New Animal Drugs; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension, 52621-52622 [2010-21296]
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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Rules and Regulations
resulting overpayments. One commenter
recommended that we clarify that an
annulment ab initio will not affect the
eligibility for child’s benefits to
stepchildren prior to annulments. One
of these commenters asked us to notify
families affected by this final rule.
Response: As we stated above, we are
not adopting our proposed rules about
ab initio or prospective marriage
annulments at this time.
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of
Management and Budget (OMB) and
determined that this final rule meets the
criteria for a significant regulatory
action under Executive Order 12866.
Thus, OMB reviewed it.
Regulatory Flexibility Act
We certify that this final rule will not
have a significant economic impact on
a substantial number of small entities
because it affects only individual
persons. Therefore, the Regulatory
Flexibility Act, as amended, does not
require us to develop a regulatory
flexibility analysis.
Paperwork Reduction Act
This final rule does not impose
reporting or recordkeeping requirements
subject to OMB clearance.
(Catalog of Federal Domestic Assistance
Program Nos. 96.001 Social SecurityDisability Insurance; 96.002 Social SecurityRetirement Insurance; 96.004 Social SecuritySurvivors Insurance)
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure; Blind; Disability benefits;
Old-Age, Survivors and Disability
Insurance; Reporting and recordkeeping
requirements; Social Security.
Dated: June 7, 2010.
Michael J. Astrue,
Commissioner of Social Security.
For the reasons stated in the preamble,
we are amending 20 CFR part 404
subpart D as set forth below:
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950– )
Subpart D—[Amended]
1. The authority citation for subpart D
of part 404 continues to read as follows:
WReier-Aviles on DSKGBLS3C1PROD with RULES
■
Authority: Secs. 202, 203(a) and (b), 205(a),
216, 223, 225, 228(a)–(e), and 702(a)(5) of the
Social Security Act (42 U.S.C. 402, 403(a)
and (b), 405(a), 416, 423, 425, 428(a)–(e), and
902(a)(5)).
2. Amend § 404.352 by adding
paragraph (b)(7) to read as follows:
VerDate Mar<15>2010
14:41 Aug 26, 2010
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(b) * * *
(7) With the month in which the
divorce between your parent (including
an adoptive parent) and the insured
stepparent becomes final if you are
entitled to benefits as a stepchild and
the marriage between your parent
(including an adoptive parent) and the
insured stepparent ends in divorce.
*
*
*
*
*
■ 3. Amend § 404.363 by revising the
section heading and introductory text to
read as follows:
§ 404.363
When is a stepchild dependent?
If you are the insured’s stepchild, as
defined in § 404.357, we consider you
dependent on him or her if you were
receiving at least one-half of your
support from him or her at one of these
times—
*
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*
[FR Doc. 2010–21341 Filed 8–26–10; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor; Withdrawal of Approval of
New Animal Drug Applications;
Deslorelin Acetate; Dichlorophene and
Toluene Capsules; Pyrantel Pamoate
Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 Peptech
Animal Health Pty, Ltd. to Dechra, Ltd.
and for an abbreviated new animal drug
application (ANADA) from Church &
Dwight Co., Inc., to Pegasus
Laboratories, Inc. In addition, FDA is
removing those portions of the
regulations that reflect approval of two
other NADAs transferred from Church &
Dwight Co., Inc., to Pegasus
Laboratories, Inc., for which voluntary
withdrawal of approval was requested
after the change of sponsorship. In a
notice published elsewhere in this issue
of the Federal Register, FDA is
withdrawing approval of these two
NADAs.
SUMMARY:
■
■
§ 404.352 When does my entitlement to
child’s benefits begin and end?
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52621
This rule is effective:
1. August 27, 2010 for 21 CFR
510.600(c), 520.2043, and 522.533.
2. September 7, 2010 for 21 CFR
520.580.
DATES:
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,
e-mail: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Church &
Dwight Co., Inc., 469 North Harrison St.,
Princeton, NJ 08543–5297, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
101–497 and NADA 101–498 for oral
capsules containing dichlorophene and
toluene, and ANADA 200–028 for an
oral suspension of pyrantel pamoate to
Pegasus Laboratories, Inc., 8809 Ely Rd.,
Pensacola, FL 32514. Accordingly, the
agency is amending the regulations in
21 CFR 520.2043 to reflect the transfer
of ownership.
