Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Use E-Mail To Submit a Study Protocol, 7437-7438 [E7-2577]
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7437
Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices
costs other than the amount of time
required to respond to the survey.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Data collection instrument
Average burden per response
(in hrs)
Responses/
respondent
Average annual burden
hours
Satisfaction survey (callers) .............................................................................
Satisfaction survey (e-mail inquiries) ...............................................................
Follow up survey ..............................................................................................
Key informant survey .......................................................................................
Postcard survey for bulk mailing .....................................................................
Postcard survey for individual publications .....................................................
Web survey for e-mail publication orders ........................................................
Web survey for internet publications ...............................................................
Special event/Outreach survey—General Public ............................................
Special event/Outreach survey—Professionals ...............................................
Emergency response survey—Level 1 emergency—General Public .............
Emergency response survey—Level 1 emergency—Professionals ................
Emergency response survey—Level 2 emergency—General Public .............
Emergency response survey—Level 2 emergency—Professionals ................
Emergency response survey—Level 3 emergency—General Public .............
Emergency response survey—Level 3 emergency—Professional .................
Emergency response survey—Level 4 emergency—General Public .............
Emergency response survey—Level 4 emergency—Professional .................
25,000
330
3,125
100
950
2,100
1,000
950
25,600
10,400
31,151
7,459
57,579
51,821
351,863
316,678
645,630
596,504
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
3/60
3/60
7/60
7/60
1/60
1/60
1/60
1/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
1,250
17
365
12
16
35
17
16
2,133
867
2596
622
4798
4318
29,322
26,390
53,803
49,709
Total Burden Hours ..................................................................................
........................
........................
........................
176,286
Dated: February 6, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–2637 Filed 2–14–07; 8:45 am]
BILLING CODE 4163–18–P
published with an error in titles
referring to an FDA form number in two
places in the document. This document
corrects those errors.
DATES:
February 15, 2007.
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
Food and Drug Administration
[Docket No. 2006N–0430]
In the
Federal Register of Friday, February 2,
2007, the following corrections are
made on page 5057:
1. In the first column, in the ninth
line of the title of the document, the
phrase ‘‘Forms FDA 456h’’ is corrected
to read ‘‘Forms FDA 356h’’.
2. In the second column, in the
SUPPLEMENTARY INFORMATION section of
the document, in the sixth line of the
title, the phrase ‘‘Forms FDA 456h’’ is
corrected to read ‘‘Forms FDA 356h’’.
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of February 2, 2007 (72 FR
5057). The document announced that an
opportunity for public comment on a
proposed collection of information had
been submitted to the Office of
Management and Budget for review and
clearance under the Paperwork
Reduction Act of 1995. The notice
ycherry on PROD1PC64 with NOTICES
SUMMARY:
VerDate Aug<31>2005
18:37 Feb 14, 2007
Jkt 211001
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2576 Filed 2–14–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. 2006N–0436]
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on How To Use E-Mail To
Submit a Study Protocol
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 March 19,
2007.
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.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
E:\FR\FM\15FEN1.SGM
15FEN1
7438
Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices
Lane, Rockville, MD 20857, 301–827–
1472.
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 Use
E-Mail To Submit a Study Protocol’’—
21 CFR 58.120; 21 CFR 514.117(b);
(OMB Control Number 0910–0524)—
Extension
Protocols for nonclinical laboratory
studies (safety studies), are required
under 21 CFR 58.120 for approval of
new animal drugs. Protocols for
adequate and well-controlled
effectiveness studies are required under
21 CFR 514.117(b). Upon request by the
animal drug sponsors, the Center for
Veterinary Medicine (CVM), reviews
protocols for safety and effectiveness
studies that CVM and the sponsor
consider to be an essential part of the
basis for making the decision to approve
or not approve an animal drug
application or supplemental animal
drug application. Establishing a process
for acceptance of the electronic
submission of protocols for studies
conducted by sponsors in support of
new animal drug applications (NADAs),
is part of CVM’s ongoing initiative to
provide a method for paperless
submissions. Sponsors may submit
protocols to CVM in paper format.
CVM’s guidance on how to submit a
study protocol permits sponsors to
submit a protocol without data as an email attachment via the Internet. CVM’s
guidance on how to submit a study
protocol electronically implements
provisions of the Government
Paperwork Elimination Act (GPEA). The
GPEA required Federal agencies, by
October 21, 2003, to provide for the: (1)
Option of the electronic maintenance,
submission, or disclosure of
information, if practicable, as a
substitution for paper; and (2) use and
acceptance of electronic signatures,
where applicable.
FDA is also seeking an extension of an
existing paperwork clearance for form
FDA 3536 to facilitate the use of
electronic submission of protocols. This
collection of information is for the
benefit of animal drug sponsors, giving
them the flexibility to submit data for
review via the Internet.
