Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications; Opportunity for a Hearing, 66748-66750 [2013-26491]
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Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
through written comments that can be
submitted to the public docket (see
ADDRESSES). When submitting
comments to the docket, please provide
some context to your comment by
indicating whether you are an
adolescent or young adult, or older
adult. If you are commenting on behalf
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sickle cell disease, please indicate that
and answer the following questions as
much as possible from the patient’s
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mstockstill on DSK4VPTVN1PROD with NOTICES
Topic 1: The Effects of Sickle Cell
Disease That Matter Most to You
1. Of all of the ways that sickle cell
disease affects your health, which one to
three effects have the greatest impact on
your life? (Examples may include pain
crises, breathing problems, difficulty
concentrating, tiredness, infections, and
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2. How does sickle cell disease affect
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(Examples may include sleeping
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3. How does sickle cell disease affect
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Topic 2: Perspectives on Treatments for
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1. Are you currently using any
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b. What are the biggest problems with
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2. Besides prescription medications,
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therapies.
a. What specific parts of your sickle
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c. What are the biggest problems with
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3. What parts of your sickle cell
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4. Assuming that there is no cure for
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would you look for in an ideal
treatment?
5. If you had the opportunity to
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studying experimental treatments for
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you consider when deciding whether or
not to participate? Examples may
include how severe your sickle cell
disease is, how well current treatments
are working for you, your concern about
serious risks, and other things.
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[Docket No. FDA–2013–N–1285]
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FOR FURTHER INFORMATION CONTACT)
Dated: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26548 Filed 11–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Smith Miller and Patch Inc. et al.;
Proposal to Withdraw Approval of 14
New Drug Applications; Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity to request a hearing on the
Agency’s proposal to withdraw approval
of 14 new drug applications (NDAs)
from multiple sponsors. The basis for
the proposal is that the sponsors have
repeatedly failed to file required annual
reports for these applications.
DATES: Submit written requests for a
hearing by December 6, 2013; submit
data and information in support of the
hearing request by January 6, 2014.
ADDRESSES: Identify your requests for a
hearing, supporting data, and other
comments with Docket No. FDA–2013–
N–1285, and submit this information to
the Division of Dockets Management
(HFA–305), Food and Drug
SUMMARY:
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Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
66749
applications in accordance with
§ 314.81 (21 CFR 314.81). The holders of
the approved applications listed in table
1 have failed to submit the required
annual reports and have not responded
to the Agency’s request by certified mail
for submission of the reports.
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN MADE
Drug
Applicant
NDA 004979 ........................
Multi-Vitamin Tablets .......................................................
NDA 008176 ........................
NDA 008326 ........................
NDA 008362 ........................
Methostan (methandriol) Tablets ....................................
Methischol (inositol/vitamin B12/racemethionine/choline
chloride) Injection.
Corticotropin Injection .....................................................
NDA 009346 ........................
NDA 009515 ........................
ACTH (corticotropin) Injection .........................................
Hyrye (riboflavin 5’-phosphate sodium) Injection ............
NDA 010415 ........................
Flamotide (riboflavin 5’-phosphate sodium) Injection .....
NDA 010565 ........................
Duracton (corticotropin) Injection ....................................
NDA 010791 ........................
Rubivite (cyanocobalamin) Injection ...............................
NDA 010831 ........................
Corticotropin Injection .....................................................
NDA 011015 ........................
RU–B–12–1000 (cyanocobalamin) Injection ...................
NDA 011578 ........................
Efacin (niacin) Tablet ......................................................
NDA 017861 ........................
Acthar Gel Synthetic (seractide acetate) Injection .........
NDA 018087 ........................
mstockstill on DSK4VPTVN1PROD with NOTICES
Application No.
Thyrel TRH (protirelin) Injection ......................................
Smith Miller and Patch Inc., P.O. Box 367, San German, PR 00753.
Do.
USV Pharmaceutical Corp., 500 Virginia Dr., Fort
Washington, PA 19034–2779.
Vitarine Pharmaceuticals Inc., 227–15 North Conduit
Ave., Springfield Gardens, NY 11413.
Parke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
S.F. Durst and Co., Inc., 5317–21 North Third St.,
Philadelphia, PA 19120.
Philadelphia Ampoule Laboratories, 400 Green St.,
Philadelphia, PA 19123.
Nordic Biochemicals Inc., 45 Bay State Rd., Boston,
MA 02215.
Bel Mar Laboratories, Inc., 6–10 Nassau Ave., Inwood,
NY 11696.
Organics/LaGrange, Inc., 1935 Techny Rd., Suite 14,
Northbrook, IL 60062.
