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Draft Guidance for Industry—Active Controls in Studies to Demonstrate 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. 

Residual Solvents in Animal Drug Products; Questions and Answers .... 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. 

Draft Guidance for Industry—Updating Labeling of Certain Antimicrobial 

New Animal Drug Products for Use in the Feed or Water of FoodProducing Animals.

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. 

Final Guidance for Industry—Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal 

Products, VICH GL–45.

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. 

Revised Draft Guidance for Industry—Impurities: Residual Solvents In 

New Veterinary Medicinal Products, Active Substances and 

Excipients, VICH GL18(R).

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. 

Draft Guidance for Industry—Evaluating the Effectiveness of 

Anticoccidial Drugs in Food-Producing Animals.

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. 

Draft Guidance for Industry—Protocol Submissions for the Division of 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.

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. 

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. 

• Interpretation of the term ‘‘chemical action’ in definition of device under section 201(h) of the 

Federal Food, Drug, and Cosmetic Act.

Do. 

• Types of submissions for postapproval changes to combination products ................................ Do. 

• 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.

Bridget Foltz, Office of Good Clinical Practices, 

Food and Drug Administration, 10903 New 

Hampshire Avenue, Silver Spring, MD 

20993, 301–796–8348. 

• 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.

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. 

• 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.

Sara Goldkind, Office of Good Clinical Practices, Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–8348. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30623 Filed 12–6–10; 8:45 am] 

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: 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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
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. 

SUMMARY: 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 

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. 

TABLE 1 

Application No. Drug Applicant Initial approval 

date 

NDA 50–597 .................. AUGMENTIN ‘125’ (amoxicillin; clavulanate potassium) Chewable Tablet, 125 milligrams 

(mg); Equivalent to (EQ) 31.25 mg base.

GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101.July 22, 1985. 

Do .................................. AUGMENTIN ‘250’ (amoxicillin; clavulanate potassium) Chewable Tablet, 250 mg; EQ 62.5 

mg base.

Do ........................................................................ Do. 


emcdonald on DSK2BSOYB1PROD with NOTICES