Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 15703 

accompanied by FDA senior 

management from the Office of the 

Commissioner, the Office of Policy and 

Planning, the Office of the Chief 

Counsel, the Center for Drug Evaluation 

and Research, and the Center for 

Biologics Evaluation and Research. 

Persons who wish to participate in the 

part 15 hearing must file a written or 

electronic notice of oral presentation 

with the Division of Dockets 

Management (see ADDRESSES and 

DATES). To ensure timely handling of 

written submissions, any outer envelope 

should be clearly marked with the 

docket number found in brackets in the 

heading of this document, along with 

the statement ‘‘Electronic Distribution of 

Package Inserts for Prescription Drug 

Products.’’ Requests to make an oral 

presentation should contain the 

potential presenter’s name and title; 

address; telephone and fax number; email address; affiliation, if any; the 

sponsor of the presentation (e.g., the 

organization paying travel expenses or 

fees), if any; and a brief summary of the 

presentation (including the discussion 

topic(s) that will be addressed). 

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10, subpart C)). Under 

§ 10.205, representatives of the 

electronic media may be permitted, 

subject to certain limitations, to 

videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. 

To the extent that the conditions for 

the hearing, as described in this 

document, conflict with any provisions 

set out in part 15, this document acts as 

a waiver of those provisions as specified 

in § 15.30(h). 

VI. Requests for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of oral presentation and comments for 

consideration. To permit time for all 

interested persons to submit data, 

information, or views on this subject, 

the administrative record of the hearing 

will remain open until June 22, 2007. 

Persons who wish to provide additional 

materials for consideration should file 

these materials with the Division of 

Dockets Management (see ADDRESSES). 

You should annotate and organize your 

comments to identify the specific 

questions identified by topic to which 

they refer (see section IV of this 

document). Two paper copies of any 

mailed comments are to be submitted, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number at the 

heading of this document. Received 

comments may be seen in Division of 

Dockets Management (see ADDRESSES) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

VII. Transcripts 

The hearing will be transcribed as 

stipulated in § 15.30(b). Transcripts of 

the hearing will be available for review 

at the Division of Dockets Management 

(see ADDRESSES) and on the Internet at 

http://www.fda.gov/ohrms/dockets 

approximately 21 days after the hearing. 

You may place orders for copies of the 

transcript through the Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers lane, 

rm. 6–30, Rockville, MD 20857, at a cost 

of 10 cents per page. 

Dated: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1604 Filed 3–28–07; 1:02 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Health Information National 

Trends Survey 2007 (HINTS 2007) 

Summary: In compliance with the 

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

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) 

request a review and approval of the 

information listed below. The proposed 

information collection was previously 

published in the Federal Register on 

October 26, 2006 on page 62597 and 

allowed 60 days for public comment. 

One public comment was 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: Health 

Information National Trends Survey 

2007 (HINTS 2007). Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: Building on 

the first two rounds of HINTS data 

collection (HINTS 2003: OMB #0925–

0507, Exp. Date: 8/31/03; and HINTS 

2005: OMB # 0925–0538, Exp. Date 11/ 

30/2007), HINTS 2007 will continue to 

provide NCI with a comprehensive 

assessment of the American public’s 

current access to, and use of, 

information about cancer, including 

cancer prevention, early detection, 

diagnosis, treatment, and prognosis. The 

content of the survey will focus on 

understanding the degree to which 

members of the general population 

understand vital cancer prevention 

messages. More importantly, this NCI 

survey will couple knowledge-related 

questions with inquiries into the 

communication channels through which 

understanding is being obtained. HINTS 

is intended to be the foundation of NCI’s 

effort to build on the opportunities 

presented by a national shift in 

communication context (for example, 

the increase in information available on 

the Internet and the use of email as a 

method of communication), and by so 

doing, improve the nation’s ability to 

reduce the national cancer burden. Data 

will be used (1) to understand 

individuals sources of and access to 

cancer-related information; (2) to 

measure progress in improving cancer 

knowledge and communication to the 

general public; (3) to develop 

appropriate messages for the public 

about cancer prevention, detection, 

diagnosis, treatment, and survivorship; 

and (4) to identify research gaps and 

guide decisions about NCI’s research 

efforts in health promotion and health 

communication. Frequency of Response: 

One time. Affected Public: Individuals. 

