14588 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 

print and online materials, outreach 

activities, and messages to maximize 

their impact and usefulness. 

OCPL wishes to continue to carry out 

formative research to further understand 

the knowledge, attitudes, and behaviors 

of its core constituent groups: members 

of the general public, researchers, and 

providers of both conventional and 

CAM health care. In addition, it seeks to 

test newly formulated messages and 

identify barriers and impediments to the 

effective communication of those 

messages. With this audience research, 

OCPL will carry out pretesting of 

audience responses to NCCAM’s fact 

sheets, Web content, and other materials 

and messages. 

Clearance is also requested to 

continue to carry out evaluative 

research on existing materials and 

messages, as part of OCPL’s ongoing 

effort to develop a comprehensive 

program of testing and evaluation of all 

of its communications strategies. This 

evaluative research will include pilot 

testing of recently developed messages 

and information products such as fact 

sheets and brochures. It will also 

address the need to evaluate the 

processes by which new materials and 

messages were developed, the 

effectiveness of an outreach or the 

extent to which behaviors were changed 

by the message, and the impact of a 

message on health knowledge and 

behaviors. 

The tools to collect this information 

have been selected to minimize burden 

on NCCAM’s audiences, produce or 

refine messages that have the greatest 

potential to influence target audience 

attitudes and behavior in a positive 

manner, and to use Government 

resources efficiently. They may include 

individual in-depth interviews, focus 

group interviews, intercept interviews, 

self-administered questionnaires, 

gatekeeper reviews, and omnibus 

surveys. 

The data will enhance OCPL’s 

understanding of (1) the unique 

information needs and distinct healthinformation-seeking behaviors of its 

core constituencies, and (2) the 

segments within these constituencies 

with special information needs (for 

example, among the general public 

these segments include cancer patients, 

the chronically ill, minority and ethnic 

populations, the elderly, users of dietary 

supplements, and patients integrating 

complementary therapies with 

conventional medical treatments). 

Frequency of Response: On occasion. 

Affected Public: Individuals and 

households; non-profit institutions; 

Federal Government; State, Local, or 

Tribal Government. 

Type of Respondents: Adult patients; 

members of the public; health care 

professionals; organizational 

representations. The annual reporting 

burden is as follows. 

Estimated Number of Respondents: 

2,440; 

Estimated Number of Responses per 

Respondent: 1; 

Average Burden Hours per Response: 

0.29; and 

Estimated Total Burden Hours 

Requested: 2,137.5 for the 3-year 

clearance period (approximately 712.5 

hours annually). The annualized cost to 

respondents is estimated at $21,333. 

There are no Capital Costs, Operating 

Costs, or Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on 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 assumption 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. 

For Further Information Contact: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, NCCAM, 31 Center 

Drive, Room 2B11, Bethesda, MD 20892, 

or fax your request to 301–402–4741, or 

e-mail thomsenc@mail.nih.gov. Ms. 

Thomsen can be contacted by telephone 

at 301–451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: March 20, 2007. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E7–5671 Filed 3–27–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

List of Drugs for Which Pediatric 

Studies Are Needed 

ACTION: Notice. 

SUMMARY: The National Institutes of 

Health (NIH) is providing notice of the 

‘‘Priority List of Drugs for Which 

Pediatric Studies Are Needed.’’ The NIH 

develops the list in consultation with 

the Food and Drug Administration 

(FDA) and pediatric experts, as 

mandated by the Best Pharmaceuticals 

for Children Act. This list prioritizes 

certain drugs that are most in need of 

study for use by children to ensure their 

safety and efficacy. The NIH will update 

the list at least annually until the Act 

expires on October 1, 2007. 

DATES: The list is effective upon 

publication. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Perdita Taylor-Zapata, National Institute 

of Child Health and Human 

Development (NICHD), 6100 Executive 

Boulevard, Suite 4A–01, Bethesda, MD 

20892–7510, e-mail 

taylorpe@mail.nih.gov or 

BestPharmaceuticals@mail.nih.gov, 

telephone 301–496–9584 (not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: The NIH 

is providing notice of the ‘‘List of Drugs 

for Which Pediatric Studies Are 

Needed,’’ as authorized under Section 3, 

Public Law 107–109 (42 U.S.C. 409I). 

On January 4, 2002, President Bush 

signed into law the Best 

Pharmaceuticals for Children Act 

(BPCA). The BPCA mandates that not 

later than one year after the date of 

enactment, the NIH in consultation with 

the FDA and experts in pediatric 

research shall develop, prioritize, and 

publish an annual list of certain 

approved drugs for which pediatric 

studies are needed. For inclusion on the 

list, an approved drug must meet the 

following criteria: (1) There is an 

approved application under section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(j)); (2) there 

is a submitted application that could be 

approved under the criteria of section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act; (3) there is no patent 

protection or market exclusivity 

protection under the Federal Food, 

Drug, and Cosmetic Act; or (4) there is 

a referral for inclusion on the list under 

section 505A(d)(4)(c); and additional 

studies are needed to assess the safety 

and effectiveness of the use of the drug 

in the pediatric population. The BPCA 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 14589 

further stipulates that in developing and 

prioritizing the list, the NIH shall 

consider for each drug on the list: (1) 

The availability of information 

concerning the safe and effective use of 

the drug in the pediatric population; (2) 

whether additional information is 

needed; (3) whether new pediatric 

studies concerning the drug may 

produce health benefits in the pediatric 

population; and (4) whether 

reformulation of the drug is necessary. 

