Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability, 29760-29761 [E8-11516]
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Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Notices
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
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before submitting the collection to OMB
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of the proposed collection of
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With respect to the following
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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
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of automated collection techniques,
when appropriate, and other forms of
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Survey to Evaluate FDA’s Food Defense
Awareness Initiative ALERT
In July 2006, FDA announced its Food
Defense Awareness Initiative, called
ALERT (the letters stand for the five key
components of the initiative: (assure,
look, employees, report, and threat). The
ALERT initiative is intended to raise the
awareness of State and local government
agencies and the food industry
regarding food defense issues. ALERT
identifies five key points that industry
and businesses can use to decrease the
risk of intentional food contamination at
their facility. The ALERT Web-based
training module and more information
on ALERT are available at
www.cfsan.fda.gov/~dms/defterr.html.
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393 (b)(2)), FDA is authorized to
conduct research relating to foods and
to conduct educational and public
information programs relating to the
safety of the nation’s food supply.
Under this authority, FDA is planning to
conduct a survey of first line
supervisors working in a range of
capacities in the food industry about
their awareness and perceptions of the
agency’s ALERT initiative and the
ALERT initiative informational
materials. The purpose of the survey is
to help FDA evaluate ALERT
informational materials and to gauge
whether the materials succeed in
informing food industry supervisory
employees about the risk of intentional
food contamination and in motivating
them to engage in protective behaviors.
The survey results will be used to assess
how knowledge and awareness, threat
perceptions, attitudes, norms, benefits
and barriers affect the implementation
of the ALERT initiative.
The data will be collected using a
Web-based questionnaire. The survey
will employ a stratified, cluster
sampling design. Using industry
networks and listings, we will randomly
sample from databases of eight industry
groups (regulators, growers, packers,
processors, warehousers, transporters,
retailers, and food service operators).
We will stratify within groups by
organization size (small, medium, and
large) based on number of employees on
the payroll, for a total random sample of
200 organizations. Participation in the
survey is voluntary. Cognitive
interviews and a pre-test will be
conducted prior to fielding the survey.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Questionnaire
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
Cognitive Interviews
10
10
10
1
10
Pre-tests
10
1
10
.4
4
200
1
200
.4
80
Survey
Total
rwilkins on PROD1PC63 with NOTICES
1 There
94
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with consumer surveys
similar to this proposed survey.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: May 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–11514 Filed 5–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0293]
Draft Guidance for Industry:
Considerations for Allogeneic
Pancreatic Islet Cell Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
VerDate Aug<31>2005
17:03 May 21, 2008
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PO 00000
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E:\FR\FM\22MYN1.SGM
22MYN1
Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
availability of a draft document entitled
‘‘Guidance for Industry: Considerations
for Allogeneic Pancreatic Islet Cell
Products’’ dated May 2008. The draft
guidance document is intended to
provide recommendations to
manufacturers, sponsors, and clinical
investigators involved in the
transplantation of allogeneic pancreatic
islet cell products for clinical
investigations of the treatment of type 1
diabetes mellitus. The draft guidance is
intended to provide assistance by
identifying the types of data and
information obtained during
investigational new drug studies that
may be helpful in establishing the
safety, purity, and potency of a
biological product in a biologics license
application (BLA).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by August 20, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Considerations for Allogeneic
Pancreatic Islet Cell Products’’ dated
May 2008. The draft guidance document
is intended to provide recommendations
to manufacturers, sponsors, and clinical
investigators involved in the
VerDate Aug<31>2005
17:03 May 21, 2008
Jkt 214001
transplantation of allogeneic pancreatic
islet cell products for clinical
investigations of the treatment of type 1
diabetes mellitus. The draft guidance is
intended to provide assistance with the
types of data and information that may
be obtained during investigational new
drug studies to assist in establishing the
safety, purity, and potency of a
biological product in a BLA. However,
the guidance is not intended to identify
all of the product, preclinical, and
clinical data that may be needed to
successfully support a BLA.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 211 has
been approved under 0910–0139; the
collections of information in 21 CFR
part 312 has been approved under
0910–0014; the collections of
information in 21 CFR parts 601 and
610 have been approved under 0910–
0338; and the collections of information
in 21 CFR part 1271 has been approved
under 0910–0543 and 0910–0559.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
29761
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–11516 Filed 5–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 24, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD, 301–
589–5200.
Contact Person: Elaine Ferguson,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
elaine.ferguson@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Notices]
[Pages 29760-29761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0293]
Draft Guidance for Industry: Considerations for Allogeneic
Pancreatic Islet Cell Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 29761]]
availability of a draft document entitled ``Guidance for Industry:
Considerations for Allogeneic Pancreatic Islet Cell Products'' dated
May 2008. The draft guidance document is intended to provide
recommendations to manufacturers, sponsors, and clinical investigators
involved in the transplantation of allogeneic pancreatic islet cell
products for clinical investigations of the treatment of type 1
diabetes mellitus. The draft guidance is intended to provide assistance
by identifying the types of data and information obtained during
investigational new drug studies that may be helpful in establishing
the safety, purity, and potency of a biological product in a biologics
license application (BLA).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by August 20, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
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.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet
Cell Products'' dated May 2008. The draft guidance document is intended
to provide recommendations to manufacturers, sponsors, and clinical
investigators involved in the transplantation of allogeneic pancreatic
islet cell products for clinical investigations of the treatment of
type 1 diabetes mellitus. The draft guidance is intended to provide
assistance with the types of data and information that may be obtained
during investigational new drug studies to assist in establishing the
safety, purity, and potency of a biological product in a BLA. However,
the guidance is not intended to identify all of the product,
preclinical, and clinical data that may be needed to successfully
support a BLA.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 211 has been approved under
0910-0139; the collections of information in 21 CFR part 312 has been
approved under 0910-0014; the collections of information in 21 CFR
parts 601 and 610 have been approved under 0910-0338; and the
collections of information in 21 CFR part 1271 has been approved under
0910-0543 and 0910-0559.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in the brackets in
the heading of this document. A copy of 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/cber/guidelines.htm or https://
www.regulations.gov.
Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11516 Filed 5-21-08; 8:45 am]
BILLING CODE 4160-01-S
