Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 10605-10607 [2011-4219]
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10605
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices
prior to each public meeting in order to
bring pieces of equipment or medical
devices. These arrangements need to be
made with the public meeting
coordinator. It is possible that certain
requests made in advance of the public
meeting could be denied because of
unique safety, security or handling
issues related to the equipment. A
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approvals and security procedures. Any
request not submitted at least 2 weeks
in advance of the public meeting will be
denied.
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foreign visitor is assigned a host. The
host/hosting official is required to
inform the Division of Critical
Infrastructure Protection (DCIP) at least
12 business days in advance of any visit
by a foreign national visitor. Foreign
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entry.
Attendees that are Foreign Nationals
need to identify themselves as such, and
provide the following information for
security clearance to the public meeting
coordinator by the date specified in the
DATES section of this notice:
• Visitor’s full name (as it appears on
passport).
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• Country of origin and citizenship.
• Biographical data and related
information.
• Date of birth.
• Place of birth.
• Passport number.
• Passport issue date.
• Passport expiration date.
• Dates of visits.
• Company Name.
• Position/Title.
Authority: Section 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 42
U.S.C. 1395hh).
Dated: February 10, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–3812 Filed 2–24–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Refugee Assistance Program
Estimates: CMA—ORR–1.
OMB No.: 0970–0030.
Description:
The Refugee Assistance Program
Estimates: ORR–1 form is the
application for funding for the Refugee
Cash and Medical Assistance program.
Applicants for funding provide
estimates of costs of the different
components of the program—Refugee
Cash Assistance, Refugee Medical
Assistance, Health Screening, Services
to Unaccompanied Refugee Minors,
Administrative Cost of the Services to
Unaccompanied Refugee Minors
program, and Administrative Costs of
the State Refugee Coordinator.
Applicants also submit a narrative
justification for their estimates.
Applicants submit the form annually on
August 15 of the fiscal year prior to the
fiscal year for which funds are being
requested. The form may be submitted
through an On-Line Data Collection
system or hard copy format. The Office
of Refugee Resettlement uses the cost
estimate data from the ORR–1 in
determining and allocating quarterly
awards of funds and in projecting full
year costs of this program.
Respondents:
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Refugee Assistance Program Estimates: ORR–1 ...........................................
Estimated Total Annual Burden Hours: ...........................................................
srobinson on DSKHWCL6B1PROD with NOTICES
Instrument
46
........................
1
........................
2
........................
92
92
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
VerDate Mar<15>2010
16:39 Feb 24, 2011
Jkt 223001
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: February 22, 2011.
Robert Sargis,
Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
AGENCY:
Food and Drug Administration,
HHS.
[FR Doc. 2011–4278 Filed 2–24–11; 8:45 am]
ACTION:
Notice.
BILLING CODE 4184–01–P
PO 00000
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:
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\25FEN1.SGM
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10606
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices
Fax written comments on the
collection of information by March 28,
2011.
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 0910–0620. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, Juanmanuel.vilela@fda.hhs.gov.
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.
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species—
21 CFR Part 516 (OMB Control Number
0910–0620)—Extension
The Minor Use and Minor Species
Animal Health Act of 2004 (MUMS Act)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C 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
(species other than cattle, horses, swine,
chickens, turkeys, dogs, and cats), as
well as uncommon diseases in major
animal species.
The MUMS Act created three new
sections in the FD&C Act (sections 571,
572, and 573 (21 U.S.C. 360ccc, 360ccc–
1, and 360ccc–2)). The final rule (72 FR
69108, December 6, 2007) (the
December 2007 final rule) implements
section 572 of the FD&C Act that
provides for an index of legally
marketed unapproved new animal drugs
for minor species. Participation in any
part of the MUMS program is optional
so the associated paperwork only
applies to those who choose to
participate. The December 2007 final
rule specifies, among other things, the
criteria and procedures for requesting
eligibility for indexing and for
requesting addition to the index as well
as the annual reporting requirements for
index holders.
Under the new subpart C of part 516
(21 CFR part 516), § 516.119 provides
requirements for naming a permanentresident U.S. agent by foreign drug
companies, and § 516.121 provides for
informational meetings with FDA.
