Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 15617 

Dated: March 18, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–06601 Filed 3–23–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0663] 

Determining the Need for and Content 

of Environmental Assessments for 

Gene Therapies, Vectored Vaccines, 

and Related Recombinant Viral or 

Microbial Products; Guidance for 

Industry: Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Determining the Need for and Content 

of Environmental Assessments for Gene 

Therapies, Vectored Vaccines, and 

Related Recombinant Viral or Microbial 

Products; Guidance for Industry’’ dated 

March 2015. The guidance document 

provides investigational new drug 

application (IND) sponsors and 

applicants for a biologics license 

application (BLA) or a supplement to a 

BLA (BLA supplement), with 

recommendations on considerations 

when assessing whether to submit an 

Environmental Assessment (EA) for 

gene therapies, vectored vaccines, and 

related recombinant viral or microbial 

products (GTVVs). The guidance also 

contains recommendations as to what 

information should be included in an 

EA and what you can expect once an EA 

is filed. The guidance announced in this 

notice finalizes the draft guidance of the 

same title dated June 2014. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

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: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Determining the 

Need for and Content of Environmental 

Assessments for Gene Therapies, 

Vectored Vaccines, and Related 

Recombinant Viral or Microbial 

Products; Guidance for Industry’’ dated 

March 2015. The guidance document 

provides IND sponsors and applicants 

for a BLA or a BLA supplement, with 

recommendations on considerations 

when assessing whether to submit an 

EA for GTVVs. The guidance also 

contains recommendations as to what 

information should be included in an 

EA and what you can expect once an EA 

is filed. The guidance supplements the 

guidance entitled ‘‘Guidance for 

Industry: Environmental Assessment of 

Human Drug and Biologics 

Applications’’ dated July 1998 (July 27, 

1998, 63 FR 40127) (1998 Guidance) and 

supersedes the recommendations for 

GTVVs in section IV.B.1 ‘‘Assessing 

Toxicity to Environmental Organisms’’ 

in the 1998 Guidance. The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

June 2014. 

In the Federal Register of June 20, 

2014 (79 FR 35361), FDA announced the 

availability of the draft guidance of the 

same title dated June 2014. FDA 

received a few comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. There were no changes to the 

guidance except for one correction to a 

technical error regarding influenza 

taxonomy. The guidance announced in 

this notice finalizes the draft guidance 

dated June 2014. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. 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. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are 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 collections of information in 

21 CFR part 25 have been approved 

under OMB control number 0910–0322; 

the collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014; and 

the collections of information for 21 

CFR part 601 have been approved under 

OMB control number 0910–0338. 

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 guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: March 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06686 Filed 3–23–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Economic Studies of 

Immunization Policies and Practices, 

Funding Opportunity Announcement 

(FOA) IP15–001 and US Platform to 

Measure Influenza Vaccine 

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15618 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 

Effectiveness against LaboratoryConfirmed Influenza-Associated 

Hospitalizations, FOA IP15–002, initial 

review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time And Date: 10:00 a.m.–4:00 p.m., 

April 15, 2015 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters For Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Economic Studies of Immunization 

Policies and Practices’’, FOA IP15–001 

and ‘‘US Platform to Measure Influenza 

Vaccine Effectiveness against 

Laboratory-confirmed Influenzaassociated Hospitalizations’’, FOA IP15– 

002. 

Contact Person For More Information: 

Gregory Anderson, M.S., M.P.H., 

Scientific Review Officer, CDC, 1600 

Clifton Road NE., Mailstop E60, Atlanta, 

Georgia 30333, Telephone: (404) 718– 

8833. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–06651 Filed 3–23–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Detection and Characterization 

of Emerging Vector-Borne Zoonotic 

Pathogens in Indonesia, CK15–001; 

Sentinel Enhanced Dengue Surveillance 

System (SEDSS) Sites to Evaluate the 

Epidemiology and Prevention of Dengue 

and other Acute Febrile Illnesses in 

Puerto Rico, CK15–002, and Capacity 

Building to Prevent, Detect, and 

Respond to Emerging Infectious Disease 

Threats and Strengthen Global Health 

Security in Uganda, CK15–003, Funding 

Opportunity Announcement (FOA), 

initial review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time And Date: 11:00 a.m.–3:00 p.m., 

April 21, 2015 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 552b(c) 

(4) and (6), Title 5 U.S.C., and the 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters For Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Detection and Characterization of 

Emerging Vector-Borne Zoonotic 

Pathogens in Indonesia’’, FOA CK15– 

001 and ‘‘Sentinel Enhanced Dengue 

Surveillance System (SEDSS) Sites to 

Evaluate the Epidemiology and 

Prevention of Dengue and other Acute 

Febrile Illnesses in Puerto Rico’’, FOA 

CK15–002, and ‘‘Capacity Building to 

Prevent, Detect, and Respond to 

Emerging Infectious Disease Threats and 

Strengthen Global Health Security in 

Uganda’’, FOA CK15–003. 

Contact Person For More Information: 

Gregory Anderson, M.S., M.P.H., 

Scientific Review Officer, CDC, 1600 

Clifton Road NE., Mailstop E60, Atlanta, 

Georgia 30333, Telephone: (404) 718– 

8833 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–06652 Filed 3–23–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–15GD] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Emergency Self Escape for Coal 

Miners—New—National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

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