New Drug Applications and Abbreviated New Drug Applications; Technical Amendment, 9765-9766 [E9-4813]
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Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
4. Section 347.20 is amended by
redesignating paragraphs (b), (c), and (d)
as paragraphs (c), (d), and (e),
respectively, and by adding new
paragraph (b) to read as follows:
■
§ 347.20 Permitted combinations of active
ingredients.
*
*
*
*
*
(b) Combination of ingredients to
prepare an aluminum acetate solution.
Aluminum sulfate tetradecahydrate may
be combined with calcium acetate
monohydrate in powder or tablet form
to provide a 0.13 to 0.5 percent
aluminum acetate solution when the
powder or tablet is dissolved in the
volume of water specified in
‘‘Directions.’’
*
*
*
*
*
■ 5. Section 347.52 is amended by
revising paragraph (a) and (b)(1)
paragraph heading, and by revising
paragraphs (c) and (d)(1), and by adding
new paragraph (d)(4) to read as follows:
mstockstill on PROD1PC66 with RULES
§ 347.52 Labeling of astringent drug
products.
(a) Statement of identity. The labeling
of the product contains the established
name of the drug, if any, and identifies
the product as an ‘‘astringent.’’ For
products containing the combination of
aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified
in § 347.20(b), under the ‘‘Purpose’’
heading identified in § 201.66(c)(3) of
this chapter, the labeling of each active
ingredient in the product states
‘‘Astringent*’’, which is followed by the
statements ‘‘* When combined together
in water, these ingredients form the
active ingredient aluminum acetate. See
[the following in bold italic type]
Directions.’’
(b) Indications. * * *
(1) For products containing aluminum
acetate identified in § 347.12(a) or the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
monohydrate identified in § 347.20(b).
* * *
*
*
*
*
*
(c) Warnings. The labeling of the
product contains the following warnings
under the heading ‘‘Warnings’’:
(1) For all products—(i) The labeling
states ‘‘For external use only’’.
(ii) The labeling states ‘‘When using
this product [bullet] avoid contact with
eyes. If contact occurs, rinse thoroughly
with water.’’
(2) For products containing aluminum
acetate identified in § 347.12(a), witch
hazel identified in § 347.12(c), or the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
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16:15 Mar 05, 2009
Jkt 217001
monohydrate identified in § 347.20(b).
The labeling states ‘‘Stop use and ask a
doctor if [bullet] condition worsens or
symptoms last more than 7 days’’.
(3) For products containing aluminum
acetate identified in § 347.12(a) or the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
monohydrate identified in § 347.20(b)
when labeled for use as a compress or
wet dressing. The labeling states ‘‘When
using this product [bullet] do not cover
compress or wet dressing with plastic to
prevent evaporation’’.
(4) For products containing aluminum
acetate identified in § 347.12(a) or the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
monohydrate identified in § 347.20(b)
when labeled for use as a soak,
compress, or wet dressing. The labeling
states ‘‘When using this product [bullet]
in some skin conditions, soaking too
long may overdry’’.
(d) Directions. * * *
(1) For products containing aluminum
acetate identified in § 347.12(a) or the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
monohydrate identified in § 347.20(b)—
(i) For products used as a soak. ‘‘For use
as a soak: [preceding words in bold
type] [bullet] soak affected area for 15 to
30 minutes as needed, or as directed by
a doctor [bullet] repeat 3 times a day or
as directed by a doctor [bullet] discard
solution after each use’’ .
(ii) For products used as a compress
or wet dressing. ‘‘For use as a compress
or wet dressing: [preceding words in
bold type] [bullet] soak a clean, soft
cloth in the solution [bullet] apply cloth
loosely to affected area for 15 to 30
minutes [bullet] repeat as needed or as
directed by a doctor [bullet] discard
solution after each use’’.
*
*
*
*
*
(4) For products containing the
combination of aluminum sulfate
tetradecahydrate and calcium acetate
monohydrate identified in § 347.20(b)—
(i) For powder dosage form. The labeling
states ‘‘[bullet] dissolve 1 to 3 packets in
[insert volume] of cool or warm water
[bullet] stir until fully dissolved; do not
strain or filter. The resulting mixture
contains [insert percent] (1 packet),
[insert percent] (2 packets), or [insert
percent] (3 packets) aluminum acetate
and is ready for use.’’ These statements
shall be the first statements under the
heading ‘‘Directions’’.
(ii) For tablet dosage form. The
labeling states ‘‘[bullet] dissolve 1 to 3
tablets in [insert volume] of cool or
warm water [bullet] stir until fully
dissolved; do not strain or filter. The
resulting mixture contains [insert
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9765
percent] (1 tablet), [insert percent] (2
tablets), or [insert percent] (3 tablets)
aluminum acetate and is ready for use.’’
These statements shall be the first
statements under the heading
‘‘Directions’’.