Section 516.123 provides requirements
for requesting informal conferences
regarding Agency administrative actions
and § 516.125 provides for
investigational use of new animal drugs
intended for indexing. Provisions for
requesting a determination of eligibility
for indexing can be found under
§ 516.129 and provisions for subsequent
requests for addition to the index can be
found under § 516.145. A description of
the written report required in § 516.145
can be found under § 516.143. Under
§ 516.141 are provisions for drug
companies to nominate a qualified
expert panel as well as the panel’s
recordkeeping requirements. Section
516.141 also calls for the submission of
a written conflict of interest statement to
FDA by each proposed panel member.
Index holders are able to modify their
index listing under § 516.161 or change
drug ownership under § 516.163.
Requirements for records and reports
are under § 516.165.
In the Federal Register of December 3,
2010 (75 FR 75481), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
Description of Respondents:
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
respondents
21 CFR section
516.119 ................................................................................
516.121 ................................................................................
516.123 ................................................................................
516.125 ................................................................................
516.129 ................................................................................
516.141 ................................................................................
516.143 ................................................................................
516.145 ................................................................................
516.161 ................................................................................
516.163 ................................................................................
516.165 ................................................................................
Total ..............................................................................
1 There
Annual
frequency per
response
2
30
3
2
30
20
20
20
1
1
10
Total annual
responses
1
2
1
3
2
1
1
1
1
1
2
2
60
3
6
60
20
20
20
1
1
20
Hours per
response
1
4
8
20
20
16
120
20
4
2
8
Total hours
2
240
24
120
1,200
320
2,400
400
4
2
160
4,872
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of recordkeepers
srobinson on DSKHWCL6B1PROD with NOTICES
21 CFR section
Annual
frequency per
recordkeeper
30
10
2
2
516.141 ................................................................................
516.165 ................................................................................
Total ..............................................................................
1 There
Total annual
records
60
20
are no capital costs or operating and maintenance costs associated with this collection of information.
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PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
E:\FR\FM\25FEN1.SGM
25FEN1
Hours per
recordkeeper
0.5
1
Total hours
30
20
50
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices
Dated: February 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4219 Filed 2–24–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0623]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary
Cosmetic Registration Program
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 March 28,
2011.
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 0910–0027. 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.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
Voluntary Cosmetic Registration
Program—21 CFR Parts 710 and 720
(OMB Control Number 0910–0027)—
Revision
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) provides FDA with
the authority to regulate cosmetic
products in the United States. Cosmetic
products that are adulterated under
section 601 of the FD&C Act (21 U.S.C.
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16:39 Feb 24, 2011
Jkt 223001
361) or misbranded under section 602 of
the FD&C Act (21 U.S.C. 362) may not
be distributed in interstate commerce.
To assist FDA in carrying out its
responsibility to regulate cosmetics, the
Agency 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.fda.gov/Cosmetics/
GuidanceComplianceRegulatory
Information/
VoluntaryCosmeticsRegistration
ProgramVCRP/OnlineRegistration/
default.htm. FDA’s online registration
system, intended to make it easier to
participate in the VCRP, was made
available industrywide 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.
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 part 720 (21 CFR part 720), FDA
requests that firms that manufacture,
pack, or distribute cosmetics file with
the Agency an ingredient statement for
each of their products. Ingredient
statements for new submissions
(§§ 720.1 through 720.4) are reported on
Form FDA 2512, ‘‘Cosmetic Product
Ingredient Statement,’’ and on Form
FDA 2512a, a continuation form.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
10607
Amendments to product formulations
(§ 720.6) also are reported on Forms
FDA 2512 and FDA 2512a. When a firm
discontinues the commercial
distribution of a cosmetic, FDA requests
that the firm file Form FDA 2514,
‘‘Notice of Discontinuance of
Commercial Distribution of Cosmetic
Product Formulation’’ (§§ 720.3 and
720.6). If any of the information
submitted on or with these forms is
confidential, the firm may submit a
request for confidentiality under
§ 720.8.
FDA’s online filing system is available
on FDA’s VCRP Web site at https://
www.fda.gov/Cosmetics/
GuidanceComplianceRegulatory
Information/
VoluntaryCosmeticsRegistration
ProgramVCRP/OnlineRegistration/
default.htm. The online filing system
contains the electronic versions of
Forms FDA 2512, 2512a, and 2514,
which are collectively found within the
electronic version of Form FDA 2512.