Peptech Animal Health Pty, Ltd., 19–
25 Khartoum Rd., Macquarie Park, New
South Wales 2113, Australia, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 141–044 for subcutaneous
implants containing deslorelin acetate
to Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-onTrent, Staffordshire, ST7 1XW, United
Kingdom. Accordingly, the agency is
amending the regulations in 21 CFR
522.533 to reflect the transfer of
ownership and a current format.
Following these changes of
sponsorship, Pegasus Laboratories, Inc.,
has requested that FDA withdraw
approval of the two NADAs for
dichlorophene and toluene capsules
because they are no longer
manufactured or marketed. In a notice
published elsewhere in this issue of the
Federal Register, FDA gave notice that
approval of NADA 101–497 and 101–
498, and all supplements and
amendments thereto, is withdrawn,
effective September 7, 2010. As
provided in the regulatory text of this
document, the agency is amending the
regulations in 21 CFR 520.580 to reflect
these withdrawals of approval.
Also, following these changes of
sponsorship, Church & Dwight Co., Inc.,
and Peptech Animal Health Pty, Ltd.,
are no longer sponsors of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to remove
the entries for these firms.
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
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52622
Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Rules and Regulations
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520 and 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 520, and 522 are
amended as follows:
■
(c) Conditions of use in horses and
ponies—(1) Amount. One implant per
mare subcutaneously in the neck.
(2) Indications for use. For inducing
ovulation within 48 hours in estrous
mares with an ovarian follicle greater
than 30 millimeters in diameter.
(3) Limitations. Do not use in horses
or ponies intended for human
consumption. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–21296 Filed 8–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
PART 510—NEW ANIMAL DRUGS
22 CFR Parts 124, 125, 126, and 129
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
[Public Notice: 7134]
RIN 1400–AC62
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Church & Dwight Co., Inc.’’ and
‘‘Peptech Animal Health Pty, Ltd.’’; and
in the table in paragraph (c)(2), remove
the entries for ‘‘010237’’ and ‘‘064288’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
[Amended].
4. In paragraph (b)(1) of § 520.580,
remove ‘‘010237,’’.
■
§ 520.2043
[Amended]
5. In paragraph (b)(2) of § 520.2043,
remove ‘‘010237’’ and in its place add
‘‘055246’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
6. The authority citation for 21 CFR
part 522 continues to read as follows:
■
WReier-Aviles on DSKGBLS3C1PROD with RULES
Authority: 21 U.S.C. 360b.
7. In § 522.533, revise the section
heading and paragraph (b), add
paragraph (c), and remove paragraph (d)
to read as follows:
■
§ 522.533
Deslorelin.
*
*
*
*
*
(b) Sponsor. See No. 043264 in
§ 510.600(c) of this chapter.
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14:41 Aug 26, 2010
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Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to remove the
requirements for prior approval or prior
notification for certain proposals to
foreign persons relating to significant
military equipment.
DATES: Effective Date: This rule is
effective August 27, 2010.
FOR FURTHER INFORMATION CONTACT:
Director Charles Shotwell, Office of
Defense Trade Controls Policy,
Department of State, Telephone (202)
663–2792 or Fax (202) 261–8199; E-mail
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change, Section 126.8.
SUPPLEMENTARY INFORMATION: In
accordance with the President’s Export
Control Reform effort, on March 29,
2010, the Department published a
Notice of Proposed Rulemaking (NPRM)
to eliminate the requirements for prior
approval or prior notification for certain
proposals to foreign persons relating to
significant military equipment at § 126.8
of the ITAR. Effective September 1,
1977, the Department of State amended
§ 123.16 to require Department of State
approval before a proposal or
presentation is made that is designed to
constitute the basis for a decision to
purchase significant combat equipment,
SUMMARY:
■
§ 520.580
Amendment to the International Traffic
in Arms Regulations: Removing
Requirement for Prior Approval for
Certain Proposals to Foreign Persons
Relating to Significant Military
Equipment
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involving the export of an item on the
U.S. Munitions List, valued at
$7,000,000 or more for use by the armed
forces of a foreign country (42 FR 41631,
dated August 18, 1977). Also, § 124.06,
entitled, ‘‘Approval of proposals for
technical assistance and manufacturing
license agreements,’’ was amended to
require similar prior approval with
respect to proposals and presentations
for technical assistance and
manufacturing license agreements
involving the production or assembly of
significant combat equipment.
‘‘Proposals to foreign persons relating
to significant military equipment’’
became § 126.8 in a final rule effective
January 1, 1985 (49 FR 47682, dated
December 6, 1984). Section 126.8 did
not require prior approval of the
Department of State when the proposed
sale was to the armed forces of a
member of the North Atlantic Treaty
Organization (NATO), Australia, Japan,
or New Zealand, except with respect to
manufacturing license agreements or
technical assistance agreements.
