Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Allergenic Products Advisory Committee, 59832-59833 [2019-24233]
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
four of those requests becoming
effective.
The threshold of regulation process
offers one advantage over the premarket
notification process for food-contact
substances established by section 409(h)
of FD&C Act (OMB control number
0910–0495) in that the use of a
substance exempted by FDA is not
limited to only the manufacturer or
supplier who submitted the request for
an exemption. Other manufacturers or
suppliers may use exempted substances
in food-contact articles as long as the
conditions of use (e.g., use levels,
temperature, type of food contacted,
etc.) are those for which the exemption
was issued. As a result, the overall
burden on both Agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and we would not have
to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances, which is on
display at FDA’s Dockets Management
Staff and on the internet at https://
www.fda.gov/food/packaging-foodcontact-substances-fcs/thresholdregulation-exemptions-substances-usedfood-contact-articles. Having the list of
exempted substances publicly available
decreases the likelihood that a company
would submit a food additive petition or
a notification for the same type of foodcontact application of a substance for
which the Agency has previously
granted an exemption from the food
additive listing regulation requirement.
Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24230 Filed 11–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2312]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Allergenic
Products Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:43 Nov 05, 2019
Jkt 250001
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Allergenic
Products Advisory Committee (APAC)
for the Center for Biologics Evaluation
and Research notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the APAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by December 6, 2019 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by December 6,
2019.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent via email to
Prabhakara Atreya (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
must be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD
20993–0002, 240–402–8006, Fax: 301–
595–1307, email: Prabhakara.Atreya@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. Allergenic Products Advisory
Committee
The APAC reviews and evaluates data
concerning the safety, effectiveness, and
adequacy of labeling of marketed and
investigational allergenic biological
products or materials that are
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Fmt 4703
Sfmt 4703
administered to humans for the
diagnosis, prevention, or treatment of
allergies and allergic diseases, and
makes appropriate recommendations to
the Commissioner of Food and Drugs
(the Commissioner) of its findings
regarding the affirmation or revocation
of biological product licenses; on the
safety, effectiveness, and labeling of the
products; on clinical and laboratory
studies of such products; on
amendments or revisions to regulations
governing the manufacture, testing, and
licensing of allergenic biological
products; and on the quality and
relevance of FDA’s research programs
which provide the scientific support for
regulating these agents.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter via email stating that interest to
the FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
resumes. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
APAC. The interested organizations are
not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
E:\FR\FM\06NON1.SGM
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24233 Filed 11–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4763]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Assessment of
Terms and Phrases Commonly Used in
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on research entitled
‘‘Assessment of Terms and Phrases
Commonly Used in Prescription Drug
Promotion.’’
Submit either electronic or
written comments on the collection of
information by January 6, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 6,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 6, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
17:43 Nov 05, 2019
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
SUMMARY:
VerDate Sep<11>2014
Electronic Submissions
Jkt 250001
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–4763 for ‘‘Assessment of Terms
and Phrases Commonly Used in
Prescription Drug Promotion.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
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59833
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov. For copies of the
questionnaire, contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501–
3521), 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
E:\FR\FM\06NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59832-59833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2312]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Allergenic Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of a nonvoting industry representative to serve on the
Allergenic Products Advisory Committee (APAC) for the Center for
Biologics Evaluation and Research notify FDA in writing. FDA is also
requesting nominations for a nonvoting industry representative(s) to
serve on the APAC. A nominee may either be self-nominated or nominated
by an organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by December
6, 2019 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by December 6, 2019.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to
Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry representatives must be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA
advisory committee can also be obtained by visiting FDA's website at:
https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002, 240-402-8006, Fax: 301-595-1307, email:
[email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Allergenic Products Advisory Committee
The APAC reviews and evaluates data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic diseases, and makes appropriate recommendations to the
Commissioner of Food and Drugs (the Commissioner) of its findings
regarding the affirmation or revocation of biological product licenses;
on the safety, effectiveness, and labeling of the products; on clinical
and laboratory studies of such products; on amendments or revisions to
regulations governing the manufacture, testing, and licensing of
allergenic biological products; and on the quality and relevance of
FDA's research programs which provide the scientific support for
regulating these agents.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter via email stating that interest to the
FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). Within the subsequent 30
days, FDA will send a notification to each organization that has
expressed an interest, attaching a complete list of all such
organizations; and a list of all nominees along with their current
resumes. The letter will also state that it is the responsibility of
the interested organizations to confer with one another and to select a
candidate, within 60 days after the receipt of the FDA letter, to serve
as the nonvoting member to represent industry interests for the APAC.
The interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
industry interests.
III. Application Procedure
Individuals may self-nominate, and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process).
FDA seeks to include the views of women and men, members of all
racial
[[Page 59833]]
and ethnic groups, and individuals with and without disabilities on its
advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24233 Filed 11-5-19; 8:45 am]
BILLING CODE 4164-01-P