The Agency strongly encourages
electronic filing of Form FDA 2512
because it is faster and more convenient.
A filer will receive confirmation of
electronic filing by e-mail.
FDA places cosmetic product filing
information in a computer database and
uses the information for evaluation of
cosmetic products currently on the
market. Because filing of cosmetic
product formulations is not mandatory,
voluntary filings provide FDA with the
best information available about
cosmetic product ingredients and their
frequency of use, businesses engaged in
the manufacture and distribution of
cosmetics, and approximate rates of
product discontinuance and formula
modifications. The information assists
FDA scientists in evaluating reports of
alleged injuries and adverse reactions
from the use of cosmetics. The
information also is used in defining and
planning analytical and toxicological
studies pertaining to cosmetics.
Information from the database is
releasable to the public under FDA
compliance with the Freedom of
Information Act. FDA shares
nonconfidential information from its
files on cosmetics with consumers,
medical professionals, and industry.
In the Federal Register of December
15, 2010 (75 FR 78257), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one letter,
containing multiple comments in
response to the notice.
(Comment 1) One comment was
generally supportive of the necessity of
the information collection and its
practical utility.
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Notices]
[Pages 10605-10607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4219]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Index of Legally
Marketed Unapproved New Animal Drugs for 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.
[[Page 10606]]
DATES: Fax written comments on the collection of information by March
28, 2011.
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 0910-0620.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.
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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species--21 CFR Part 516 (OMB Control Number 0910-0620)--Extension
The Minor Use and Minor Species Animal Health Act of 2004 (MUMS
Act) amended the Federal Food, Drug, and Cosmetic Act (the FD&C 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 (species other than cattle,
horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon
diseases in major animal species.
The MUMS Act created three new sections in the FD&C Act (sections
571, 572, and 573 (21 U.S.C. 360ccc, 360ccc-1, and 360ccc-2)). The
final rule (72 FR 69108, December 6, 2007) (the December 2007 final
rule) implements section 572 of the FD&C Act that provides for an index
of legally marketed unapproved new animal drugs for minor species.
Participation in any part of the MUMS program is optional so the
associated paperwork only applies to those who choose to participate.
The December 2007 final rule specifies, among other things, the
criteria and procedures for requesting eligibility for indexing and for
requesting addition to the index as well as the annual reporting
requirements for index holders.
Under the new subpart C of part 516 (21 CFR part 516), Sec.
516.119 provides requirements for naming a permanent-resident U.S.
agent by foreign drug companies, and Sec. 516.121 provides for
informational meetings with FDA. Section 516.123 provides requirements
for requesting informal conferences regarding Agency administrative
actions and Sec. 516.125 provides for investigational use of new
animal drugs intended for indexing. Provisions for requesting a
determination of eligibility for indexing can be found under Sec.
516.129 and provisions for subsequent requests for addition to the
index can be found under Sec. 516.145. A description of the written
report required in Sec. 516.145 can be found under Sec. 516.143.
Under Sec. 516.141 are provisions for drug companies to nominate a
qualified expert panel as well as the panel's recordkeeping
requirements. Section 516.141 also calls for the submission of a
written conflict of interest statement to FDA by each proposed panel
member. Index holders are able to modify their index listing under
Sec. 516.161 or change drug ownership under Sec. 516.163.
Requirements for records and reports are under Sec. 516.165.
In the Federal Register of December 3, 2010 (75 FR 75481), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
Description of Respondents: 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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
516.119......................... 2 1 2 1 2
516.121......................... 30 2 60 4 240
516.123......................... 3 1 3 8 24
516.125......................... 2 3 6 20 120
516.129......................... 30 2 60 20 1,200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2,400
516.145......................... 20 1 20 20 400
516.161......................... 1 1 1 4 4
516.163......................... 1 1 1 2 2
516.165......................... 10 2 20 8 160
Total....................... .............. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeper records recordkeeper
----------------------------------------------------------------------------------------------------------------
516.141......................... 30 2 60 0.5 30
516.165......................... 10 2 20 1 20
Total....................... .............. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 10607]]
Dated: February 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4219 Filed 2-24-11; 8:45 am]
BILLING CODE 4160-01-P
