Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 24818-24819 [05-9370]
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24818
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
For scientific/research issues, contact:
Susan Chu, PhD, MSPH, Extramural
Program Official, National
Immunization Program, Centers for
Disease Control and Prevention,
National Immunization Program, MS E–
05, 1600 Clifton Road NE, Atlanta, GA
30333. Telephone: 404–639–8727. Email: SChu@cdc.gov.
For questions about peer review,
contact: Mary Lerchen, DrPH, Scientific
Review Administrator, CDC/Office of
Public Health Research, One West Court
Square, Suite 7000, MS D–72.
Telephone: 404–371–5277. Fax: 404–
371–5215. E-mail: MLerchen@cdc.gov.
For financial, grants management, or
budget assistance, contact: Yolanda
Ingram-Sledge, Grants Management
Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
GA 30341. Telephone: 770–488–2787.
E-mail: Ysledge@cdc.gov.
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: www.cdc.gov. Click on
‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements.’’
Dated: May 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–9371 Filed 5–10–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0045]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
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 10,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
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
provisions (§ 11.100) require 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 are businesses and
other for-profit organizations, State or
local governments, Federal agencies,
and nonprofit institutions.
In the Federal Register of February 7,
2005 (70 FR 6447), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
11.100
1There
Annual Frequency
per Response
4,500
1
Total Annual
Responses
Hours per
Response
4,500
1
are no capital costs or operating and maintenance costs associated with this collection of information.
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16:48 May 10, 2005
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Total Hours
11MYN1
4,500
24819
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
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
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9370 Filed 5–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0021]
International Conference on
Harmonisation; Draft Guidance on Q8
Pharmaceutical Development;
Availability; Reopening of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
June 11, 2005, the comment period for
the notice, published in the Federal
Register of February 9, 2005 (70 FR
6888). In the notice, FDA announced the
availability of a draft guidance entitled
‘‘Q8 Pharmaceutical Development.’’
FDA is reopening the comment period
to provide additional time for public
comment consistent with the time for
comment provided by other ICH
regulatory entities.
DATES: Submit written or electronic
comments on the draft guidance by June
11, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written comments
on the draft guidance 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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information (HFD–
SUMMARY:
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send two
self-addressed adhesive labels to assist
the office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Ajaz
Hussain, Center for Drug Evaluation
and Research (HFD–3), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–
594–2847; or Christopher Joneckis,
Center for Biologics Evaluation and
Research (HFM–1), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
435–5681.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 9,
2004 (70 FR 6888), FDA announced the
availability of a draft guidance entitled
‘‘Q8 Pharmaceutical Development,’’
prepared under the auspices of the ICH.
The draft guidance provides
recommendations to sponsors
concerning pharmaceutical studies as
defined in section 3.2.P.2 of module 3
of the Common Technical Document
(CTD).
Interested persons were given until
April 11, 2005, to submit comments on
the draft guidance.
FDA has decided to reopen the
comment period on the draft guidance
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Frm 00055
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until June 11, 2005, to allow the public
additional time to review and comment
on the contents and to be consistent
with the time for comment provided by
other ICH regulatory entities.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m. Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9369 Filed 5–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Program Exclusions: April 2005
AGENCY:
Office of Inspector General,
HHS.
ACTION:
Notice of program exclusions.
During the month of April 2005, the
HHS Office of Inspector General
imposed exclusions in the cases set
forth below. When an exclusions is
E:\FR\FM\11MYN1.SGM
11MYN1
]]>Agencies
[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24818-24819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0045]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Records;
Electronic Signatures
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
10, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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.
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
provisions (Sec. 11.100) require 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 are businesses and other for-profit organizations,
State or local governments, Federal agencies, and nonprofit
institutions.
In the Federal Register of February 7, 2005 (70 FR 6447), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses 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.
[[Page 24819]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
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: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9370 Filed 5-10-05; 8:45 am]
BILLING CODE 4160-01-S
