Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, Etc.; Withdrawal of Guidance, 76015-76016 [2010-30679]
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Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices
76015
Title of Guidance
Contact
Draft Guidance for Industry—Active Controls in Studies to Demonstrate
the Effectiveness of a New Drug for Use in Companion Animals.
Lisa Troutman, Center for Veterinary Medicine (HFV–116), Food and
Drug Administration, 7500 Standish Pl., MPN–2, rm. N319, Rockville,
MD 20855, 240–276–8322, lisa.troutman@fda.hhs.gov.
Sudesh Kamath, Center for Veterinary Medicine (HFV–145), Food and
Drug Administration, 7500 Standish Pl., MPN–2, rm. E365, Rockville,
MD 20855, 240–276–8260, sudesh.kamath@fda.hhs.gov.
William Flynn, Center for Veterinary Medicine (HFV–1), Food and Drug
Administration, 7519 Standish Pl., MPN–4, rm. 173, Rockville, MD
20855, 240–276–9084, William.flynn@fda.hhs.gov.
Dennis Bensley, Center for Veterinary Medicine (HFV–140), Food and
Drug Administration, 7500 Standish Pl., MPN–2, rm. E334, Rockville,
MD 20855, 240–276–8268, dennis.bensley@fda.hhs.gov.
Mai, Huynh, Center for Veterinary Medicine, (HFV–142), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–
276–8273, Mai.huynh@fda.hhs.gov.
Emily R. Smith, (HFV–135), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–
276–8344, e-mail: emily.smith2@fda.hhs.gov.
Angela Clarke, Center for Veterinary Medicine (HFV–105), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–
276–8318; e-mail: angela.clarke@fda.hhs.gov.
Residual Solvents in Animal Drug Products; Questions and Answers ....
Draft Guidance for Industry—Updating Labeling of Certain Antimicrobial
New Animal Drug Products for Use in the Feed or Water of FoodProducing Animals.
Final Guidance for Industry—Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal
Products, VICH GL–45.
Revised Draft Guidance for Industry—Impurities: Residual Solvents In
New Veterinary Medicinal Products, Active Substances and
Excipients, VICH GL18(R).
Draft Guidance for Industry—Evaluating the Effectiveness of
Anticoccidial Drugs in Food-Producing Animals.
Draft Guidance for Industry—Protocol Submissions for the Division of
Therapeutic Drugs for Non-Food Animals the Division of Production
Drugs, and the Division of Therapeutic Drugs for Food Animals.
VIII. Office of the Commissioner
Guidance title/TOPIC
OC Contact
• Classification of products as biological products, devices, and drugs .......................................
John Weiner, Office of Combination Products,
Food and Drug Administration, 10903 New
Hampshire Ave, Silver Spring, MD 20993
301–796–8941.
Do.
• Interpretation of the term ‘‘chemical action’ in definition of device under section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
• Types of submissions for postapproval changes to combination products ................................
• Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors—FDA Inspections of Clinical Investigators
Describes FDA’s inspectional process when the agency inspects the site of an investigator
who is conducting a clinical study regulated by FDA.
• Draft Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and
Sponsors—A Guide to Informed Consent
Describes in detail basic and additional elements of informed consent and includes topics
such as review of patient records, children as subjects, and subject participation in more
than one study.
• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors—Exception
From Informed Consent Requirements for Emergency Research
This final guidance is intended to assist sponsors, clinical investigators, and IRBs in the
development, conduct, and oversight of research involving FDA-regulated products (e.g.,
drugs, biological products, devices) in emergency settings when an exception from the
informed consent requirements is requested under 21 CFR 50.24. In particular, the guidance clarifies FDA’s expectations related to planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible.
Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30623 Filed 12–6–10; 8:45 am]
emcdonald on DSK2BSOYB1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0551]
Compliance Policy Guide Sec. 393.200
Laser(s) as Medical Devices for
Facelift, Wrinkle Removal,
Acupuncture, Auricular Stimulation,
Etc.; Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
18:39 Dec 06, 2010
Jkt 223001
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Do.
Bridget Foltz, Office of Good Clinical Practices,
Food and Drug Administration, 10903 New
Hampshire Avenue, Silver Spring, MD
20993, 301–796–8348.
Sara Goldkind (301–796–8342), Marsha Melvin
(301–796–8345), Office of Good Clinical
Practices, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring,
MD 20993.
Sara Goldkind, Office of Good Clinical Practices, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 301–796–8348.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide
Sec. 393.200 Laser(s) as Medical Devices
for Facelift, Wrinkle Removal,
Acupuncture, Auricular Stimulation,
etc. (CPG Sec. 393.200). CPG Sec.
393.200 is included in FDA’s
Compliance Policy Guides Manual,
which was listed in the Annual
Comprehensive List of Guidance
Documents that published on August 9,
2010.
SUMMARY:
The withdrawal is effective
December 7, 2010.