Dow Pharmaceutical Corp., 9550 North Zionsville Rd.,
Indianapolis, IN 46268.
Person and Covey, Inc., 616 Allen Ave., Glendale, CA
91201.
Armour Pharmaceutical Co., P.O. Box 511, Kankakee,
IL 60901.
Ferring Pharmaceuticals, Inc., 400 Rella Blvd., Suite
300, Suffern, NY 10901.
Therefore, notice is given to the
holders of the approved applications
listed in table 1 and to all other
interested persons that the Director of
the Center for Drug Evaluation and
Research proposes to issue an order
under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(e)) withdrawing
approval of the applications and all
amendments and supplements thereto
on the ground that the applicants have
failed to submit reports required under
§ 314.81.
In accordance with section 505 of the
FD&C Act and part 314 (21 CFR part
314), the applicants are hereby provided
an opportunity for a hearing to show
why the applications listed previously
should not be withdrawn and an
opportunity to raise, for administrative
determination, all issues relating to the
legal status of the drug products covered
by these applications.
An applicant who decides to seek a
hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES) and (2)
the data, information, and analyses
relied on to demonstrate that there is a
genuine and substantial issue of fact
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that requires a hearing (see DATES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
notice of participation and request for a
hearing, information and analyses to
justify a hearing, other comments, and
a grant or denial of a hearing are
contained in § 314.200 and in 21 CFR
part 12.
The failure of an applicant to file a
timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
applicant not to avail itself of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and constitutes a waiver of
any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the
applications and the drug products may
not thereafter lawfully be marketed, and
FDA will begin appropriate regulatory
action to remove the products from the
market. Any new drug product
marketed without an approved new
drug application is subject to regulatory
action at any time.
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A request for a hearing may not rest
upon mere allegations or denials, but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. Reports
submitted to remedy the deficiencies
must be complete in all respects in
accordance with § 314.81. If the
submission is not complete or if a
request for a hearing is not made in the
required format or with the required
reports, the Commissioner of Food and
Drugs will enter summary judgment
against the person who requests the
hearing, making findings and
conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen in the Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday, and will be posted to the docket
at https://www.regulations.gov.
This notice is issued under the
Federal Food, Drug, and Cosmetic Act
(section 505 (21 U.S.C. 355)) and under
authority delegated to the Director,
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66750
Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs.
Dated: October 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–26491 Filed 11–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Customer and Other Partners
Satisfaction Surveys
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for the opportunity for public comment
on the proposed data collection projects,
the National Institutes of Health Clinical
Center (CC) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Whether the proposed collection
minimizes the burden of the collection
of information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. David K.
Henderson, Deputy Director for Clinical
Care, National Institutes of Health
Clinical Center, 10 Center Drive, Bldg.
10, Rm. 6–1480, Bethesda, MD 20892 or
call non-toll-free number (301) 496–
3515 or email your request, including
your address to: dkh@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Title: Generic
Clearance for Surveys of Customers and
Other Partners, 0925–0458, Expiration
Date 12/31/2013, Type of Submission:
Extension, National Institutes of Health
Clinical Center (CC), National Institutes
of Health (NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by Clinical
Center personnel: (1) To evaluate the
perceptions of various Clinical Center
customers and other partners of Clinical
Center services; (2) to assist with the
design of modifications of these
services, based on customer input; (3) to
develop new services, based on
customer need; (4) to evaluate the
perceptions of various Clinical Center
customers and other partners of
implemented service modifications, and
(5) for hospital accreditation. These
surveys are voluntary and necessary for
the proper performance of Clinical
Center functions and will almost
certainly lead to quality improvement
activities that will enhance and/or
streamline the Clinical Center’s
operations. The major mechanisms by
which the Clinical Center will request
customer input is through surveys and
focus groups. The surveys will be
tailored specifically to each class of
customer and to that class of customer’s
needs. Surveys will either be collected
as written documents, as faxed
documents, mailed electronically or
collected via the web or by telephone
from customers. Information gathered
from these surveys of Clinical Center
customers and other partners will be
presented to, and used directly by,
Clinical Center management to enhance
the services and operations of our
organization.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4,900.
FY 2014
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
5000
2000
500
2000
500
2000
30
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
2500
1000
84
334
167
667
10
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FY 2015
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]]>Agencies
[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66748-66750]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26491]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1285]
Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval
of 14 New Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity to request a hearing on the Agency's proposal to withdraw
approval of 14 new drug applications (NDAs) from multiple sponsors. The
basis for the proposal is that the sponsors have repeatedly failed to
file required annual reports for these applications.
DATES: Submit written requests for a hearing by December 6, 2013;
submit data and information in support of the hearing request by
January 6, 2014.