In the Federal Register of November
8, 2006 (71 FR 65534), FDA published
a 60-day notice soliciting public
comment on the proposed collection of
information requirements. In response
to that notice, no comments were
received.
The likely respondents for this
collection of information are sponsors of
NADAs.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section/ Form No.
514.117 ( b)
58.120 / Form 3536
1There
Annual Frequency
per Response
25
Total Annual
Responses2
4.2
Hours per
Response
103
Total Hours
0.20
20.6
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between July 1, 2005, and June 30, 2006.
2Electronic
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
submissions (25). The number of total
annual responses is based on a review
of the actual number of such
submissions made between July 1, 2005,
and June 30, 2006. 103 x hours per
response (.20) = 20.6 total hours.
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2577 Filed 2–14–07; 8:45 am]
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.
Fax written comments on the
collection of information by March 19,
2007.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
ADDRESSES:
BILLING CODE 4160–01–S
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
ycherry on PROD1PC64 with NOTICES
[Docket No. 2006N–0381]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mammography
Quality Standards Act Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:37 Feb 14, 2007
Jkt 211001
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:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
The Mammography Quality Standards
Act Requirements—21 CFR Part 900
(OMB Control Number 0910–0309)—
Extension
Mammography Quality Standards Act
requires the establishment of a Federal
certification and inspection program for
mammography facilities; regulations
and standards for accreditation and
certification bodies for mammography
facilities, and standards for
mammography equipment, personnel,
and practices, including quality
assurance. The intent of these
regulations is to ensure safe, reliable,
and accurate mammography on a
nationwide level.
Under the regulations, as a first step
in becoming certified, mammography
facilities must become accredited by an
FDA approved accreditation body. This
requires undergoing a review of their
clinical images and providing the
accreditation body with information
showing that they meet the equipment,
personnel, quality assurance and quality
control standards, and have a medical
reporting and recordkeeping program, a
medical outcomes audit program, and a
consumer compliant mechanism. On the
basis of this accreditation, facilities are
then certified by FDA or an FDA-
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7437-7438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2577]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0436]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on How To Use E-Mail To Submit a Study Protocol
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 March
19, 2007.
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.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers
[[Page 7438]]
Lane, Rockville, MD 20857, 301-827-1472.
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 Use E-Mail To Submit a Study
Protocol''--21 CFR 58.120; 21 CFR 514.117(b); (OMB Control Number 0910-
0524)--Extension
Protocols for nonclinical laboratory studies (safety studies), are
required under 21 CFR 58.120 for approval of new animal drugs.
Protocols for adequate and well-controlled effectiveness studies are
required under 21 CFR 514.117(b). Upon request by the animal drug
sponsors, the Center for Veterinary Medicine (CVM), reviews protocols
for safety and effectiveness studies that CVM and the sponsor consider
to be an essential part of the basis for making the decision to approve
or not approve an animal drug application or supplemental animal drug
application. Establishing a process for acceptance of the electronic
submission of protocols for studies conducted by sponsors in support of
new animal drug applications (NADAs), is part of CVM's ongoing
initiative to provide a method for paperless submissions. Sponsors may
submit protocols to CVM in paper format. CVM's guidance on how to
submit a study protocol permits sponsors to submit a protocol without
data as an e-mail attachment via the Internet. CVM's guidance on how to
submit a study protocol electronically implements provisions of the
Government Paperwork Elimination Act (GPEA). The GPEA required Federal
agencies, by October 21, 2003, to provide for the: (1) Option of the
electronic maintenance, submission, or disclosure of information, if
practicable, as a substitution for paper; and (2) use and acceptance of
electronic signatures, where applicable.
FDA is also seeking an extension of an existing paperwork clearance
for form FDA 3536 to facilitate the use of electronic submission of
protocols. This collection of information is for the benefit of animal
drug sponsors, giving them the flexibility to submit data for review
via the Internet.
In the Federal Register of November 8, 2006 (71 FR 65534), FDA
published a 60-day notice soliciting public comment on the proposed
collection of information requirements. In response to that notice, no
comments were received.
The likely respondents for this collection of information are
sponsors of NADAs.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section/ Form No. Respondents per Response Responses\2\ Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.117 ( b) 25 4.2 103 0.20 20.6
58.120 / Form 3536
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Electronic submissions received between July 1, 2005, and June 30, 2006.
The number of respondents in table 1 of this document is the number
of sponsors registered to make electronic submissions (25). The number
of total annual responses is based on a review of the actual number of
such submissions made between July 1, 2005, and June 30, 2006. 103 x
hours per response (.20) = 20.6 total hours.
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2577 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S