DATES:
Notice; withdrawal.
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76016
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices
FOR FURTHER INFORMATION CONTACT:
Sean M. Boyd, Center for Devices and
Radiological Health, Office of
Communication, Education, and
Radiological Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4640, Silver Spring,
MD 20993–0002, 301–796–5895.
SUPPLEMENTARY INFORMATION: In a notice
containing a cumulative list of
guidances available from the Agency
that published in the Federal Register of
August 9, 2010 (75 FR 48180 at 48233),
FDA included the Compliance Policy
Guides Manual, which includes CPG
Sec. 393.200. FDA is withdrawing CPG
Sec. 393.200 because it is obsolete.
Dated: November 23, 2010.
Dara Corrigan,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. 2010–30679 Filed 12–6–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–P–0172 and FDA–
2010–P–0177]
Determination That AUGMENTIN ‘125’
(Amoxicillin; Clavulanate Potassium)
Chewable Tablet and Six Other
AUGMENTIN (Amoxicillin; Clavulanate
Potassium) Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the AUGMENTIN (amoxicillin;
clavulanate potassium) drug products
listed in this notice were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
SUMMARY:
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Molly Flannery, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237,
Silver Spring, MD 20993–0002, 301–
796–3543.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug. Under § 314.161(a)(2), FDA must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness whenever a listed
drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug
have been approved. Section 314.161(d)
provides that if FDA determines that a
listed drug was withdrawn from sale for
reasons of safety or effectiveness, the
Agency will initiate proceedings that
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug.
The drug products listed in table 1 of
this document are no longer being
marketed. Six of the products listed
(AUGMENTIN ‘125’ Chewable Tablet,
AUGMENTIN ‘250’ Chewable Tablet,
AUGMENTIN ‘200’ Powder for
Suspension, AUGMENTIN ‘400’ Powder
for Suspension, AUGMENTIN ‘200’
Chewable Tablet, and AUGMENTIN
‘400’ Chewable Tablet) are indicated for
the treatment of infections caused by
susceptible strains of the designated
organisms in the following conditions:
Lower respiratory tract infections,
caused by b-lactamase-producing strains
of Haemophilus influenzae and
Moraxella catarrhalis; otitis media,
caused by b-lactamase-producing strains
of H. influenzae and M. catarrhalis;
sinusitis, caused by b-lactamaseproducing strains of H. influenzae and
M. catarrhalis; skin and skin structure
infections, caused by b-lactamaseproducing strains of Staphylococcus
aureus, Escherichia coli, and Klebsiella
spp.; and urinary tract infections,
caused by b-lactamase-producing strains
of E. coli, Klebsiella spp., and
Enterobacter spp. AUGMENTIN ES–600
Powder for Suspension is indicated for
the treatment of pediatric patients with
recurrent or persistent acute otitis media
due to Streptococcus pneumoniae
(penicillin MICs ≤ 2 micrograms (mcg)/
mL), H. influenzae (including blactamase-producing strains), or M.
catarrhalis (including b-lactamaseproducing strains) characterized by the
following risk factors: antibiotic
exposure for acute otitis media within
the preceding 3 months, and either age
≤ 2 years or daycare attendance.
emcdonald on DSK2BSOYB1PROD with NOTICES
TABLE 1
Initial approval
date
Application No.
Drug
Applicant
NDA 50–597 ..................
AUGMENTIN ‘125’ (amoxicillin; clavulanate potassium) Chewable Tablet, 125 milligrams
(mg); Equivalent to (EQ) 31.25 mg base.
AUGMENTIN ‘250’ (amoxicillin; clavulanate potassium) Chewable Tablet, 250 mg; EQ 62.5
mg base.
GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101.
July 22, 1985.
Do ........................................................................
Do.
Do ..................................
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]]>Agencies
[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76015-76016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0551]
Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices
for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation,
Etc.; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide Sec. 393.200 Laser(s) as Medical
Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular
Stimulation, etc. (CPG Sec. 393.200). CPG Sec. 393.200 is included in
FDA's Compliance Policy Guides Manual, which was listed in the Annual
Comprehensive List of Guidance Documents that published on August 9,
2010.
DATES: The withdrawal is effective December 7, 2010.
[[Page 76016]]
FOR FURTHER INFORMATION CONTACT: Sean M. Boyd, Center for Devices and
Radiological Health, Office of Communication, Education, and
Radiological Programs, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4640, Silver Spring, MD 20993-0002, 301-
796-5895.
SUPPLEMENTARY INFORMATION: In a notice containing a cumulative list of
guidances available from the Agency that published in the Federal
Register of August 9, 2010 (75 FR 48180 at 48233), FDA included the
Compliance Policy Guides Manual, which includes CPG Sec. 393.200. FDA
is withdrawing CPG Sec. 393.200 because it is obsolete.
Dated: November 23, 2010.
Dara Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2010-30679 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P
