Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species, 59721-59722 [2010-24273]
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59721
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
Number of
respondents
Instrument
Employment Verification Form .............................................
Authorization for Release of Employment Information
Form .................................................................................
Authorization to Release Information Form .........................
Certification Regarding Debarment, Suspension, Disqualification and Related Matters Form ...................................
Certification of Accreditation Status for School of Nursing
Education Programs Form ...............................................
Application Checklist and Self-Certification Form ...............
Responses/
respondents
Total
responses
Hours per
response
Total burden
hours
8,000
1
8,000
.50
4,000
8,000
8,000
1
1
8,000
8,000
.10
.10
800
800
8,000
1
8,000
.10
800
500
8,000
1
1
500
8,000
.10
.50
50
4,000
........................
........................
72,500
........................
46,450
Participant Semi-Annual Employment Verification Form .....
2,300
2
4,600
.5
2,300
Total ..............................................................................
2,300
2
4,600
.5
2,300
Total ..............................................................................
The annual estimate of burden for
Participants is as follows:
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: September 22, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–24209 Filed 9–27–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0356]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Designated New
Animal Drugs for Minor Use and Minor
Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 28,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0605. 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, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 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.
Designated New Animal Drugs for
Minor Use and Minor Species; (OMB
Control Number 0910–0605)—Extension
The Minor Use and Minor Species
(MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and
Cosmetic 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,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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.
In the Federal Register of July 20,
2010 (75 FR 42094), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. In response, FDA received
E:\FR\FM\28SEN1.SGM
28SEN1
59722
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
one comment that was not responsive to
the comment request on the information
collection provision.
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
1,362
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 our Office
of Minor Use and Minor Species Animal
Drug Development by extrapolating the
current investigational new animal drug
(INAD)/new animal drug application
(NADA) 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: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24273 Filed 9–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0373]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with NOTICES
HHS.
ACTION:
Notice.
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.
SUMMARY:
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
Fax written comments on the
collection of information by October 28,
2010.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0541. 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, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 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.
DATES:
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition (OMB Control Number 0910–
0541)—Extension
As an integral part of its
decisionmaking process, FDA is
obligated under the National
Environmental Policy Act of 1969
(NEPA) to consider the environmental
impact of its actions, including allowing
notifications for food contact substances
to become effective and approving food
additive petitions, color additive
petitions and GRAS petition requests for
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
exemption from regulation as a food
additive, and actions on certain food
labeling citizen petitions, nutrient
content claims petitions, and health
claims petitions. In 1997, FDA amended
its regulations in part 25 (21 CFR part
25) to provide for categorical exclusions
for additional classes of actions that do
not individually or cumulatively have a
significant effect on the human
environment (62 FR 40570, July 29,
1997). As a result of that rulemaking,
FDA no longer routinely requires
submission of information about the
manufacturing and production of FDAregulated articles. FDA also has
eliminated the previously required
Environmental Assessment (EA) and
abbreviated EA formats from the
amended regulations. Instead, FDA has
provided guidance that contains sample
formats to help industry submit a claim
of categorical exclusion or an EA to
FDA’s Center for Food Safety and
Applied Nutrition (CFSAN). The
guidance document entitled ‘‘Preparing
a Claim of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition’’
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for FDA’s
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
The guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59721-59722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0356]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
28, 2010.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0605.
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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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.
Designated New Animal Drugs for Minor Use and Minor Species; (OMB
Control Number 0910-0605)--Extension
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and Cosmetic 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.
In the Federal Register of July 20, 2010 (75 FR 42094), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In response, FDA received
[[Page 59722]]
one comment that was not responsive to the comment request on the
information collection provision.
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
our Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug (INAD)/new
animal drug application (NADA) 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: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24273 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S
