63920 Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Notices 

laboratory services. Such issues may 

include the development, validation, 

performance, safety, and application of 

such tests. Nominees must demonstrate 

personal experience with clinical 

laboratory tests and services through a 

past or present history of direct 

employment with an organization that 

furnishes clinical diagnostic laboratory 

tests, or in an academic or research 

capacity. For purposes of this Panel, 

consultants or independent contractors 

are not considered to be representatives 

of clinical laboratories. 

All members will serve on a voluntary 

basis, without compensation, pursuant 

to advance written agreement. Members 

of the Panel will be entitled to receive 

reimbursement for travel expenses and 

per diem in lieu of subsistence 

expenses, in accordance with standard 

Federal Travel Regulations. A member 

may serve after the expiration of his/her 

term until a successor has been sworn 

in. 

The nominees will be evaluated based 

on expertise and factors needed to 

maintain a balance of representation on 

the Panel. These factors include, but are 

not limited to, geographic area 

representation, female and minority 

representation, points of view, and areas 

of expertise (for example, medical, 

scientific, financial, technical, or 

administrative). In addition, all 

nominees must have at least 5 years of 

experience with clinical diagnostic 

laboratory tests or genetic testing. 

Nominations will be considered from 

all geographic locations within the 

United States or its territories. Any 

organization or person may nominate 

one or more qualified individuals for 

Panel membership. Self-nominations 

will also be accepted. 

Each nomination must state that the 

nominee has expressed a willingness to 

serve as a Panel member and must be 

accompanied by a curriculum vitae and 

a brief biographical summary of the 

nominee’s experience. All curricula 

vitae must include the following: 

• Title and current position. 

• Professional affiliation. 

• Home and business address. 

• Telephone and fax numbers. 

• Email address. 

• List of areas of expertise. 

In addition, each nomination letter must 

include the reasons why the nominee 

should be considered, as well as a 

written and signed statement that the 

nominee is willing to serve on the Panel 

under the conditions described in the 

notice and further specified in the 

Charter. 

The top nominees will be contacted in 

regard to their interest and availability. 

Phone interviews of nominees may also 

be requested after review of the 

nominations. The CMS Administrator or 

designee will make the final decision 

about who will serve on the Panel. 

Formal letters of invitation to serve on 

the Panel will be extended by the CMS 

Administrator. 

To permit an evaluation of possible 

sources of conflict of interest, potential 

candidates will be asked to provide 

detailed information concerning such 

matters as financial holdings, 

consultancies, and research grants or 

contracts. 

The selected candidates will be 

invited to serve for a term of up to 3 

years, contingent upon the renewal of 

the Panel by appropriate action prior to 

its termination. A member may serve 

after the expiration of that member’s 

term until a successor takes office. Any 

member appointed to fill a vacancy for 

an unexpired term will be appointed for 

the remainder of that term. 

III. Copies of the Charter 

The Secretary’s Charter for the 

Advisory Panel on Clinical Diagnostic 

Laboratory Tests is available on the 

CMS Web site at http://www.cms.gov/ 

FACA/XXXXXXX.asp, or you may 

obtain a copy of the charter by 

submitting a request to the contact listed 

in the FOR FURTHER INFORMATION section 

of this notice. 

Dated: October 21, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–25401 Filed 10–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: Grant Reviewer 

Recruitment. 

Title: Grant Reviewer Recruitment 

Form. 

OMB No.: NEW. 

Description: The Administration for 

Children and Families’ Children’s 

Bureau (CB) is responsible for 

administering the review of eligible 

grant applications submitted in 

response to funding opportunity 

announcements issued by CB. CB 

ensures that the objective review 

process is independent, efficient, 

effective, economical, and complies 

with the applicable statutes, regulations, 

and policies. Applications are reviewed 

by subject experts knowledgeable in 

child welfare and related fields. Review 

findings are advisory to CB; CB is 

responsible for making award decisions. 

This announcement is a request for 

approval of the proposed information 

collection system, the Reviewer 

Recruitment Module (RRM). CB will use 

a web-based data collection form and 

database to gather critical reviewer 

information in drop down menu format 

for data such as: Degree, occupation, 

affiliations with organizations and 

institutions that serve special 

populations, and demographic 

information that may be voluntarily 

provided by a potential reviewer. 

