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Draft Guidance for Industry on 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availability of a draft guidance for 

industry entitled ‘‘Draft Guidance on 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This draft guidance provides 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
63922 Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Notices 

• limitations for use of the 

Galactomannan assay; 

• considerations for sample 

acquisition and documentation; 

• analysis of study results; and 

• performance characteristics of the 

assay. 

Innovative and improved DDTs can 

help streamline the drug development 

process, improve the chances for 

clinical trial success, and yield more 

information about a treatment and/or 

disease. DDTs include, but are not 

limited to, biomarkers, clinical outcome 

assessments and animal models. Refer 

to DDTs Qualification Programs at 

http://www.fda.gov/Drugs/

DevelopmentApprovalProcess/

DrugDevelopmentTools

QualificationProgram/default.htm for 

additional information. 

As stated previously in the Federal 

Register of January 7, 2014 (79 FR 831), 

FDA announced the availability of the 

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 at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. CDER has 

developed this formal process to work 

with developers of these biomarker 

DDTs to guide the developers as they 

refine the tools and rigorously evaluate 

them for use in the regulatory context. 

Once qualified, DDTs will be publicly 

available for use in any drug 

development program for the qualified 

context of use. As described in the 

January 2014 guidance, biomarker DDTs 

should be developed and reviewed 

using this process. 

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 Galactomannan in serum and BAL 

fluid. 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. The Paperwork Reduction Act of 

1995 

This guidance contains an 

information collection that is subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The information collection has 

been approved under the OMB control 

numbers 0910–0001 and 0910–0014. 

The information requested in the 

guidance is currently submitted to FDA 

to support medical product 

effectiveness (see 21 CFR 312.30, 21 

CFR 314.50(d)(5), and 21 CFR 

314.126(b)(6)). 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number 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, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

V. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday, and is available 

electronically at http://

www.regulations.gov. 

1. De Pauw, B., T.J. Walsh, J.P. 

Donnelly, et al., ‘‘Revised Definitions of 

Invasive Fungal Disease from European 

Organization for Research and 

Treatment of Cancer/Invasive Fungal 

Infections Cooperative Group and the 

National Institute of Allergy and 

Infectious Diseases Mycoses Study 

Group (EORTC/MSG) Consensus 

Group,’’ Clinical Infectious Diseases 

(2008) 46: 1813–1821. 

Dated: October 21, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25532 Filed 10–24–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2013–1078] 

National Offshore Safety Advisory 

Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of Federal Advisory 

Committee meetings. 

SUMMARY: The National Offshore Safety 

Advisory Committee and its 

Subcommittees will meet on November 

18 and 19, 2014, in Houston, TX, to 

discuss the safety of operations and 

other matters affecting the offshore oil 

and gas industry. These meetings are 

open to the public. 

DATES: Subcommittees of the National 

Offshore Safety Advisory Committee 

will meet on Tuesday, November 18, 

2014, from 1 p.m. to 4 p.m. and the full 

Committee will meet on Wednesday, 

November 19, 2014, from 8:30 a.m. to 

4:30 p.m. These meetings may end early 

if the Committee has completed its 

business, or they may be extended based 

on the number of public comments. All 

submitted written materials, comments, 

and requests to make oral presentations 

at the meetings should reach the Coast 

Guard (see FOR FURTHER INFORMATION

CONTACT) by November 1, 2014. Any 

written material submitted by the public 

will be distributed to the Committee and 

become part of the public record. 

ADDRESSES: The meetings will be held 

in the conference room of the American 

Bureau of Shipping, 15011 Katy 

Freeway, Suite 100, Houston, TX, 

77094, 832–391–3300, http://

www.eagle.org. 

For information on facilities or 

services for individuals with 

disabilities, or to request special 

assistance at the meetings, contact the 

individuals listed in FOR FURTHER

INFORMATION CONTACT section, as soon as 

possible. 

To facilitate public participation, we 

are inviting public comment on the 

issues to be considered by the 

Committee as listed in the ‘‘Agenda’’ 

section below. Written comments for 

distribution to Committee members 

must be submitted no later than 

November 1, 2014, if you want the 

Committee members to be able to review 

your comments before the meeting, and 

must be identified by docket number 

USCG–2013–1078 and submitted by one 

of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 


tkelley on DSK3SPTVN1PROD with NOTICES