*
*
*
*
*
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4746 Filed 3–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 314
[Docket No. FDA–2009–N–0099]
New Drug Applications and
Abbreviated New Drug Applications;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
new drug application (NDA) and
abbreviated new drug application
(ANDA) regulations to update agency
contacts for patent information and
patent notifications and to correct an
inaccurate cross-reference. This action
is being taken to ensure accuracy and
clarity in the agency’s regulations.
DATES: This rule is effective March 6,
2009.
FOR FURTHER INFORMATION CONTACT:
Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 51, rm.
6308, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 301–
796–3506.
SUPPLEMENTARY INFORMATION: FDA is
amending its NDA and ANDA
regulations in part 314 (21 CFR part
314) to update agency contacts for
information and notifications pertaining
to patents and to correct an inaccurate
reference. To accommodate the ongoing
relocation of FDA offices, users are
directed to FDA’s Web site to obtain the
current address of the Office of Generic
Drugs.
In §§ 314.52(a)(2) and 314.95(a)(2),
FDA is updating the agency contact for
obtaining the name and address of the
NDA holder or designee for purposes of
providing notice of a patent certification
submitted under section 505(b)(2)(A)(iv)
E:\FR\FM\06MRR1.SGM
06MRR1
9766
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations
or 505(j)(2)(A)(vii)(IV) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(b)(2)(A)(iv) or
355(j)(2)(A)(vii)(IV)). The Division of
Drug Information Resources no longer
exists. The agency contact for this
information is now the Orange Book
Staff, Office of Generic Drugs.
In § 314.53(f), FDA is updating the
agency unit to which notifications of
requests for correction of patent
information should be directed. The
Drug Information Services Branch no
longer exists. These notifications should
now be sent to the Office of Generic
Drugs Document Room, attention the
Orange Book Staff.
In § 314.107(e), FDA is updating the
listing of agency units to which a
505(b)(2) applicant must send
notification of entry of an order or
judgment in a court action. Instead of
the appropriate division in the Office of
Drug Evaluation I and Office of Drug
Evaluation II, these notifications should
now be sent to the appropriate division
in the Office of New Drugs.
In § 314.107(f)(2)(iv), FDA is updating
the agency recipient of a 505(b)(2)
applicant’s required notification that a
legal action has been filed within 45
days of receipt of a notice of paragraph
IV certification (submitted under section
505(b)(2)(A)(iv) of the act) from the
appropriate division in the Center for
Drug Evaluation and Research to the
appropriate division in the Office of
New Drugs.
In § 314.125(b)(16), FDA is correcting
a cross-reference to the agency’s
regulations on institutional review
boards (21 CFR part 56) by replacing
‘‘part 58’’ with ‘‘part 56.’’
Publication of this document
constitutes final action under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because the amendments to the
regulations provide only technical
changes to correct an inaccurate citation
and to update agency contacts, and are
nonsubstantive.
mstockstill on PROD1PC66 with RULES
List of Subjects in 21 CFR Part 314
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 314 is
amended as follows:
■
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16:15 Mar 05, 2009
Jkt 217001
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
1. The authority citation for 21 CFR
part 314 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 356a, 356b, 356c, 371, 374,
379e.
§ 314.52
[Amended]
Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E9–4813 Filed 3–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
2. Section 314.52 is amended in
paragraph (a)(2) by removing ‘‘Division
of Drug Information Resources (HFD–
80), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Orange Book Staff, Office of
Generic Drugs, at the address identified
on FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.53
[Amended]
3. Section 314.53 is amended in
paragraph (f) by removing ‘‘Drug
Information Services Branch (HFD–84),
Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Office of Generic Drugs, OGD
Document Room, Attention: Orange
Book Staff, at the address identified on
FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.95
[Amended]
4. Section 314.95 is amended in
paragraph (a)(2) by removing ‘‘Division
of Drug Information Resources (HFD–
80), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Orange Book Staff, Office of
Generic Drugs, at the address identified
on FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.107
[Amended]
5. Section 314.107 is amended in
paragraph (e) by removing ‘‘Office of
Drug Evaluation I (HFD–100) or Office
of Drug Evaluation II (HFD–500),
whichever is applicable,’’ and by adding
in its place ‘‘Office of New Drugs’’ and
in paragraph (f)(2)(iv) by removing
‘‘Center for Drug Evaluation and
Research’’ and by adding in its place
‘‘Office of New Drugs’’.
■
§ 314.125
[Amended]
6. Section 314.125 is amended in
paragraph (b)(16) by removing ‘‘part 58’’
and by adding in its place ‘‘part 56’’.
■
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21 CFR Parts 510 and 529
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Change of
Sponsor; Methoxyflurane
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for a new animal drug
application (NADA) from ScheringPlough Animal Health, Inc., to Medical
Developments International, Ltd.
DATES:
This rule is effective March 6,
2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
14–485 for ANAFANE (methoxyflurane)
Volatile Liquid for Inhalation
Anesthesia to Medical Developments
International, Ltd., P.O. Box 21,
Sandown Village, 3171 VIC Australia.