For this year, we are providing an 

update and a summary of the progress 

made by the prioritization working 

group from last year’s notice until now, 

as well as a summary of the annual 

scientific prioritization meeting held 

with pediatric experts on December 5–

6, 2006. 

We have updated the complete list of 

drugs, listed previously in the April 

2006 Federal Register notice, and post 

it on the BPCA Web site http:// 

bpca.nichd.nih.gov/index.cfm. We will 

continue to reevaluate this list 

throughout the year and will provide 

updates as required, based upon the 

reauthorization of the BPCA. 

In 2005, and with the suggestion of 

pediatric experts, NIH changed the 

listing system from a focus on 

individual off-patent drugs to a 

therapeutic class-based approach. 

Pediatric experts indicated that this 

approach will allow us to compare 

drugs within a therapeutic class (on and 

off patent) and give a broader 

description of the use of these drugs in 

children. This approach will also allow 

us to obtain focused expertise in 

therapeutic areas that will subsequently 

give us more insight into scientific gaps 

in treatments of the proposed 

conditions, as well as feasibility and 

study designs. Based on expert opinion 

obtained throughout the year as part of 

our regular outreach program, a 

preliminary list of conditions and 

suggested drugs was drafted and 

categorized for the 2007 prioritization 

based on this approach. 

The following are the conditions and 

the drugs discussed in our December 5–

6, 2006 scientific meeting with experts 

in pediatric research: Infectious 

Diseases, with a focus on Methicillinresistant Staphylococcus aureus (MRSA) 

infections; Pediatric Cancer, specifically 

Neuroblastoma; Neonatal Pain; and 

Asthma. The gaps in scientific 

knowledge as well as specific drugs 

thought to be effective for treatment in 

each of these conditions were then 

discussed based on off-patent status, 

gaps in pediatric labeling, and the 

potential for providing a health benefit 

in the general pediatric population. We 

also provided updates on our current 

work in the areas of Pediatric 

Hypertension, Sickle Cell Anemia, and 

Attention Deficit Hyperactivity Disorder 

during this meeting. There was also a 

brief discussion on future areas of 

consideration, pending the 

reauthorization of the BPCA, that 

include topics such as childhood 

obesity, counter-terrorism research, and 

Fragile X Syndrome. 

Following below are the conditions 

and drugs we discussed in the 

December 5–6, 2006, scientific meeting 

with experts in pediatric research. We 

will add these conditions and drugs, 

and their indications for use, to the 

Priority List for 2007 for which pediatric 

studies are most urgently needed. 

Treatment of Pediatric Cancers: 13-CisRetinoic Acid 

There is a need for information 

regarding the pharmacokinetics, safety, 

and efficacy of 13-Cis-Retinoic Acid in 

the treatment of neuroblastoma. 

Treatment of Pediatric MRSA: 

Clindamycin, Tetracycline, Doxycycline 

and Trimethoprim-Sulfamethoxazole 

There is a need for further 

pharmacokinetic and safety data in the 

use of these drugs to treat children with 

MRSA infections. 

In addition to the above conditions 

and their associated drugs for 

consideration, the following are 

conditions that have been identified as 

needing improvements in the treatment 

strategies and/or assessments in 

pediatrics. 

Pediatric Hypertension 

Data from the medical literature, 

clinical trials, and experience were 

presented and discussed by experts in 

the field of Pediatric Hypertension. 

Gaps in knowledge in this field include 

standardization of blood pressure 

measurements in children as well as the 

sequence of drugs for hypertension 

treatment in children. 

Asthma 

Data from the medical literature, 

clinical trials, and experience were 

presented and discussed by experts in 

the field of Pediatric Asthma. Gaps in 

knowledge in this field include gaps in 

measuring efficacy and safety of 

treatments and drug delivery systems, 

especially in young children. There is 

also a need for the development of new 

tools to identify symptom measures, 

pulmonary function tests, biomarkers, 

and genetics. 

Neonatal Research 

There are many areas in the field of 

neonatal medicine that can benefit from 

advances in neonatal research. Such 

gaps in research include areas such as 

determining feasibility of studying 

specific drugs in low-birth-weight 

infants based on current use; the 

development of novel study designs that 

take into account the small number of 

patients available due to either ethical 

limitations and/or feasibility issues; and 

the performance of clinical studies in 

areas such as the treatment of pain, 

neonatal seizures, and 

bronchopulmonary dysplasia, based on 

templates that are being developed by 

experts in research such as the working 

groups of the Newborn Drug 

Development Initiative. 

For the coming year, NICHD is 

planning a series of discussions with 

experts in the fields listed above and 

plans to identify and work with experts 

in these respective fields along with our 

continuing discussions with the other 

NIH Institutes and Centers. The goal of 

all of these discussions will be to 

specifically identify current gaps in 

scientific knowledge regarding research 

and treatment of these various pediatric 

conditions with the ultimate goal of 

determining future approved drugs for 

which pediatric studies are needed. 

Dated: March 15, 2007. 

Raynard S. Kington, 

Deputy Director, National Institutes of Health. 

[FR Doc. E7–5673 Filed 3–27–07; 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 


sroberts on PROD1PC70 with NOTICES