These data elements will help CB find 

and select expert grant reviewers for 

objective review committees. The webbased system will permit reviewers to 

access and update their information at 

will and as needed. The RRM will be 

accessible by the general public via 

https://rrm.grantsolutions.gov/

AgencyPortal/cb.aspx. 

Respondents: Generally, our 

reviewers are current or retired 

professionals with backgrounds in child 

welfare and related fields and in some 

instances current or former foster care 

parents or clients. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Reviewer recruitment module .......................................................................... 500 1 .25 125 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Notices 63921 

Estimated Total Annual Burden 

Hours: 125. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–25526 Filed 10–24–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1630] 

Draft Guidance for Industry on 

Qualification for the Use of 

Galactomannan in Serum and 

Bronchoalveolar Lavage Fluid; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Draft Guidance on 

Qualification of Biomarker— 

Galactomannan in Studies of 

Treatments of Invasive Aspergillosis.’’ 

This draft guidance provides 

recommendations on the use of 

Galactomannan detection in serum and/ 

or bronchoalveolar lavage (BAL) fluid as 

the sole microbiological criterion to 

classify patients as having probable 

invasive Aspergillosis (IA) for 

enrollment in clinical trials. This draft 

guidance provides the context of use for 

which this biomarker drug development 

tool (DDT) is qualified through the 

Center for Drug Evaluation and Research 

(CDER) DDT Qualification Program. In 

the Federal Register of January 7, 2014, 

FDA announced the availability of a 

guidance for industry entitled 

‘‘Qualification Process for Drug 

Development Tools,’’ which described 

the process that would be used to 

qualify DDTs and to make new DDT 

qualification recommendations 

available on FDA’s Web site. The 

qualification recommendations in this 

draft guidance were developed using the 

process described in that guidance. 

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 

either electronic or written comments 

on the draft guidance by December 26, 

2014. 

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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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. 

FOR FURTHER INFORMATION CONTACT: 

Marianne Noone, Center for Drug 

Evaluation and Research (Office of 

Translational Sciences, Immediate 

Office), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 21, 

Rm. 4528, Silver Spring, MD 20993– 

0002, 301–796–2600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Draft Guidance on Qualification of 

Biomarker—Galactomannan in studies 

of treatments of invasive Aspergillosis.’’ 

This draft guidance provides 

recommendations on the use of 

Galactomannan detection in serum and/ 

or BAL fluid as the sole microbiological 

criterion to classify patients as having 

probable IA for enrollment in clinical 

trials. The draft guidance provides the 

context of use for which this biomarker 

DDT is qualified through the CDER DDT 

Qualification Program. Qualification of 

this biomarker for this specific context 

of use represents the conclusion that 

analytically valid measurements of the 

biomarker can be relied on to have a 

specific use and interpretable meaning. 

Further, the biomarker can be used by 

drug developers for the qualified 

context in submission of investigational 

new drug applications, new drug 

applications, and biologics licensing 

applications without the relevant CDER 

review group reconsidering and 

reconfirming the suitability of the DDT. 

Qualification means that the use of this 

biomarker in the specific context of use 

is not limited to a single, specific drug 

development program. Making the 

qualification recommendations widely 

known and available for use by drug 

developers will contribute to drug 

innovation, thus supporting public 

health. The draft guidance is an 

attachment to the guidance for industry 

entitled ‘‘Qualification Process for Drug 

Development Tools.’’ 

In March 2006, FDA issued the 

‘‘Critical Path Opportunities Report and 

List,’’ in which FDA described six key 

areas along the critical path to improved 

therapies and listed specific 

opportunities for advancement within 

these topic areas. The report noted that 

a new product development toolkit 

containing new scientific and technical 

methods was needed to improve the 

efficiency of drug development. 

In 2008, the Mycoses Study Group 

proposed using Galactomannan in 

serum and BAL fluid as an indicator of 

IA in lieu of culture in patients with 

hematologic malignancies and 

recipients of allogeneic hematopoietic 

stem cell transplants and who also have 

radiologic evidence suggestive of 

invasive fungal infection (Ref. 1). A 

qualification review team of experts 

evaluated the data supporting the 

proposed context of use and rendered a 

qualification recommendation. The 

qualification recommendation in the 

draft guidance includes the following 

information: 

• A use statement; 

• conditions for qualified use of the 

assay; 

• patient populations; 


tkelley on DSK3SPTVN1PROD with NOTICES