Medical Developments International,
Ltd., is not currently listed in the animal
drug regulations as a sponsor of an
approved application. In addition, FDA
has noticed that this new animal drug
has not been previously codified in 21
CFR part 529. Accordingly, the
regulations are amended in 21 CFR
510.600(c) to add entries for Medical
Developments International, Ltd., and in
21 CFR part 529 to add this new animal
drug.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06MRR1.SGM
06MRR1
]]>Agencies
[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Rules and Regulations]
[Pages 9765-9766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 314
[Docket No. FDA-2009-N-0099]
New Drug Applications and Abbreviated New Drug Applications;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its new
drug application (NDA) and abbreviated new drug application (ANDA)
regulations to update agency contacts for patent information and patent
notifications and to correct an inaccurate cross-reference. This action
is being taken to ensure accuracy and clarity in the agency's
regulations.
DATES: This rule is effective March 6, 2009.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, rm.
6308, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3506.
SUPPLEMENTARY INFORMATION: FDA is amending its NDA and ANDA regulations
in part 314 (21 CFR part 314) to update agency contacts for information
and notifications pertaining to patents and to correct an inaccurate
reference. To accommodate the ongoing relocation of FDA offices, users
are directed to FDA's Web site to obtain the current address of the
Office of Generic Drugs.
In Sec. Sec. 314.52(a)(2) and 314.95(a)(2), FDA is updating the
agency contact for obtaining the name and address of the NDA holder or
designee for purposes of providing notice of a patent certification
submitted under section 505(b)(2)(A)(iv)
[[Page 9766]]
or 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV)). The
Division of Drug Information Resources no longer exists. The agency
contact for this information is now the Orange Book Staff, Office of
Generic Drugs.
In Sec. 314.53(f), FDA is updating the agency unit to which
notifications of requests for correction of patent information should
be directed. The Drug Information Services Branch no longer exists.
These notifications should now be sent to the Office of Generic Drugs
Document Room, attention the Orange Book Staff.
In Sec. 314.107(e), FDA is updating the listing of agency units to
which a 505(b)(2) applicant must send notification of entry of an order
or judgment in a court action. Instead of the appropriate division in
the Office of Drug Evaluation I and Office of Drug Evaluation II, these
notifications should now be sent to the appropriate division in the
Office of New Drugs.
In Sec. 314.107(f)(2)(iv), FDA is updating the agency recipient of
a 505(b)(2) applicant's required notification that a legal action has
been filed within 45 days of receipt of a notice of paragraph IV
certification (submitted under section 505(b)(2)(A)(iv) of the act)
from the appropriate division in the Center for Drug Evaluation and
Research to the appropriate division in the Office of New Drugs.
In Sec. 314.125(b)(16), FDA is correcting a cross-reference to the
agency's regulations on institutional review boards (21 CFR part 56) by
replacing ``part 58'' with ``part 56.''
Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because the amendments to the
regulations provide only technical changes to correct an inaccurate
citation and to update agency contacts, and are nonsubstantive.
List of Subjects in 21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
314 is amended as follows:
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
0
1. The authority citation for 21 CFR part 314 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 371, 374, 379e.
Sec. 314.52 [Amended]
0
2. Section 314.52 is amended in paragraph (a)(2) by removing ``Division
of Drug Information Resources (HFD-80), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857'' and by adding in its place ``Orange Book Staff, Office of
Generic Drugs, at the address identified on FDA's Web site (https://
www.fda.gov/cder/ogd)''.
Sec. 314.53 [Amended]
0
3. Section 314.53 is amended in paragraph (f) by removing ``Drug
Information Services Branch (HFD-84), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857'' and by adding in its place ``Office of Generic Drugs, OGD
Document Room, Attention: Orange Book Staff, at the address identified
on FDA's Web site (https://www.fda.gov/cder/ogd)''.
Sec. 314.95 [Amended]
0
4. Section 314.95 is amended in paragraph (a)(2) by removing ``Division
of Drug Information Resources (HFD-80), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857'' and by adding in its place ``Orange Book Staff, Office of
Generic Drugs, at the address identified on FDA's Web site (https://
www.fda.gov/cder/ogd)''.
Sec. 314.107 [Amended]
0
5. Section 314.107 is amended in paragraph (e) by removing ``Office of
Drug Evaluation I (HFD-100) or Office of Drug Evaluation II (HFD-500),
whichever is applicable,'' and by adding in its place ``Office of New
Drugs'' and in paragraph (f)(2)(iv) by removing ``Center for Drug
Evaluation and Research'' and by adding in its place ``Office of New
Drugs''.
Sec. 314.125 [Amended]
0
6. Section 314.125 is amended in paragraph (b)(16) by removing ``part
58'' and by adding in its place ``part 56''.
Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E9-4813 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S
