8 = $744) and (2)
Twenty three submissions (20% of the
116 submissions) being submitted by
mailing a package of paper documents
weighing an average of 50 pounds (23 x
$52 = $1,196.) Therefore, we estimate
the total capital costs associated with
this document submission to be $1,940.
Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17607 Filed 7–19–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Mar<15>2010
15:23 Jul 19, 2010
FDA has also requested tobacco
companies to submit consumer research
data and marketing information
pertaining to menthol cigarettes. FDA
requested consumer research data
pertaining to use, cessation, and
consumer perception of menthol
cigarettes. FDA’s request for documents
and underlying scientific information
related to marketing information
includes data and information on
Jkt 220001
Total Annual
Responses
1
Hours per
Response
116
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0356]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Designated New
Animal Drugs for Minor Use and Minor
Species
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 paperwork associated with
designation under the Minor Use and
Minor Species (MUMS) Animal Health
Act of 2004.
DATES: Submit either electronic or
written comments on the collection of
information by September 20, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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
docket number found in brackets in the
heading of this document.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
marketing strategies for each brand or
subbrand of menthol cigarettes,
including strategies targeted to
particular demographic groups,
¨
strategies aimed at tobacco-naıve
consumers, and strategies aimed at
recruitment of former tobacco users.
FDA estimates the burden of this
collection of information as follows:
Total Hours
140
Total Capital
Costs
16,240
$1,940
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20JYN1.SGM
20JYN1
42095
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
when appropriate, and other forms of
information technology.
Designated New Animal Drugs for
Minor Use and Minor Species—21 CFR
Part 516 (OMB Control No. 0910–
0605)—Extension
The Minor Use and Minor Species
(MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and
Cosmetic Act (the act) to authorize FDA
to establish new regulatory procedures
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species as well as
uncommon diseases in major animal
species. This legislation provides
incentives designed to help
pharmaceutical companies overcome
the financial burdens they face in
providing limited-demand animal
drugs. These incentives are only
available to sponsors whose drugs are
‘‘MUMS-designated’’ by FDA. Minor use
drugs are drugs for use in major species
(cattle, horses, swine, chickens, turkeys,
dogs, and cats) that are needed for
diseases that occur in only a small
number of animals either because they
occur infrequently or in limited
geographic areas. Minor species are all
animals other than the major species, for
example, zoo animals, ornamental fish,
parrots, ferrets, and guinea pigs. Some
animals of agricultural importance are
also minor species. These include
animals such as sheep, goats, catfish,
and honeybees. Participation in the
MUMS program is completely optional
for drug sponsors so the associated
paperwork only applies to those
sponsors who request and are
subsequently granted ‘‘MUMS
designation.’’ The rule specifies the
criteria and procedures for requesting
MUMS designation as well as the
annual reporting requirements for
MUMS designees.
Under part 516 (21 CFR part 516),
§ 516.20 provides requirements on the
content and format of a request for
MUMS-drug designation, § 516.26
provides requirements for amending
MUMS-drug designation, § 516.27
provides provisions for change in
sponsorship of MUMS-drug designation,
§ 516.29 provides provisions for
termination of MUMS-drug designation,
§ 516.30 provides requirements for
annual reports from sponsor(s) of
MUMS-designated drugs, and § 516.36
provides provisions for insufficient
quantities of MUMS-designated drugs.
Respondents are pharmaceutical
companies that sponsor new animal
drugs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per
Response
No. of
Respondents
21 CFR Section
Total Annual
Responses
Hours per
Response
Total Hours
516.20
15
5
75
16
1,200
516.26
3
1
3
2
6
516.27
1
1
1
1
1
516.29
2
1
2
1
2
516.30
15
5
75
2
150
516.36
1
1
1
3
3
Total
1 There
1,362
are no capital costs or operating and maintenance costs associated with this collection of information.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
The burden estimate for this reporting
requirement was derived in FDA’s
Office of Minor Use and Minor Species
Animal Drug Development by
extrapolating the current investigational
new animal drug (INAD) and new
animal drug (NAD) reporting
requirements for similar actions by this
same segment of the regulated industry
and from previous interactions with the
minor use/minor species community.
Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0374]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Petition to Request
an Exemption From 100 Percent
Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
[FR Doc. 2010–17609 Filed 7–19–10; 8:45 am]
AGENCY:
BILLING CODE 4160–01–S
HHS.
ACTION:
Food and Drug Administration,
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
VerDate Mar<15>2010
15:23 Jul 19, 2010
Jkt 220001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
reporting requirements contained in
existing FDA regulations governing
petitions to request an exemption from
100 percent identity testing of dietary
ingredients.
DATES: Submit either electronic or
written comments on the collection of
information by September 20, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42094-42095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0356]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Designated New Animal Drugs for Minor Use and Minor
Species
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 paperwork associated with
designation under the Minor Use and Minor Species (MUMS) Animal Health
Act of 2004.
DATES: Submit either electronic or written comments on the collection
of information by September 20, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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 docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: 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,
[[Page 42095]]
when appropriate, and other forms of information technology.
Designated New Animal Drugs for Minor Use and Minor Species--21 CFR
Part 516 (OMB Control No. 0910-0605)--Extension
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize
FDA to establish new regulatory procedures intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species as well as uncommon diseases in
major animal species. This legislation provides incentives designed to
help pharmaceutical companies overcome the financial burdens they face
in providing limited-demand animal drugs. These incentives are only
available to sponsors whose drugs are ``MUMS-designated'' by FDA. Minor
use drugs are drugs for use in major species (cattle, horses, swine,
chickens, turkeys, dogs, and cats) that are needed for diseases that
occur in only a small number of animals either because they occur
infrequently or in limited geographic areas. Minor species are all
animals other than the major species, for example, zoo animals,
ornamental fish, parrots, ferrets, and guinea pigs. Some animals of
agricultural importance are also minor species. These include animals
such as sheep, goats, catfish, and honeybees. Participation in the MUMS
program is completely optional for drug sponsors so the associated
paperwork only applies to those sponsors who request and are
subsequently granted ``MUMS designation.'' The rule specifies the
criteria and procedures for requesting MUMS designation as well as the
annual reporting requirements for MUMS designees.
Under part 516 (21 CFR part 516), Sec. 516.20 provides
requirements on the content and format of a request for MUMS-drug
designation, Sec. 516.26 provides requirements for amending MUMS-drug
designation, Sec. 516.27 provides provisions for change in sponsorship
of MUMS-drug designation, Sec. 516.29 provides provisions for
termination of MUMS-drug designation, Sec. 516.30 provides
requirements for annual reports from sponsor(s) of MUMS-designated
drugs, and Sec. 516.36 provides provisions for insufficient quantities
of MUMS-designated drugs. Respondents are pharmaceutical companies that
sponsor new animal drugs.
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 Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
516.20 15 5 75 16 1,200
----------------------------------------------------------------------------------------------------------------
516.26 3 1 3 2 6
----------------------------------------------------------------------------------------------------------------
516.27 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
516.29 2 1 2 1 2
----------------------------------------------------------------------------------------------------------------
516.30 15 5 75 2 150
----------------------------------------------------------------------------------------------------------------
516.36 1 1 1 3 3
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 1,362
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate for this reporting requirement was derived in
FDA's Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug (INAD) and
new animal drug (NAD) reporting requirements for similar actions by
this same segment of the regulated industry and from previous
interactions with the minor use/minor species community.
Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17609 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S
