Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability, 49271-49272 [2013-19532]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices
Regulatory Secretariat (MVCB), 1800 F
Street NW., 2nd Floor, Washington, DC
20405–0001, telephone 202–501–4755.
ATTN: Hada Flowers/IC 3090–00xx;
MyUSA. Please cite OMB Control No.
3090–XXXX; MyUSA, in all
correspondence.
Dated: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: August 8, 2013.
Casey Coleman,
Chief Information Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–19523 Filed 8–12–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[FR Doc. 2013–19633 Filed 8–12–13; 8:45 am]
BILLING CODE 6820–34–P
[Docket No. FDA–2013–D–0880]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft Guidance for Industry on
Frequently Asked Questions About
Medical Foods; Second Edition;
Availability
AGENCY:
Food and Drug Administration
ACTION:
[Docket No. FDA–2012–N–0892]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Communicating Composite Scores in
Direct-to-Consumer Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Communicating Composite Scores in
Direct-to-Consumer (DTC) Advertising’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
On May
16, 2013, the Agency submitted a
proposed collection of information
entitled ‘‘Communicating Composite
Scores in Direct-to-Consumer (DTC)
Advertising’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0743. The
approval expires on July 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
ehiers on DSK2VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:31 Aug 12, 2013
Jkt 229001
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of the draft
guidance for industry entitled
‘‘Frequently Asked Questions About
Medical Foods; Second Edition.’’ The
draft guidance, when finalized, will
provide responses to additional
questions regarding the definition,
labeling, and availability of medical
foods and updates to some of the
existing responses.
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 the draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 15,
2013.
SUMMARY:
Submit written requests for
single copies of this draft guidance to
the Office of Nutrition, Labeling, and
Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS–
850), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Shawne Suggs-Anderson, Center for
Food Safety and Applied Nutrition
(HFS–850), Food and Drug
Administration, 5100 Paint Branch
ADDRESSES:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
49271
Pkwy., College Park, MD 20740, 240–
402–1783.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Frequently Asked Questions About
Medical Foods; Second Edition.’’ This
draft guidance is being issued consistent
with our good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
FDA’s current thinking on medical
foods. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternate approach may be used if such
approach satisfies the requirements of
the applicable statutes and regulations.
We originally issued this guidance in
May 2007. This draft guidance provides
responses to additional questions
regarding the definition, labeling, and
availability of medical foods and
updates to some of the existing
responses.
II. Paperwork Reduction Act of 1995
This 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 PRA). The
collections of information in sections
101.3, 101.4, 101.5, 101.15, and 101.105
of 21 CFR part 101 have been approved
under OMB control number 0910–0381.
The labeling provisions recommended
in this draft guidance in response to
Question 13 are not subject to review by
OMB because they do not constitute a
‘‘collection of information’’ under the
PRA. Rather, the recommended labeling
is a ‘‘public disclosure of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)).
III. Comments
Interested persons may submit either
electronic comments regarding this draft
guidance to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
E:\FR\FM\13AUN1.SGM
13AUN1
49272
Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain this draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: August 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19532 Filed 8–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ehiers on DSK2VPTVN1PROD with NOTICES
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: Pediatric
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 September 19, 2013, from 10
a.m. to 5:30 p.m. and September 20,
2013, from 8 a.m. to 1 p.m.
Location: Doubletree Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD
20910, 301–589–5200 or visit the hotel’s
Web site at https://
doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/
index.html.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301–796–
0885, email
walter.ellenberg@fda.hhs.gov or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
VerDate Mar<15>2010
15:31 Aug 12, 2013
Jkt 229001
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On September 19, 2013, and
September 20, 2013, the Pediatric
Advisory Committee (PAC) will meet to
discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the for Pediatric
Research Equity Act (Pub. L. 108–155).
On September 19, 2013, the PAC will
meet to discuss Cervarix (human
papillomavirus Bivalent (Types 16 and
18) vaccine); Gammagard Liquid
(Immune Globulin Infusion (human));
Hemacord (hematopoietic progenitor
cells, cord blood); Copegus and Pegasys
(rivabirin and peginterferon alfa-2a);
Chantix (varenicline tartrate); Isentress
(raltegravir potassium); Intuniv
(guanfacine), Topamax (topiramate);
Faslodex (fulvestrant); Ixempra Kit
(ixabepilone); and Plavix (clopidogrel
bisulfate). An update on the drug
program for KidNet will be provided.
On September 20, 2013, the PAC will
meet to discuss the Berlin Heart EXCOR
Pediatric Ventricular Assist Device;
Melody Transcatheter Pulmonary Heart
Valve (TPV); and Elana Surgical Kit
(HUD). On September 20, 2013, the
committee will also receive and discuss
a report on the September 9 and 10,
2013, meeting of the Pediatric Ethics
Subcommittee of the PAC concerning
their discussion of the ethical issues
involved in the development of
pediatric medical countermeasures.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 30, 2013.
Oral presentations from the public will
be scheduled on September 19, 2013,
between approximately 11:30 a.m. and
12 noon, and on September 20, 2013,
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
between 10:30 a.m. and 11 a.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 22, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 26, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Walter
Ellenberg at 301–796–0885, email
walter.ellenberg@fda.hhs.gov, at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 6, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–19522 Filed 8–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\13AUN1.SGM
Notice.
13AUN1
]]>Agencies
[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Pages 49271-49272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0880]
Draft Guidance for Industry on Frequently Asked Questions About
Medical Foods; Second Edition; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of the draft guidance for industry entitled ``Frequently
Asked Questions About Medical Foods; Second Edition.'' The draft
guidance, when finalized, will provide responses to additional
questions regarding the definition, labeling, and availability of
medical foods and updates to some of the existing responses.
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 the
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 15, 2013.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements,
Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Shawne Suggs-Anderson, Center for Food
Safety and Applied Nutrition (HFS-850), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1783.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Frequently Asked Questions About Medical Foods; Second
Edition.'' This draft guidance is being issued consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on medical foods. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternate approach may be used if
such approach satisfies the requirements of the applicable statutes and
regulations.
We originally issued this guidance in May 2007. This draft guidance
provides responses to additional questions regarding the definition,
labeling, and availability of medical foods and updates to some of the
existing responses.
II. Paperwork Reduction Act of 1995
This 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
PRA). The collections of information in sections 101.3, 101.4, 101.5,
101.15, and 101.105 of 21 CFR part 101 have been approved under OMB
control number 0910-0381.
The labeling provisions recommended in this draft guidance in
response to Question 13 are not subject to review by OMB because they
do not constitute a ``collection of information'' under the PRA.
Rather, the recommended labeling is a ``public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
III. Comments
Interested persons may submit either electronic comments regarding
this draft guidance to https://www.regulations.gov or written comments
to the Division of Dockets Management (see ADDRESSES). It is only
necessary to send one set of 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, and will be posted to
the docket at https://www.regulations.gov.
[[Page 49272]]
IV. Electronic Access
Persons with access to the Internet may obtain this draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: August 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19532 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P