ADDRESSES: Identify your requests for a hearing, supporting data, and
other comments with Docket No. FDA-2013-N-1285, and submit this
information to the Division of Dockets Management (HFA-305), Food and
Drug
[[Page 66749]]
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec. 314.81 (21 CFR 314.81). The holders of the approved applications
listed in table 1 have failed to submit the required annual reports and
have not responded to the Agency's request by certified mail for
submission of the reports.
Table 1--Approved NDAs for Which Required Reports Have Not Been Made
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 004979.................. Multi-Vitamin Smith Miller and
Tablets. Patch Inc., P.O.
Box 367, San
German, PR 00753.
NDA 008176.................. Methostan Do.
(methandriol)
Tablets.
NDA 008326.................. Methischol (inositol/ USV Pharmaceutical
vitamin B12/ Corp., 500 Virginia
racemethionine/ Dr., Fort
choline chloride) Washington, PA
Injection. 19034-2779.
NDA 008362.................. Corticotropin Vitarine
Injection. Pharmaceuticals
Inc., 227-15 North
Conduit Ave.,
Springfield
Gardens, NY 11413.
NDA 009346.................. ACTH (corticotropin) Parke-Davis, 201
Injection. Tabor Rd., Morris
Plains, NJ 07950.
NDA 009515.................. Hyrye (riboflavin 5'- S.F. Durst and Co.,
phosphate sodium) Inc., 5317-21 North
Injection. Third St.,
Philadelphia, PA
19120.
NDA 010415.................. Flamotide Philadelphia Ampoule
(riboflavin 5'- Laboratories, 400
phosphate sodium) Green St.,
Injection. Philadelphia, PA
19123.
NDA 010565.................. Duracton Nordic Biochemicals
(corticotropin) Inc., 45 Bay State
Injection. Rd., Boston, MA
02215.
NDA 010791.................. Rubivite Bel Mar
(cyanocobalamin) Laboratories, Inc.,
Injection. 6-10 Nassau Ave.,
Inwood, NY 11696.
NDA 010831.................. Corticotropin Organics/LaGrange,
Injection. Inc., 1935 Techny
Rd., Suite 14,
Northbrook, IL
60062.
NDA 011015.................. RU-B-12-1000 Dow Pharmaceutical
(cyanocobalamin) Corp., 9550 North
Injection. Zionsville Rd.,
Indianapolis, IN
46268.
NDA 011578.................. Efacin (niacin) Person and Covey,
Tablet. Inc., 616 Allen
Ave., Glendale, CA
91201.
NDA 017861.................. Acthar Gel Synthetic Armour
(seractide acetate) Pharmaceutical Co.,
Injection. P.O. Box 511,
Kankakee, IL 60901.
NDA 018087.................. Thyrel TRH Ferring
(protirelin) Pharmaceuticals,
Injection. Inc., 400 Rella
Blvd., Suite 300,
Suffern, NY 10901.
------------------------------------------------------------------------
Therefore, notice is given to the holders of the approved
applications listed in table 1 and to all other interested persons that
the Director of the Center for Drug Evaluation and Research proposes to
issue an order under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of the
applications and all amendments and supplements thereto on the ground
that the applicants have failed to submit reports required under Sec.
314.81.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the applicants are hereby provided an opportunity for a
hearing to show why the applications listed previously should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
products covered by these applications.
An applicant who decides to seek a hearing must file the following:
(1) A written notice of participation and request for a hearing (see
DATES) and (2) the data, information, and analyses relied on to
demonstrate that there is a genuine and substantial issue of fact that
requires a hearing (see DATES). Any other interested person may also
submit comments on this notice. The procedures and requirements
governing this notice of opportunity for a hearing, notice of
participation and request for a hearing, information and analyses to
justify a hearing, other comments, and a grant or denial of a hearing
are contained in Sec. 314.200 and in 21 CFR part 12.
The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the applications and the drug products may not
thereafter lawfully be marketed, and FDA will begin appropriate
regulatory action to remove the products from the market. Any new drug
product marketed without an approved new drug application is subject to
regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. Reports
submitted to remedy the deficiencies must be complete in all respects
in accordance with Sec. 314.81. If the submission is not complete or
if a request for a hearing is not made in the required format or with
the required reports, the Commissioner of Food and Drugs will enter
summary judgment against the person who requests the hearing, making
findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at https://www.regulations.gov.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (section 505 (21 U.S.C. 355)) and under authority delegated to the
Director,
[[Page 66750]]
Center for Drug Evaluation and Research, by the Commissioner of Food
and Drugs.
Dated: October 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-26491 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P
