864 Federal Register / Vol. 73, No. 3 / Friday, January 4, 2008 / Notices 

The full text of document DA 07–4924 

and copies of any subsequently filed 

documents in this matter will be 

available for public inspection and 

copying during regular business hours 

at the FCC Reference Information 

Center, Portals II, 445 12th Street, SW., 

Room CY–A257, Washington, DC 20554. 

Document DA 07–4924 and copies of 

subsequently filed documents in this 

matter may also be purchased from the 

Commission’s duplicating contractor at 

Portals II, 445 12th Street, SW., Room 

CY–B402, Washington, DC 20554; the 

contractor’s Web site, http:// 

www.bcpiweb.com; or by calling (800) 

378–3160. Document DA 07–4924 and 

subsequently filed documents in this 

matter may also be found by searching 

ECFS at http://www.fcc.gov/cgb/ecfs 

(insert CG Docket No. 03–123 into the 

Proceeding block). 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an e-mail to 

fcc504@fcc.gov or call the Consumer & 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). Document DA 07–4924 can also 

be downloaded in Word or Portable 

Document Format (PDF) at: http:// 

www.fcc.gov/cgb/dro/trs.html. 

Synopsis 

On May 18, 2007, Hawk filed its 

DBRS Petition for clarification 

proposing DBRS as a form of TRS 

compensable from the Interstate TRS 

Fund. As described by Hawk, its 

proposed DBRS would use an 

interpreter (a ‘‘Communications 

Facilitator’’ (CF)) to sit with the deaf/ 

blind user, place or receive 

conventional voice-to-voice telephone 

calls on his or her behalf, and interpret 

the ensuing conversation(s). The CF 

would travel to the DBRS consumer’s 

location to assist in placing the call. 

Alternatively, a DBRS consumer could 

travel to a regional DBRS center to place 

a call through a CF. 

The Bureau seeks comment on the 

DBRS Petition, including, specifically, 

whether DBRS falls within the 

definition of TRS as set forth in section 

225(a)(3) of the Communications Act of 

1934, 47 U.S.C. 225(a)(3). The Bureau 

notes, for example, that Hawk’s 

proposed DBRS does not fit within the 

typical two-leg relay paradigm in which 

a relay center receives and places 

inbound and outbound calls between 

the end users to the relay call. Instead, 

the DBRS would employ a CF to assist 

the caller, in person, in making a 

telephone call. 

Federal Communications Commission. 

Nicole McGinnis, 

Deputy Chief, Consumer & Governmental 

Affairs Bureau. 

[FR Doc. E7–25648 Filed 1–3–08; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Meeting 

ACTION: Amendment of Meeting 

Announcement, dated December 26, 

2007. 

SUMMARY: This notice amends the 

meeting date for the 19th meeting of the 

American Health Information 

Community in accordance with the 

Federal Advisory Committee Act (Pub. 

L. No. 92–463, 5 U.S.C., App.) The 

American Health Information 

Community will advise the Secretary 

and recommend specific actions to 

achieve a common interoperability 

framework for health information 

technology (IT). 

Revised Meeting Date: January 22, 

2008, from 8:30 to 12:00 p.m. 

(previously scheduled on January 15, 

2008). 

ADDRESSES: Hubert H. Humphrey 

building (200 Independence Avenue, 

SW., Washington, DC 20201), 

Conference Room 800. 

SUPPLEMENTARY INFORMATION: The 

meeting will include presentations by 

the Population Health/Clinical Care 

Connections Workgroup and Electronic 

Health Records Workgroup on 

Recommendations to the Community; 

an update on the Health IT Physician 

Adoption Survey results; an update on 

the Healthcare Information Technology 

Standards Panel (HITSP) 

Interoperability Specifications; and an 

update on the findings from the 

Enhancing Data Quality in EHRs Report. 

For further information, visit http:// 

www.hhs.gov/healthit/ahic.html. A Web 

cast of the Community meeting will be 

available on the NIH Web site at: 

http://www.videocast.nih.gov/. 

If you have special needs for the 

meeting, please contact (202) 690–7151. 

Dated: December 27, 2007. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 07–6281 Filed 1–3–08; 8:45 am] 

BILLING CODE 4150–45–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Meeting: Secretary’s 

Advisory Committee on Genetics, 

Health, and Society 

Pursuant to Public Law 92–463, 

notice is hereby given of the fifteenth 

meeting of the Secretary’s Advisory 

Committee on Genetics, Health, and 

Society (SACGHS), U.S. Public Health 

Service. The meeting will be held from 

8:30 a.m. to approximately 5:30 p.m. on 

Tuesday, February 12, 2008 and 8 a.m. 

to approximately 5 p.m. on Wednesday, 

February 13, 2008, at the Hubert H. 

