Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses, 37814-37815 [2011-16090]
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37814
Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices
included with this revised PRA
submission, were already accounted for
in the PRA package OMB approved on
December 22, 2010. Specially, the
burden associated with completing the
Prima Facie Evidence cover sheet, was
included in the burden estimate for
submitting a reimbursement request.
The burden associated with reading the
guidance paper on reporting data
inaccuracies was already included in
the burden estimate for disclosing data
inaccuracies. Form Number: CMS–
10321 (OCN: 0938–1087); Frequency:
Occasionally; Affected Public: Private
Sector: Business or other for-profits and
Not-for-profit institutions: State, Local,
or Tribal Governments; Number of
Respondents: 13,200; Number of
Responses; 71,330; Total Annual Hours:
1,927,575. (For policy questions
regarding this collection, contact Dave
Mlawsky at (410) 786–6851. For all
other issues call (410) 786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on July 28, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: June 23, 2011.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2011–16233 Filed 6–24–11; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0481]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Uses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 reporting and recordkeeping
requirements for ‘‘New Animal Drugs
for Investigational Uses.’’
DATES: Submit electronic or written
comments on the collection of
information by August 29, 2011.
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:
Juanmanuel 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: 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
SUMMARY:
PO 00000
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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,
when appropriate, and other forms of
information technology.
New Animal Drugs for Investigational
Uses—21 CFR Part 511 (OMB Control
Number 0910–0117—Extension)
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to approve new animal
drugs. Section 512(j) of the FD&C Act
(21 U.S.C. 360b(j)) authorizes FDA to
issue regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
part 511 (21 CFR part 511). If the new
animal drug is only for tests in vitro or
in laboratory research animals, the
person distributing the new animal drug
must maintain records showing the
name and post office address of the
expert or expert organization to whom
it is shipped and the date, quantity, and
batch or code mark of each shipment
and delivery for a period of 2 years after
such shipment or delivery. Before
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
Identity of the new animal drug, (2)
labeling, (3) statement of compliance of
any non-clinical laboratory studies with
good laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
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37815
Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices
information regarding the use of edible
tissues from investigational animals.
Part 511 also requires that records be
established and maintained to
document the distribution and use of
the investigational drug to assure that its
use is safe, and that the distribution is
controlled to prevent potential abuse.
The Agency uses these required records
under its Bio-Research Monitoring
Program to monitor the validity of the
studies submitted to FDA to support
new animal drug approval and to assure
that proper use of the drug is
maintained by the investigator.
Investigational new animal drugs are
used primarily by drug industry firms,
academic institutions, and the
government. Investigators may include
individuals from these entities as well
as research firms and members of the
medical professional. Respondents to
this collection of information are the
persons who use new animal drugs
investigationally.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Part
511.1(b)(4)
511.1(b)(5)
511.1(b)(6)
511.1(b)(8)
511.1(b)(9)
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
...........................................................................
...........................................................................
...........................................................................
(ii) ......................................................................
...........................................................................
206
206
206
206
206
6.01
.34
.01
.07
.07
1,238
70
2
15
15
1
8
1
2
8
1,238
560
2
30
120
Total ..............................................................................
........................
........................
........................
........................
1,950
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
21 CFR Part
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
511.1(a)(3) ...........................................................................
511.1(b)(3) ...........................................................................
511.1(b)(7)(ii) .......................................................................
511.1(b)(8)(i) ........................................................................
206
206
206
206
2.30
6.01
6.01
6.01
473
1238
1238
1238
1
1
3.5
3.5
473
1,238
4,333
4,333
Total ..............................................................................
........................
........................
........................
........................
10,377
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on
Agency communication with industry.
Based on the number of sponsors
subject to animal drug user fees, FDA
estimates that there are 206
respondents. We use this estimate
consistently throughout the table and
calculate the ‘‘No. of Responses per
Respondent’’ by dividing the total
annual responses by number of
respondents. Additional information
needed to make a final calculation of the
total burden hours (i.e., the number of
respondents, the number of
recordkeepers, the number of NCIEs
received, etc.) is derived from Agency
records.
Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16090 Filed 6–27–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
3. The opening date is June 28, 2011.
4. The expiration date is July 16,
2011.