A prior notification requirement,
instead of prior approval, was added to
§ 126.8 in a final rule effective March
31, 1985 (50 FR 12787, dated April 1,
1985). Prior notification to the
Department of State was required 30
days in advance of a proposal or
presentation to any foreign person
where such proposals or presentations
concerned equipment previously
approved for export.
The current § 126.8 requires prior
approval or prior notification for certain
proposals and presentations to make a
determination whether to purchase
significant military equipment valued at
$14,000,000 or more (other than a
member of NATO, Australia, New
Zealand, Japan, or South Korea), or
whether to enter into a manufacturing
license agreement or technical
assistance agreement for the production
or assembly of significant military
equipment, regardless of dollar value.
These types of proposals and
presentations usually involve large
dollar amounts. Before the defense
industry undertakes the effort involved
in formulating its proposals and
presentations, if there is any doubt that
the corresponding license application or
proposed agreement would be
authorized by the Department of State,
the industry may request an advisory
opinion (see § 126.9). The written
advisory opinion, though not binding on
the Department, helps inform the
defense industry whether the
Department would likely grant a license
application or proposed agreement.
Currently, the time between submitting
a license application or proposed
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]]>Agencies
[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Rules and Regulations]
[Pages 52621-52622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21296]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor; Withdrawal of Approval of
New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and
Toluene Capsules; Pyrantel Pamoate Suspension
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 Peptech Animal Health Pty, Ltd. to Dechra, Ltd.
and for an abbreviated new animal drug application (ANADA) from Church
& Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is
removing those portions of the regulations that reflect approval of two
other NADAs transferred from Church & Dwight Co., Inc., to Pegasus
Laboratories, Inc., for which voluntary withdrawal of approval was
requested after the change of sponsorship. In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these two NADAs.
DATES: This rule is effective:
1. August 27, 2010 for 21 CFR 510.600(c), 520.2043, and 522.533.
2. September 7, 2010 for 21 CFR 520.580.
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, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Church & Dwight Co., Inc., 469 North
Harrison St., Princeton, NJ 08543-5297, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 101-497
and NADA 101-498 for oral capsules containing dichlorophene and
toluene, and ANADA 200-028 for an oral suspension of pyrantel pamoate
to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
Accordingly, the agency is amending the regulations in 21 CFR 520.2043
to reflect the transfer of ownership.
Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie
Park, New South Wales 2113, Australia, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 141-044
for subcutaneous implants containing deslorelin acetate to Dechra,
Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United Kingdom. Accordingly, the agency
is amending the regulations in 21 CFR 522.533 to reflect the transfer
of ownership and a current format.
Following these changes of sponsorship, Pegasus Laboratories, Inc.,
has requested that FDA withdraw approval of the two NADAs for
dichlorophene and toluene capsules because they are no longer
manufactured or marketed. In a notice published elsewhere in this issue
of the Federal Register, FDA gave notice that approval of NADA 101-497
and 101-498, and all supplements and amendments thereto, is withdrawn,
effective September 7, 2010. As provided in the regulatory text of this
document, the agency is amending the regulations in 21 CFR 520.580 to
reflect these withdrawals of approval.
Also, following these changes of sponsorship, Church & Dwight Co.,
Inc., and Peptech Animal Health Pty, Ltd., are no longer sponsors of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to remove the entries for these firms.
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
[[Page 52622]]
congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, and 522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Church & Dwight Co., Inc.'' and ``Peptech Animal Health
Pty, Ltd.''; and in the table in paragraph (c)(2), remove the entries
for ``010237'' and ``064288''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.580 [Amended].
0
4. In paragraph (b)(1) of Sec. 520.580, remove ``010237,''.
Sec. 520.2043 [Amended]
0
5. In paragraph (b)(2) of Sec. 520.2043, remove ``010237'' and in its
place add ``055246''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.533, revise the section heading and paragraph (b), add
paragraph (c), and remove paragraph (d) to read as follows:
Sec. 522.533 Deslorelin.
* * * * *
(b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses and ponies--(1) Amount. One implant
per mare subcutaneously in the neck.
(2) Indications for use. For inducing ovulation within 48 hours in
estrous mares with an ovarian follicle greater than 30 millimeters in
diameter.
(3) Limitations. Do not use in horses or ponies intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-21296 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S