Humphrey Building—200 Independence 

Avenue, SW., Washington, DC 20201. 

The meeting will be open to the public 

with attendance limited to space 

available. The meeting also will be Web 

cast. 

The main agenda item will involve 

deliberations on the oversight of genetic 

testing, including an overview of public 

comments received on the Committee’s 

draft report U.S. System of Oversight of 

Genetic Testing: A Response to the 

Charge of the Secretary of HHS and the 

formulation of final recommendations to 

the Secretary. 

As always, the Committee welcomes 

hearing from anyone wishing to provide 

public comment on any issue related to 

genetics, health and society. Individuals 

who would like to provide public 

comment should notify the SACGHS 

Executive Secretary, Ms. Sarah Carr, by 

telephone at 301–496–9838 or e-mail at 

carrs@od.nih.gov. The SACGHS office is 

located at 6705 Rockledge Drive, Suite 

750, Bethesda, MD 20892. Anyone 

planning to attend the meeting who is 

in need of special assistance, such as 

sign language interpretation or other 

reasonable accommodations, is asked to 

contact the Executive Secretary. 

Under authority of 42 U.S.C. 217a, 

section 222 of the Public Health Service 

Act, as amended, the Department of 

Health and Human Services established 

SACGHS to serve as a public forum for 

deliberations on the broad range of 

human health and societal issues raised 

by the development and use of genetic 

and genomic technologies and, as 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 3 / Friday, January 4, 2008 / Notices 865 

warranted, to provide advice on these 

issues. The draft meeting agenda and 

other information about SACGHS, 

including information about access to 

the Web cast, will be available at the 

following Web site: http:// 

www4.od.nih.gov/oba/sacghs.htm. 

Dated: December 21, 2007. 

Jennifer Spaeth, 

Director, NIH Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–6274 Filed 1–3–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0485] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Food and Drug Administration 

Approval to Market a New Drug 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements governing applications for 

FDA approval to market a new drug. 

DATES: Submit written or electronic 

comments on the collection of 

information by March 4, 2008. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments or http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson,Office of the Chief 

Information Officer (HFA 250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4816. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Application for FDA Approval to 

Market a New Drug—(OMB Control 

Number 0910–0001)—Extension 

Under section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(a)), a new drug may not 

be commercially marketed in the United 

States, imported, or exported from the 

United States, unless an approval of an 

application filed with FDA under 

section 505(b) or 505(j) of the act is 

effective with respect to such drug. 

Under the act, it is the sponsor’s 

responsibility to provide the 

information needed by FDA to make a 

scientific and technical determination 

whether the product is safe and effective 

for use. 

This information collection approval 

request is for all information 

requirements imposed on sponsors by 

the regulations under part 314 (21 CFR 

part 314), who apply for approval of a 

new drug application (NDA) or 

abbreviated new drug application 

(ANDA) in order to market or to 

continue to market a drug. 

Section 314.50(a) requires that an 

application form (Form FDA 356h) be 

submitted that includes introductory 

information about the drug as well as a 

checklist of enclosures. 

Section 314.50(b) requires that an 

index be submitted with the archival 

copy of the application and that it 

reference certain sections of the 

application. 

Section 314.50(c) requires that a 

summary of the application be 

submitted that presents a good general 

synopsis of all the technical sections 

and other information in the 

application. 

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; and statistical section. 

Section 314.50(e) requires the 

applicant to submit samples of the drug 

if requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug. 

Section 314.50(f) requires that case 

report forms and tabulations be 

submitted with the archival copy. 

Section 314.50(h) requires that patent 

information, as described under 

§ 314.53, be submitted with the 

application. (The burden hours for 

§ 314.50(h) are already approved by 

OMB under OMB control number 0910–

0513 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.50(i) requires that patent 

certification information be submitted 

in section 505(b)(2) applications for 

patents claiming the drug, drug product, 

or method of use. 

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application. 

Section 314.50(k) requires that an 

archival, review, and field copy of the 

application be submitted. 

Section 314.52 requires that any 

notice of certification of invalidity or 

noninfringement of a patent to each 

patent owner and the NDA holder be 

sent by a section 505(b)(2) applicant that 

relies on a listed drug. A 505(b)(2) 

applicant is required to amend its 

application at the time notice is 

provided to include a statement 

certifying that the required notice has 


jlentini on PROD1PC65 with NOTICES