Food and Drug Administration
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
[Docket No. FDA–2011–N–0010]
Cooperative Agreement To Support
Shellfish Safety Assistance Project
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for Food
Safety and Applied Nutrition (CFSAN),
Office of Food Safety is announcing its
intent to award a single source
cooperative agreement to support the
Interstate Shellfish Sanitation
Conference (ISSC). The purpose of this
cooperative agreement is to enhance the
FDA molluscan shellfish sanitation
program and provide the public greater
assurance of the quality and safety of
these products.
DATES: Important dates are as follows:
1. The application due date is July 15,
2011.
2. The anticipated start date is
September 1, 2011.
SUMMARY:
PO 00000
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For Programmatic and Technical
Concerns and Questions: Paul
DiStefano, Center for Food Safety and
Applied Nutrition (HFS–325), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1410.
For Administrative and Financial
Concerns and Questions: Gladys
Melendez-Bohler, Office of Acquisitions
and Grants Services (HFA–500), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1078, Rockville, MD 20857,
301–827–7175.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA–FD–11–023, 93.103.
A. Background
The CFSAN Office of Food Safety is
announcing its intent to award, a single
source cooperative agreement to the
ISSC in the amount of $325,000 for
fiscal year 2011, direct and indirect
costs combined. Subject to the
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[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37814-37815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16090]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0481]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Investigational Uses
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 reporting and
recordkeeping requirements for ``New Animal Drugs for Investigational
Uses.''
DATES: Submit electronic or written comments on the collection of
information by August 29, 2011.
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: Juanmanuel 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: 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, when
appropriate, and other forms of information technology.
New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control
Number 0910-0117--Extension)
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the
FD&C Act (21 U.S.C. 360b(j)) authorizes FDA to issue regulations
relating to the investigational use of new animal drugs. The
regulations setting forth the conditions for investigational use of new
animal drugs have been codified at part 511 (21 CFR part 511). If the
new animal drug is only for tests in vitro or in laboratory research
animals, the person distributing the new animal drug must maintain
records showing the name and post office address of the expert or
expert organization to whom it is shipped and the date, quantity, and
batch or code mark of each shipment and delivery for a period of 2
years after such shipment or delivery. Before shipping a new animal
drug for clinical investigations in animals, a sponsor must submit to
FDA a Notice of Claimed Investigational Exemption (NCIE). The NCIE must
contain, among other things, the following specific information: (1)
Identity of the new animal drug, (2) labeling, (3) statement of
compliance of any non-clinical laboratory studies with good laboratory
practices, (4) name and address of each clinical investigator, (5) the
approximate number of animals to be treated or amount of new animal
drug(s) to be shipped, and (6)
[[Page 37815]]
information regarding the use of edible tissues from investigational
animals. Part 511 also requires that records be established and
maintained to document the distribution and use of the investigational
drug to assure that its use is safe, and that the distribution is
controlled to prevent potential abuse. The Agency uses these required
records under its Bio-Research Monitoring Program to monitor the
validity of the studies submitted to FDA to support new animal drug
approval and to assure that proper use of the drug is maintained by the
investigator.
Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities as well as
research firms and members of the medical professional. Respondents to
this collection of information are the persons who use new animal drugs
investigationally.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Part Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4)..................... 206 6.01 1,238 1 1,238
511.1(b)(5)..................... 206 .34 70 8 560
511.1(b)(6)..................... 206 .01 2 1 2
511.1(b)(8) (ii)................ 206 .07 15 2 30
511.1(b)(9)..................... 206 .07 15 8 120
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,950
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Part Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
511.1(a)(3)..................... 206 2.30 473 1 473
511.1(b)(3)..................... 206 6.01 1238 1 1,238
511.1(b)(7)(ii)................. 206 6.01 1238 3.5 4,333
511.1(b)(8)(i).................. 206 6.01 1238 3.5 4,333
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,377
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on Agency communication with industry. Based on the number of
sponsors subject to animal drug user fees, FDA estimates that there are
206 respondents. We use this estimate consistently throughout the table
and calculate the ``No. of Responses per Respondent'' by dividing the
total annual responses by number of respondents. Additional information
needed to make a final calculation of the total burden hours (i.e., the
number of respondents, the number of recordkeepers, the number of NCIEs
received, etc.) is derived from Agency records.
Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16090 Filed 6-27-11; 8:45 am]
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