Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures, 6447-6448 [05-2298]
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Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
6447
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
7,915
21 CFR Part
1
7,915
113 and 114
1There
250
Total Hours
1,978,750
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for §§ 108.25(d)
and 108.35(d) and (e) is insignificant
because notification of spoilage, process
deviation or contamination of product
in distribution occurs less than once a
year. Most firms discover these
problems before the product is
distributed and, therefore, are not
required to report the occurrence. To
avoid double-counting, estimates for
§§ 108.25(g) and 108.35(h) have not
been included because they merely
cross reference recordkeeping
requirements contained in parts 113 and
114.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2297 Filed 2–4–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0045]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Records; Electronic Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Hours per Record
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
information collection provisions
relating to FDA’s electronic records and
electronic signatures.
DATES: Submit written or electronic
comments on the collection of
information by April 8, 2005.
ADDRESSES: Submit electronic
comments on the collection of
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
information to: https://www.fda.gov/
dockets/ecomments. 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:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Electronic Records; Electronic
Signatures—(21 CFR Part 11) (OMB
Control Number 0910–0303)—Extension
FDA regulations in part 11 (21 CFR
part 11) provide criteria for acceptance
of electronic records; electronic
signatures, and handwritten signatures
executed to electronic records as
equivalent to paper records. Under these
regulations, records and reports may be
submitted to FDA electronically
provided the agency has stated our
ability to accept the records
electronically in an agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require standard operating procedures
(SOPs) to assure appropriate use of, and
precautions for, systems using
electronic records and signatures: (1)
Section 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) section
11.30 specifies procedures and controls
for persons who use open systems to
create, modify, maintain, or transmit
electronic records; (3) section 11.50
specifies procedures and controls for
persons who use electronic signatures;
and (4) section 11.300 specifies controls
to ensure the security and integrity of
electronic signatures based upon use of
identification codes in combination
with passwords. The reporting
provision (§ 11.100) requires persons to
certify in writing to FDA that they will
regard electronic signatures used in
their systems as the legally binding
equivalent of traditional handwritten
signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of SOPs,
validation, and certification. The agency
anticipates the use of electronic media
will substantially reduce the paperwork
burden associated with maintaining
FDA required records.
The respondents will be businesses
and other for-profit organizations, state
or local governments, Federal agencies,
and nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\07FEN1.SGM
07FEN1
6448
Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
11.100
1There
Annual Frequency
per Response
No. of Respondents
4,500
Total Annual Responses
1
Hours per Response
4,500
Total Hours
1
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Annual
Frequency of
Recordkeeping
11.10
2,500
1
2,500
20
45,000
11.30
2,500
1
2,500
20
45,000
11.50
4,500
1
4,500
20
90,000
11.300
4,500
1
4,500
20
90,000
21 CFR Section
Total Annual
Records
Hours per
Recordkeeper
Total
1 There
270,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2298 Filed 2–4–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N–0312]
Animal Feed Safety System: A
Comprehensive Risk-Based Safety
Program for the Manufacture and
Distribution of Animal Feeds; Notice of
Public Meeting
AGENCY:
Total Hours
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss our progress
on development of a comprehensive,
risk-based Animal Feed Safety System
(AFSS) describing how animal feeds
(individual ingredients and mixed
feeds) should be manufactured,
distributed, and used to minimize risks
to humans and animals. We are seeking
comments and assistance in our
consideration of this safety program to
effectively minimize the hazards to
public health posed by animal feed
products.
Date and Time: The public meting
will be held on Tuesday, April 5, 2005,
from 8 a.m. to 5 p.m., and Wednesday,
April 6, 2005, from 8 a.m. to 12:15 p.m.
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
You may submit written or electronic
comments at any time, but they would
be most helpful if received on or before
March 4, 2005.
Location: The public meeting will be
held at The Crowne Plaza, 655 North
108th Ave., Omaha, NE 68154, 402–
496–0850.
ADDRESSES: You may submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments. You can view comments
FDA has received on the Internet at
https://www.fda.gov/ohrms/dockets/.
Contacts:
For General Information: Zoe Gill,
Center for Veterinary Medicine (HFV–
226), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,
240–453–6867, FAX: 240–453–6882, or
e-mail: zoe.gill@fda.gov.
