Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission Gateway, 28851-28852 [2013-11632]
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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
burden per response for the needs
assessment survey is 20 minutes.
The results of the needs assessment
will inform the development of the
Work@Health training curriculum and
delivery methods. CDC anticipates that
training will be offered in four models
(formats): (1) A ‘‘Hands-on’’ instructorled workshop model (T1), (2) a selfpaced ‘‘Online’’ model (T2), (3) a
combination or ‘‘Blended’’ model (T3),
and (4) a ‘‘Train-the-Trainer’’ model
(T4) designed to prepare qualified
individuals to train employers through
the Hands-on, Online, or Blended
models.
Employers who are interested in
participating in Work@Health training
will be asked to complete a Pilot
Employer Application Form. To be
eligible for the T1–T3 pilot trainings,
employers must have a minimum of 30
employees, a valid business license, and
completion of the pilot training, each
participant will be asked to complete a
15–20 minute evaluation survey. The
customized survey questions will allow
CDC to assess respondent satisfaction
with the procedures, methods, content
and strategies employed in each
workplace health training model. The
information collected in the pilot
training evaluation surveys will inform
future modifications and improvements
to the training based on employers’
experiences, needs, and
recommendations. Only the evaluation
survey for the Online model pilot will
be the administered electronically, all
others will be paper/pencil surveys.
Participation is voluntary and there
are no costs to participants other than
their time. A separate information
collection request will be submitted to
obtain OMB approval for Phase 2
information collection.
have been in business for at least one
year. In addition, they must offer health
insurance to their employees and have
minimal workplace health program
knowledge and experience. To be
eligible for the T4 training model,
applicants may be employers, health
departments, business coalitions, trade
associations, or other organizations.
Participants in the T4 training must
have previous knowledge, training and
experience with workplace health
programs, and an interest in becoming
facilitators for the Work@Health
program.
CDC anticipates the receipt of
approximately 400 applications. CDC
will use the application information to
select 72 respondents for Phase 1 pilot
training and evaluation activities (18
respondents per model). Three-fourths
of these individuals will represent small
and mid-size employers. Upon
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hr)
Number of
responses per
respondent
Total burden
(in hr)
Type of respondents
Form name
Employers .........................................
Employers Participating in the
Work@Health Pilot Training Program.
Training Needs Assessment Survey
Pilot Employer Application Form ......
200
400
1
1
20/60
5/60
67
33
Hands-On Pilot Training Evaluation
Survey.
Hands-On Pilot Training Evaluation
Survey.
Blended Model Pilot Training Evaluation Survey.
Pilot Training Train-the-Trainer Evaluation Survey.
18
1
15/60
5
18
1
15/60
5
18
1
20/60
6
18
1
15/60
5
...........................................................
........................
........................
........................
121
Total ...........................................
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–11672 Filed 5–15–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0519]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How To Submit
Information in Electronic Format to
Center for Veterinary Medicine Using
the Food and Drug Administration’s
Electronic Submission Gateway
BILLING CODE 4163–18–P
tkelley on DSK3SPTVN1PROD with NOTICES
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
SUMMARY:
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
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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 existing reporting requests in CVM
Guidance #108, ‘‘How to Register with
the CVM Electronic Submission System
to Submit Information in Electronic
Format using the FDA Electronic
Submissions Gateway.’’
DATES: Submit either electronic or
written comments on the collection of
information by July 15, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
E:\FR\FM\16MYN1.SGM
16MYN1
28852
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
Guidance for Industry #108 on How To
Submit Information in Electronic
Format to CVM Using the FDA
Electronic Submission Gateway—21
CFR 11.2 (OMB Control Number 0910–
0454)—Extension
CVM accepts certain types of
submissions electronically with no
requirement for a paper copy. These
types of documents are listed in public
docket 97S–0251 as required by 21 CFR
11.2. CVM’s ability to receive and
process information submitted
electronically is limited by its current
information technology capabilities and
the requirements of the Electronic
Records; Electronic Signatures final
regulation. CVM’s guidance entitled
‘‘Guidance for Industry 108: How to
Submit Information in Electronic
Format to CVM Using the FDA
Electronic Submission Gateway’’
outlines general standards to be used for
the submission of any information by
email. The likely respondents are
sponsors for new animal drug
applications.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
21 CFR Part and form FDA
§ 11.2; Form FDA 3538 .........
1 There
65
[FR Doc. 2013–11632 Filed 5–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed; Extension
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
Total annual
responses
2.4
156
Average burden
per response
0.08 (5 minutes) ...................
Total hours
13 (Rounded from 12.5)
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
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
SUMMARY:
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
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
extending OMB approval on the existing
recordkeeping requirements for this
information collection, regarding animal
proteins prohibited in ruminant feed.
DATES: Submit either electronic or
written comments on the collection of
information by July 15, 2013.
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 00057
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
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 extension of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28851-28852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11632]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0519]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How To Submit Information in
Electronic Format to Center for Veterinary Medicine Using the Food and
Drug Administration's Electronic Submission Gateway
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 existing reporting
requests in CVM Guidance 108, ``How to Register with the CVM
Electronic Submission System to Submit Information in Electronic Format
using the FDA Electronic Submissions Gateway.''
DATES: Submit either electronic or written comments on the collection
of information by July 15, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of
[[Page 28852]]
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@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.
Guidance for Industry 108 on How To Submit Information in
Electronic Format to CVM Using the FDA Electronic Submission Gateway--
21 CFR 11.2 (OMB Control Number 0910-0454)--Extension
CVM accepts certain types of submissions electronically with no
requirement for a paper copy. These types of documents are listed in
public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to
receive and process information submitted electronically is limited by
its current information technology capabilities and the requirements of
the Electronic Records; Electronic Signatures final regulation. CVM's
guidance entitled ``Guidance for Industry 108: How to Submit
Information in Electronic Format to CVM Using the FDA Electronic
Submission Gateway'' outlines general standards to be used for the
submission of any information by email. The likely respondents are
sponsors for new animal drug applications.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Part and form FDA Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. 11.2; Form FDA 3538... 65 2.4 156 0.08 (5 minutes) 13 (Rounded
from 12.5)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11632 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P
