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Federal Register / Vol. 71, No.

76 / Thursday, April 20, 2006 / Notices 20409

change(s), if it previously identified the (1) Abide by the terms of the statement; DEPARTMENT OF HEALTH AND
workplaces in question (see paragraph five). and HUMAN SERVICES
8. Definitions of terms in the (2) Notify the employer in writing of his or
Nonprocurement Suspension and Debarment her conviction for a violation of a criminal Food and Drug Administration
common rule and Drug-Free Workplace drug statute occurring in the workplace no
common rule apply to this certification. later than five calendar days after such [Docket No. 2006N–0152]
Grantees’ attention is called, in particular, to conviction;
the following definitions from these rules:
(e) Notifying the agency in writing, within Preparation for International
Controlled substance means a controlled
substance in Schedules I through V of the
10 calendar days after receiving notice under Conference on Harmonization
Controlled Substances Act (21 U.S.C. 812) paragraph (d)(2) from an employee or Meetings in Yokohama, Japan; Public
and as further defined by regulation (21 CFR otherwise receiving actual notice of such Meeting
1308.11 through 1308.15); conviction. Employers of convicted
employees must provide notice, including AGENCY: Food and Drug Administration,
Conviction means a finding of guilt
(including a plea of nolo contendere) or position title, to every grant officer or other HHS.
imposition of sentence, or both, by any designee on whose grant activity the ACTION: Notice of meeting.
judicial body charged with the responsibility convicted employee was working, unless the
to determine violations of the Federal or Federal agency has designated a central point SUMMARY: The Food and Drug
State criminal drug statutes; for the receipt of such notices. Notice shall Administration (FDA) is announcing a
Criminal drug statute means a Federal or include the identification number(s) of each public meeting entitled ‘‘Preparation for
non-Federal criminal statute involving the affected grant; ICH meetings in Yokohama, Japan’’ to
manufacture, distribution, dispensing, use, or (f) Taking one of the following actions, provide information and receive
possession of any controlled substance; within 30 calendar days of receiving notice comments on the International
Employee means the employee of a grantee Conference on Harmonization (ICH) as
under paragraph (d)(2), with respect to any
directly engaged in the performance of work
employee who is so convicted — well as the upcoming meetings in
under a grant, including: (i) All direct charge
employees; (ii) All indirect charge employees (1) Taking appropriate personnel action Yokohama, Japan. The topics to be
unless their impact or involvement is against such an employee, up to and discussed are the topics for discussion
insignificant to the performance of the grant; including termination, consistent with the at the forthcoming ICH Steering
and, (iii) Temporary personnel and requirements of the Rehabilitation Act of Committee Meeting. The purpose of the
consultants who are directly engaged in the 1973, as amended; or meeting is to solicit public input prior
performance of work under the grant and (2) Requiring such employee to participate to the next Steering Committee and
who are on the grantee’s payroll. This satisfactorily in a drug abuse assistance or Expert Working Groups meetings in
definition does not include workers not on rehabilitation program approved for such Yokohama, Japan on June 5 through 8,
the payroll of the grantee (e.g., volunteers, purposes by a Federal, State, or local health, 2006, at which discussion of the topics
even if used to meet a matching requirement; law enforcement, or other appropriate
consultants or independent contractors not
underway and the future of ICH will
agency; continue.
on the grantee’s payroll; or employees of (g) Making a good faith effort to continue
subrecipients or subcontractors in covered Date and Time: The meeting will be
to maintain a drug-free workplace through held on Monday, May 8, 2006, from 9:30
workplaces).
implementation of paragraphs (a), (b), (c), (d),
a.m. to 12:30 p.m.
Certification Regarding Drug-Free (e) and (f).
Workplace Requirements
Location: The meeting will be held at
(B) The grantee may insert in the space
5600 Fishers Lane, 3rd floor, Maryland
Alternate I. (Grantees Other Than provided below the site(s) for the
performance of work done in connection
Conference Room, Rockville, MD 20857.
Individuals) For security reasons, all attendees are
with the specific grant:
The grantee certifies that it will or will asked to arrive no later than 9:25 a.m.,
Place of Performance (Street address, city,
continue to provide a drug-free workplace by: as you will be escorted from the front
(a) Publishing a statement notifying county, state, zip code)
lllllllllllllllllllll entrance of 5600 Fishers Lane to the
employees that the unlawful manufacture, Maryland Conference Room.
distribution, dispensing, possession, or use of lllllllllllllllllllll
a controlled substance is prohibited in the Check if there are workplaces on file that
Contact Person: All participants must
grantee’s workplace and specifying the are not identified here. register with Sema Hashemi, Office of
actions that will be taken against employees the Commissioner, Food and Drug
for violation of such prohibition; Alternate II. (Grantees Who Are Individuals) Administration, 5600 Fishers Lane,
(b) Establishing an ongoing drug-free (a) The grantee certifies that, as a condition Rockville, MD 20857, e-mail:
awareness program to inform employees of the grant, he or she will not engage in the Sema.Hashemi@fda.hhs.gov or FAX:
about— unlawful manufacture, distribution, 301–480–0716.
(1) The dangers of drug abuse in the dispensing, possession, or use of a controlled Registration and Requests for Oral
workplace; substance in conducting any activity with the Presentations: Send registration
(2) The grantee’s policy of maintaining a grant;
drug-free workplace;
information (including name, title, firm
(b) If convicted of a criminal drug offense name, address, telephone, and fax
(3) Any available drug counseling,
rehabilitation, and employee assistance resulting from a violation occurring during number), written material and requests
programs; and the conduct of any grant activity, he or she to make oral presentations, to the
(4) The penalties that may be imposed will report the conviction, in writing, within contact person by May 1, 2006.
upon employees for drug abuse violations 10 calendar days of the conviction, to every If you need special accommodations
occurring in the workplace; grant officer or other designee, unless the due to a disability, please contact Sema
(c) Making it a requirement that each Federal agency designates a central point for Hashemi at least 7 days in advance.
hsrobinson on PROD1PC61 with NOTICES