For Information About Registration:
Brenda Boateng, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6850,
FAX: 240–453–6882, or e-mail:
brenda.boateng@fda.gov.
Registration: Registration forms are
available on the Division of Dockets
Management Web site at https://
www.accessdata.fda.gov/scripts/oc/
dockets/meetings/meetingdocket.cfm.
Although there is no registration fee for
this meeting, registration is required.
Due to limited meeting space, and to
permit the agency to adequately prepare
for the meeting, early registration is
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
strongly encouraged. We are asking that
registration occur by March 11, 2005.
You may register by telephone, fax, or
e-mail by contacting Brenda Boateng
(see Contacts).
If you need special accommodations
due to a disability, please contact Toni
Wooten at 301–595–0796 or by e-mail at
toni.wooten@fda.gov at least 7 days in
advance of the meeting.
Transcripts: You may request a
transcript of the meeting’s general
session in writing from the Freedom of
Information Office (HFI–35), Food and
Drug Administration, 5600 Fishers
Lane, rm. 12A–16, Rockville, MD 20857.
The transcript will not include the
individual breakout sessions, although
their summaries will be included in the
general session transcript. The
transcript of the public meeting will be
available after the meeting, at a cost of
10 cents per page. You may also
examine the transcript of the meeting at
the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday and on
the CVM Web site at https://
www.fda.gov/cvm.
SUPPLEMENTARY INFORMATION:
I. Background
We envision the AFSS as an umbrella
regulatory program aimed at protecting
human and animal health, It is intended
to cover the labeling, production, and
distribution of all feed ingredients and
mixed feeds at all stages of manufacture,
distribution, and use.
On September 23 and 24, 2003, we
held a public meeting in Herndon, VA
to discuss the AFSS. The public meeting
included active participation of people
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6447-6448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0045]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Records; Electronic Signatures
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 information collection
provisions relating to FDA's electronic records and electronic
signatures.
DATES: Submit written or electronic comments on the collection of
information by April 8, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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.
Electronic Records; Electronic Signatures--(21 CFR Part 11) (OMB
Control Number 0910-0303)--Extension
FDA regulations in part 11 (21 CFR part 11) provide criteria for
acceptance of electronic records; electronic signatures, and
handwritten signatures executed to electronic records as equivalent to
paper records. Under these regulations, records and reports may be
submitted to FDA electronically provided the agency has stated our
ability to accept the records electronically in an agency-established
public docket and that the other requirements of part 11 are met.
The recordkeeping provisions in part 11 (Sec. Sec. 11.10, 11.30,
11.50, and 11.300) require standard operating procedures (SOPs) to
assure appropriate use of, and precautions for, systems using
electronic records and signatures: (1) Section 11.10 specifies
procedures and controls for persons who use closed systems to create,
modify, maintain, or transmit electronic records; (2) section 11.30
specifies procedures and controls for persons who use open systems to
create, modify, maintain, or transmit electronic records; (3) section
11.50 specifies procedures and controls for persons who use electronic
signatures; and (4) section 11.300 specifies controls to ensure the
security and integrity of electronic signatures based upon use of
identification codes in combination with passwords. The reporting
provision (Sec. 11.100) requires persons to certify in writing to FDA
that they will regard electronic signatures used in their systems as
the legally binding equivalent of traditional handwritten signatures.
The burden created by the information collection provision of this
regulation is a one-time burden associated with the creation of SOPs,
validation, and certification. The agency anticipates the use of
electronic media will substantially reduce the paperwork burden
associated with maintaining FDA required records.
The respondents will be businesses and other for-profit
organizations, state or local governments, Federal agencies, and
nonprofit institutions.
FDA estimates the burden of this collection of information as
follows:
[[Page 6448]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
21 CFR Section No. of Respondents per Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100 4,500 1 4,500 1 4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 of Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
11.10 2,500 1 2,500 20 45,000
----------------------------------------------------------------------------------------------------------------
11.30 2,500 1 2,500 20 45,000
----------------------------------------------------------------------------------------------------------------
11.50 4,500 1 4,500 20 90,000
----------------------------------------------------------------------------------------------------------------
11.300 4,500 1 4,500 20 90,000
----------------------------------------------------------------------------------------------------------------
Total 270,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2298 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S
