Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 69089 

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, 

drugs are 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was withdrawn from sale for reasons of 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withdrawn from sale for reasons of 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. 

Amphetamine sulfate, 5 mg and 10 

mg tablets, is the subject of ANDA 

083901 held by Lannett Company Inc. 

(Lannett). Amphetamine sulfate is a 

sympathomimetic amine indicated for 

treatment of narcolepsy, attention 

deficit disorder with hyperactivity, and 

exogenous obesity, as described in the 

labeling. 

In a letter dated April 4, 1994, Lannett 

notified FDA that Amphetamine sulfate, 

5 mg and 10 mg tablets, had been 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Lachman Consultant Services 

submitted a citizen petition dated June 

12, 2009 (Docket No. FDA–2009–P– 

0273), under 21 CFR 10.30, requesting 

that the Agency determine whether 

Amphetamine sulfate, 5 mg and 10 mg 

tablets, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

Amphetamine sulfate, 5 mg and 10 mg 

tablets, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that 

Amphetamine sulfate, 5 mg and 10 mg 

tablets, was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of 

Amphetamine sulfate, 5 mg and 10 mg 

tablets, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list Amphetamine sulfate, 5 

mg and 10 mg tablets, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to Amphetamine sulfate, 5 mg and 10 

mg tablets, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28358 Filed 11–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0514] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Tissue Adhesive With Adjunct Wound 

Closure Device Intended for the 

Topical Approximation of Skin; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Tissue Adhesive with 

Adjunct Wound Closure Device 

Intended for the Topical Approximation 

of Skin.’’ This guidance document 

describes a means by which tissue 

adhesives with adjunct wound closure 

devices intended for the topical 

approximation of skin may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule to classify tissue 

adhesive with adjunct wound closure 

device intended for the topical 

approximation of skin into class II 

(special controls). This guidance 

document is immediately in effect as the 

special control for tissue adhesive with 

adjunct wound closure device intended 

for approximation of skin, but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs). 

DATES: Submit either electronic or 

written comments on the guidance at 

any time. General comments on agency 

guidance are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Tissue Adhesive 

with Adjunct Wound Closure Device 

Intended for the Topical Approximation 

of Skin’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax your 

request to 301–847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

George J. Mattamal, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1434, Silver Spring, 

MD 20993–0002, 301–796–6396. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying tissue adhesive with adjunct 

wound closure device intended for the 

topical approximation of skin into class 

II (special controls), under section 

513(f)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360c(f)(2)). This guidance document 

will serve as the special control for the 

tissue adhesive with adjunct wound 

closure device intended for the topical 

approximation of skin device. Section 

513(f)(2) of the FD&C Act provides that 

any person who submits a premarket 

notification under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) for a device 

that has not previously been classified 

may, within 30 days after receiving an 

order classifying the device in class III 


emcdonald on DSK2BSOYB1PROD with NOTICES
69090 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA shall, within 60 

days of receiving such a request, classify 

the device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the agency’s current 

thinking on tissue adhesive with 

adjunct wound closure device intended 

for topical approximation of skin. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Tissue Adhesive 

with Adjunct Wound Closure Device 

Intended for the Topical Approximation 

of Skin,’’ you may either send an email 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

796–8149 to receive a hard copy. Please 

use the document number 1683 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C.3501– 

3520). The collections of information in 

21 CFR part 807, subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 58 have been 

approved under OMB control number 

0910–0119; and the collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 4, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28333 Filed 11–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel Research Centers in Trauma, Burn and 

Peri-Operative Injury. 

Date: December 3, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn By Marriott-Bethesda, 

7335 Wisconsin Avenue, Bethesda, MD 

20814. 

Contact Person: Brian R. Pike, PhD 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18, Bethesda, MD 

20892. 301–594–3907. pikbr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: November 3, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28300 Filed 11–9–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism; Initial 

Review Group; Biomedical Research Review 

Subcommittee. 

Date: March 15–16, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 


emcdonald on DSK2BSOYB1PROD with NOTICES