employee to be engaged in the performance the receipt of such notices. When notice is
Transcripts: Transcripts of the
of the grant be given a copy of the statement made to such a central point, it shall include
required by paragraph (a);
meeting may be requested in writing
the identification number(s) of each affected
(d) Notifying the employee in the statement grant.
from the Freedom of Information Office
required by paragraph (a) that, as a condition (HFI–35), Food and Drug
of employment under the grant, the employee [FR Doc. E6–5906 Filed 4–19–06; 8:45 am] Administration, 5600 Fishers Lane, rm.
will— BILLING CODE 4184–01–P 12A–16, Rockville, MD 20857,

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20410 Federal Register / Vol. 71, No. 76 / Thursday, April 20, 2006 / Notices

approximately 15 working days after the process has achieved significant 3506(c)(2)(A) of the Paperwork
meeting at a cost of 10 cents per page. harmonization of the technical Reduction Act, for opportunity for
SUPPLEMENTARY INFORMATION: The ICH requirements for the approval of public comment on proposed data
was established in 1990 as a joint pharmaceuticals for human use in the collection projects, the Office of Dietary
regulatory/industry project to improve, three ICH regions. Supplements (ODS), at the National
through harmonization, the efficiency of The current ICH process and structure Institutes of Health (NIH) is soliciting
the process for developing and can be found at the following Web site: public comments on the subject
registering new medicinal products in http://www.ich.org. proposal.
Europe, Japan and the United States Interested persons may present data,
information, or views orally or in Proposed Collection
without compromising the regulatory
obligations of safety and effectiveness. writing, on issues pending at the public Title: ODS Assessment of Dietary
In recent years, many important meeting. Oral presentations from the Supplement Education.
initiatives have been undertaken by public will be scheduled between Type of Information Collection
regulatory authorities and industry approximately 11:30 a.m. and 12:30 Request: New data collection.
associations to promote international p.m. Time allotted for oral presentations Need and Use of Information
harmonization of regulatory may be limited to 10 minutes. Those Collection: The mission of ODS is to
requirements. FDA has participated in desiring to make oral presentations strengthen knowledge and
many meetings designed to enhance should notify the contact person by May understanding of dietary supplements
harmonization, and FDA is committed 1, 2006, and submit a brief statement of by evaluating scientific information,
to seeking scientifically based the general nature of the evidence or stimulating and supporting research,
harmonized technical procedures for arguments they which to present, the disseminating research results, and
pharmaceutical development. One of names and addresses, phone number, educating the public to foster an
the goals of harmonization is to identify fax, and e-mail of proposed participants, enhanced quality of life and health for
and then reduce differences in technical and an indication of the approximate the U.S. population. To assist ODS in
requirements for medical product time requested to make their prioritizing educational and training
development among regulatory presentation. needs for researchers in the field, ODS
agencies. ICH was organized to provide The agenda for the public meeting is requesting OMB Clearance for a
an opportunity for harmonization will be made available on April 24, survey of members of academic health
initiatives to be developed with input 2006, on the Internet at http:// institutions. This effort involves a dual
from both regulatory and industry www.fda.gov/cder/meeting/ method (mail/Web) survey consisting of
representatives. ICH is concerned with ICH_20060508.htm. nine questions (including four two-part
harmonization among three regions: The
Dated: April 13, 2006. questions), which will be attempted
European Union, Japan, and the United
Jeffrey Shuren, with an estimated 2600 individuals at
States. The six ICH sponsors are the
Assistant Commissioner for Policy. approximately 1000 academic
European Commission; the European
[FR Doc. E6–5905 Filed 4–19–06; 8:45 am] institutions, yielding an annual total of
Federation of Pharmaceutical Industries
approximately 1820 respondents (based
Associations; the Japanese Ministry of BILLING CODE 4160–01–S
on a 70 percent response rate). The
Health, Labor and Welfare; the Japanese
survey results will help ODS in
Pharmaceutical Manufacturers
DEPARTMENT OF HEALTH AND measuring the scope of higher
Association; the Centers for Drug
HUMAN SERVICES education’s curriculum on dietary
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the supplements, identifying gaps in dietary
Pharmaceutical Research and National Institutes of Health supplement education, and determining
Manufacturers of America. The ICH the level of interest in potential ODS
Proposed Collection; Comment seminars and programs, and the specific
Secretariat, which coordinates the Request; ODS Assessment of Dietary
preparation of documentation, is content needs.
Supplement Education Frequency of Response: This is a one-
provided by the International
Federation of Pharmaceutical SUMMARY: The proposed information time data collection.
Manufacturers Associations (IFPMA). collection described below will be Affected Public: Academic
The ICH Steering Committee includes submitted to the Office of Management institutions.
representatives from each of the ICH and Budget (OMB) for review and Type of Respondents: Faculty
sponsors and Health Canada, the approval, as required by the Paperwork members at academic institutions.
European Free Trade Area and the Reduction Act of 1995. In compliance The annual reporting burden is as
World Health Organization. The ICH with the requirement of Section follows.

Estimated Estimated total


Estimated Average
number of annual burden
Type of respondents number of burden hours
responses per hours
respondents per response
respondent requested

Telephone or web survey completion

Individuals at academic institutions ................................................................. 1820 1 0.12 218


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Review of course information for survey completion

Individuals at academic institutions ................................................................. 1820 1 0.25 455

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