Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway, 27790 [2010-11808]
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27790
Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices
There are no Capital Costs, Operating
costs, and/or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Ms. Liz Elliott,
NIGMS, NIH, Natcher Building, Room
2AN–18H, 45 Center Drive, MSC 6200,
Bethesda, MD 20892–6200, or call nontoll-free number 301–594–2755 or email your request, including your
address to: elliotte@nigms.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: May 10, 2010.
Sally Lee,
Executive Officer, National Institute of
General Medical Sciences, National Institutes
of Health.
[FR Doc. 2010–11857 Filed 5–17–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0057]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on How to Submit Information
in Electronic Format to the Center for
Veterinary Medicine Using the FDA
Electronic Submission Gateway
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 June 17,
2010.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0454. Also
include the FDA docket number found
in brackets in the heading of this
document
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on How to
Submit Information in Electronic
Format to the Center for Veterinary
Medicine Using the FDA Electronic
Submission Gateway (OMB Control
Number 0910–0454)—Extension
The Center for Veterinary Medicine
(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: 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 e-mail. The likely
respondents are sponsors for new
animal drug applications.
In the Federal Register of February 5,
2010 (75 FR 6038), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/Form 3538
No. of
Respondents
11.2
1 There
Annual Frequency
per Response
40
Hours per
Respondent
Total Annual
Responses2
1.3
52
Total Hours
.08
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between January 1, 2008, and December 31, 2008.
mstockstill on DSKH9S0YB1PROD with NOTICES
2 Electronic
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
submissions (40). The number of total
annual responses is based on a review
of the actual number of such
submissions made between January 1,
2008, and December 31, 2008 (52 x
hours per response (.08) = 4.2 total
hours).
Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–11808 Filed 5–17–10; 8:45 am]
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[Federal Register Volume 75, Number 95 (Tuesday, May 18, 2010)]
[Notices]
[Page 27790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11808]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0057]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on How to Submit Information in Electronic Format to the Center for
Veterinary Medicine Using the FDA Electronic Submission Gateway
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 June
17, 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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0454.
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.,
P150-400B, 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.
Guidance for Industry on How to Submit Information in Electronic Format
to the Center for Veterinary Medicine Using the FDA Electronic
Submission Gateway (OMB Control Number 0910-0454)--Extension
The Center for Veterinary Medicine (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: 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 e-mail. The likely
respondents are sponsors for new animal drug applications.
In the Federal Register of February 5, 2010 (75 FR 6038), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Section/ No. of Annual Frequency Total Annual Hours per
Form 3538 Respondents per Response Responses\2\ Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
11.2 40 1.3 52 .08 4.2
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.
The number of respondents in table 1 of this document is the number
of sponsors registered to make electronic submissions (40). The number
of total annual responses is based on a review of the actual number of
such submissions made between January 1, 2008, and December 31, 2008
(52 x hours per response (.08) = 4.2 total hours).
Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11808 Filed 5-17-10; 8:45 am]
BILLING CODE 4160-01-S