Type of Respondents: U.S. Adults. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

11,670; Estimated Number of Responses 

per Respondent: 1.36; Average Burden 

Hours per Response: .24; and Estimated 

Total Annual Burden Hours Requested: 

3,739. The annualized cost to 

respondents is estimated at: $59,824. 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 


hsrobinson on PROD1PC76 with NOTICES
15704 Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 

Type of respondent 

Estimated 

number of 

respondents 

Frequency of 

response 

Estimated 

number of 

responses 

Average hours 

per response 

Annual hour 

burden 

Respondent 

cost** 

Pilot RDD screener only .......................... 133 1 133 .0833 11 $176 

Pilot RDD screener and interview ........... 200 2 400 *.2500 100 1,600 

Additional RDD screeners for advance 

materials test ........................................ 450 1 450 .0833 37 592 

Pilot mail survey ....................................... 640 1 640 .3333 213 3,408 

RDD screener only .................................. 2,333 1 2,333 .0833 194 3,104 

RDD screener and interview .................... 3,500 2 7,000 *.2500 1,750 28,000 

Mail survey ............................................... 3,500 1 3,500 .3333 1,167 18,672 

Telephone screener only for mail followup .................................................... 457 1 457 .0833 38 608 

Telephone screener and interview for 

mail followup ......................................... 457 2 914 *.2500 229 3,664 

Total .................................................. 11,670 ........................ 15,827 ........................ 3,739 59,824 

* (0.833 + 0.4167) / 2 = 0.2500. 

** Hourly wage rate = $16.00. 

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 estimated public 

burden and associated response time, 

should be directed to the: Office of 

Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Office for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Bradford 

W. Hesse, PhD, Project Officer, National 

Cancer Institute, NIH, EPN 4068, 6130 

Executive Boulevard MSC 7365, 

Bethesda, Maryland 20892–7365, or call 

non-toll-free number 301–594–9904, or 

FAX your request to 301–480–2198, or 

E-mail your request, including your 

address, to hesseb@mail.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: March 23, 2007. 

Rachelle Ragland-Greene, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. E7–6064 Filed 3–30–07; 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. 

High-Level Expression and Purification 

of Untagged and Histidine-Tagged 

Human Immunodeficiency Virus type-1 

(HIV–1) Reverse Transcriptase 

Description of Technology: This 

invention includes plasmids and 

protocols to express and purify large 

quantities of histidine-tagged and 

untagged HIV–1 reverse transcriptase 

(RT). Conditions have been optimized 

for overexpression and purification of 

p66 and p51 heterodimer RT in E. coli. 

High-level of expression was reached as 

RT represented approximately 30%–

40% of total cell proteins. The subject 

invention enables the purification of 

large quantities of heterodimer RT 

necessary for structural and kinetic 

studies and facilitates subunit-specific 

amino acid alterations essential for 

structure/function investigations. 

Applications: Research Tool. 

Development Status: In vitro data 

available. 

Inventors: Samuel H. Wilson, 

Rajendra Prasad, Esther W. Hou 

(NIEHS). 

Related Publication: EW Hou, R 

Prasad, WA Beard, SH Wilson. Highlevel expression and purification of 

untagged and histidine-tagged HIV–1 

reverse transcriptase. Protein Expr Purif. 

2004 Mar;34(1):75–86. 

Patent Status: HHS Reference No. E–

141–2007/0—Research Tool. 

Licensing Status: Available for nonexclusive licensing as biological 

material and research tool. 

Licensing Contact: Sally Hu, PhD; 

301/435–5606; HuS@mail.nih.gov. 

Methods of Determining the Prognosis 

of an Adenocarcinoma 

Description of Technology: Available 

for licensing and commercial 

development is a novel method for 

determining the prognosis of a subject 

with adenocarcinoma in an organ, such 


hsrobinson on PROD1PC76 with NOTICES