45228 Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Labeling OTC Skin 

Protectant Drug Products.’’ This 

guidance provides recommendations on 

how to label over-the-counter (OTC) 

skin protectant drug products. An OTC 

skin protectant active ingredient can be 

combined with another OTC skin 

protectant active ingredient or OTC 

external analgesic, first aid antiseptic, or 

sunscreen active ingredients. Each of 

these combinations has specific labeling 

requirements, and therefore labeling of 

OTC skin protectant drug products is 

complex. This guidance is designed to 

clarify the permitted combinations of 

active ingredients along with the 

corresponding required labeling. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by October 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michael L. Koenig, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5424, 

Silver Spring, MD 20993–0002, 301–

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Labeling OTC Skin Protectant Drug 

Products.’’ In the Federal Register of 

June 4, 2003 (68 FR 33362), FDA 

published a final rule establishing 

conditions under which OTC skin 

protectant drug products are generally 

recognized as safe and effective and not 

misbranded. In developing this final 

rule, FDA acknowledged the complex 

task that manufacturers of these 

products would face in meeting all the 

pertinent labeling requirements. This 

draft guidance provides 

recommendations on how to meet 

current labeling requirements according 

to OTC skin protectant active 

ingredient. 

Because OTC skin protectant active 

ingredients can be combined with active 

ingredients from other OTC drug 

product categories, this draft guidance is 

based upon the following rulemakings: 

(1) Final rule for OTC skin protectant 

drug products (68 FR 33362, June 4, 

2003); (2) final rule for format and 

content of labeling of OTC drugs (64 FR 

13254, March 17, 1999); (3) proposed 

rule for OTC sunscreen drug products 

(72 FR 49070, August 27, 2007); (4) 

proposed rule for OTC external 

analgesic drug products (48 FR 5852, 

February 8, 1983); and (5) proposed rule 

for OTC first aid antiseptic drug 

products (56 FR 33644, July 22, 1991). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on labeling OTC skin protectant drug 

products. 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 statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket numbers 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17835 Filed 8–1–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review: 

Comment Request; Revision of OMB 

No. 0925–0002/exp. 10/31/08, Individual 

Ruth L. Kirschstein National Research 

Service Award Applications and 

Related Forms 

SUMMARY: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995, 

the Office of the Director (OD), Office of 

Extramural Research (OER), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

March 12, 2008, Volume 73, No. 49, 

page 13242 and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: Individual 

Ruth L. Kirschstein National Research 

Service Award Applications and 

Related Forms; Type of Information 

Collection Request: Revision, OMB 

0925–0002, Expiration Date 10/31/08. 

Form Numbers: PHS 416–1, 416–9, 416–

5, 416–7, 6031, 6031–1. 

Need and Use of Information 

Collection: The 416–1 and 416–9 are 

used by individuals to apply for direct 

research training support. Awards are 

made to individual applicants for 

specified training proposals in 

biomedical and behavioral research, 

selected as a result of a national 

competition. The other related forms 

(PHS 416–5, 416–7, 6031, 6031–1) are 

used by these individuals to activate, 

terminate, and provide for payback of a 

National Research Service Award. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices 45229 

Frequency of response: Applicants may 

submit applications for published 

receipt dates. If awarded, annual 

progress is reported and trainees may be 

appointed or reappointed. Affected 

Public: Individuals or Households; 

Business or other for-profit; Not-forprofit institutions; Federal Government; 

and State, Local or Tribal Government. 

Type of Respondents: Adult scientific 

trainees and professionals. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

34,454; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours per Response: 4.1; and Estimated 

Total Annual Burden Hours Requested: 

142,301. The annualized cost to 

respondents is estimated at: $4,980,535. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time should be sent via e-mail to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Ms. 

Mikia Currie, Project Clearance Branch, 

Office of Policy for Extramural Research 

Administration, NIH, Rockledge 1 

Building, Suite 350, 6705 Rockledge 

Drive, Bethesda, MD 20892–7974, or 

call non-toll-free number (301) 435–

0941, or e-mail your request, including 

your address to: curriem@od.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: July 24, 2008. 

Pam Gilden, 

Division of Grants Policy, Office of Policy 

for Extramural Research Administration, 

Office of Extramural Research, National 

Institutes of Health. 

[FR Doc. E8–17727 Filed 8–1–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

SUPPLEMENTARY INFORMATION: 

Antibodies and Antisera Recognizing 

Members of the ArfGap Family of 

Proteins 

Description of Technology 

The technology involves antibodies 

and antisera that recognize members of 

the ArfGap protein family, including the 

following proteins: 

• ACAP1, which is related to ASAP1, 

a putative oncogene that regulates 

cancer cell invasion into normal tissues. 

ACAP1 regulates integrins, which are 

critical for cell movement associated 

with cancer cell invasion and is a target 

of the oncogene Akt. 

• ACAP2, which is related to ASAP1, 

a putative oncogene that regulates 

cancer cell invasion into normal tissues. 

• AGAP2 (also known as PIKE–A), 

ASAP1 (also called AMAP1 and DDEFl), 

and ASAP3 all exhibit elevated 

expression levels in cancer cells 

compared to non-transformed cells and 

as putative oncogenes have been 

implicated as regulators of cancer cell 

invasion into normal tissues and 

contributors to brain, eye and breast, 

and liver cancers, respectively. 

• ARAP1 (also called Centaurin Delta 

2), which has been implicated as a 

regulator of epidermal growth factor 

receptor, which plays important roles in 

several malignancies. 

• ARAP2 (also called Centaurin Delta 

1), GIT1 and GIT2; all three of which 

have been implicated as regulators of 

cell migration required for cancer cell 

invasion into normal tissues and 

metastasis. 

• ARAP3, a target of the Src 

oncogene, has been implicated as a 

regulator of cell movement and 

signaling. 

• ArfGAP1, which is critical to cell 

function, including protein trafficking. 

• ASAP2 (also known as PAG3 or as 

Pap in the 1999 Molecular and Cellular 

Biology publication), is highly related to 

ASAP1, which has been implicated as a 

regulator of cancer cell invasion into 

normal tissues. 

The table below summarizes the 

antibodies and antisera available against 

different ArfGap proteins. Each material 

has been raised or generated to the 

peptide sequence listed. 

ANTIBODIES AND ANTISERA RECOGNIZING ARFGAP PROTEINS

ArfGap member Antibody/serum ID (Alt. 

Name) 

Antibody 

source Peptide sequence (ID) HHS Ref. No. 

ACAP1 .......... 1241 (Arf6-specific GAP) ....... Rabbit ........... RPRGQPPVPPKPSIR(556) .................................................... E–244–2008/0 

ACAP2 .......... 1288 ........................................ Rabbit ........... REKGDESEKLDKKSS(365) .................................................... E–242–2008/0 

AGAP2 .......... 4569, 4571 ............................. Rabbit ........... ERVDDPELQDSI and PLSREPPPSPMVKKQ .......................

(483) .....................................................................................

E–222–2008/0 

ARAP1 .......... 1153 ........................................ Rabbit ........... SLIPLRGSENEMRRSV ........................................................... E–220–2008/0 


pwalker on PROD1PC71 with NOTICES