Training Program for Regulatory Project Managers; Information Available to Industry, 9028-9029 [2011-3461]
Download as PDF
<![CDATA[
9028
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, 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:
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3474 Filed 2–15–11; 8:45 am]
BILLING CODE 4160–01–P
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0520]
Guidance for Industry: Potency Tests
for Cellular and Gene Therapy
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Potency Tests
for Cellular and Gene Therapy Products’’
dated January 2011. The guidance
document provides manufacturers of
cellular and gene therapy (CGT)
products with recommendations for
developing tests to measure potency.
The recommendations are intended to
clarify the potency information that
could support an investigational new
drug application (IND) or a biologics
license application (BLA). The guidance
announced in this notice finalizes the
draft guidance of the same title dated
October 2008.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (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 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 guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Potency Tests for Cellular and
Gene Therapy Products’’ dated January
2011. The guidance document provides
manufacturers of cellular and gene
therapy products with
recommendations for developing tests to
measure potency. The recommendations
are intended to clarify the potency
information needed to support an IND
or a BLA. Because potency
measurements are designed specifically
for a particular product, the guidance
does not make recommendations
regarding specific types of potency
assays, nor does it propose acceptance
criteria for product release.
In the Federal Register of October 9,
2008 (73 FR 59635), FDA announced the
availability of the draft guidance of the
same title. FDA received several
comments on the draft guidance and
those comments were considered as the
guidance was finalized. A summary of
changes includes the addition of text
related to adjuvant testing and
modification of assay parameters for
validation studies. In addition, editorial
and formatting changes were made to
improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated October 2008.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
approved under 0910–0014; the
collections of information in 21 CFR
part 601 has been approved under
0910–0338.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: February 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3462 Filed 2–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0069]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the Agency
by April 18, 2011.
FOR FURTHER INFORMATION CONTACT: Beth
Duvall-Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993–0002, 301–
SUMMARY:
E:\FR\FM\16FEN1.SGM
16FEN1
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
professionally by gaining a better
understanding of industry processes and
procedures.
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
mstockstill on DSKH9S0YB1PROD with NOTICES
796–0700, e-mail:
elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Selection
will also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
regions. Firms interested in offering a
site tour or learning more about this
training opportunity should respond by
submitting a proposed agenda to Beth
Duvall-Miller (see DATES and FOR
FURTHER INFORMATION CONTACT).
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3461 Filed 2–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB), under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
9029
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
(OMB No. 0915–0307)—Extension
Title XXVI, Section 2671 of the Public
Health Service (PHS) Act, as amended
by the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White HIV/
AIDS Program), requires that grantees
expend 75 percent of Parts A, B, and C
Funds on core medical services,
including antiretroviral drugs for
individuals with HIV/AIDS, identified
and eligible under the legislation. In
order for Grantees under Parts A, B, and
C to be exempted from the 75 percent
core medical services requirement, they
must request and receive a waiver from
HRSA, as required in the Act.
HRSA utilizes standards for granting
waivers of the core medical services
requirement for the Ryan White HIV/
AIDS Program. These standards meet
the intent of the Ryan White HIV/AIDS
Program to increase access to core
medical services, including
antiretroviral drugs for persons with
HIV/AIDS, and to ensure that grantees
receiving waivers demonstrate the
availability of such services for
individuals with HIV/AIDS, identified
and eligible under Title XXVI of the
PHS Act. The core medical services
waiver uniform standard and waiver
request process will apply to Ryan
White HIV/AIDS Program Grant Awards
under Parts A, B, and C of Title XXVI
of the PHS Act. Core medical services
waivers will be effective for a 1-year
period that is consistent with the grant
award period.
Grantees must submit a waiver
request with the annual grant
application containing the certifications
and documentation which will be
utilized by HRSA in making
determinations regarding waiver
requests. Grantees must provide
evidence that all of the core medical
services listed in the statute, regardless
of whether such services are funded by
the Ryan White HIV/AIDS Program, are
available to all individuals with HIV/
AIDS, identified and eligible under Title
XXVI of the PHS Act in the service area
within 30 days.
The annual estimate of burden is as
follows:
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9028-9029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0069]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may submit proposed agendas to the
Agency by April 18, 2011.
FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-
[[Page 9029]]
796-0700, e-mail: elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
significantly enhance review efficiency and review quality by providing
the staff with a better understanding of the pharmaceutical industry
and its operations. To this end, CDER is continuing its training
program to give regulatory project managers the opportunity to tour
pharmaceutical facilities. The goals are to provide the following: (1)
Firsthand exposure to industry's drug development processes and (2) a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the site tours will be the
responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms interested in offering a site tour
or learning more about this training opportunity should respond by
submitting a proposed agenda to Beth Duvall-Miller (see DATES and FOR
FURTHER INFORMATION CONTACT).
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3461 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P
