15616 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 

Group 3 will receive a mailing about the 

registry, whereas Group 4 the 

comparison group will not receive any 

outreach component. To analyze the 

change in ALS registry self-enrollment, 

ATSDR will compare, on a monthly 

basis, enrollment rates between Groups 

1, 2, and 3, and 4, as well as with the 

44-state Group 4. 

Study activities include, but are not 

limited to, initial and follow-up phone 

calls, mailings, train-the-trainer 

sessions, and key informant interviews. 

The initial phone call will: (1) 

determine if the neurologist(s) diagnose/ 

care for patients with ALS; (2) 

determine how many ALS patients are 

seen on an annual basis, and (3) confirm 

contact information for neurologists. 

Providers who do or would diagnose/ 

care for patients with ALS will receive 

a targeted mailing about the registry. 

Follow-up phone calls and faxes, as 

needed, will confirm the receipt of 

mailings (including posters, provider 

guide pamphlet, Persons with ALS 

Quick Start Guide etc.). Key informant 

interviews with neurologists will allow 

for better understanding of their 

knowledge, attitudes, and beliefs about 

the Registry, and for gathering 

additional information about the 

currently deployed Registry materials. 

As neurologists may not be familiar 

with the self-enrollment process of the 

Registry, the project includes train-thetrainer site visits that will provide 

neurologists and staff (if requested to 

attend by the neurologist) with 

information to educate persons with 

ALS about the National ALS Registry 

self-enrollment process. The train-thetrainer module activities do not involve 

information collections. 

Participation is voluntary. For the 

duration (2 years), the project staff will 

conduct 3,800 initial phone calls, 1,900 

follow-up #1 calls at one week postmailing, 1,900 follow-up #2 calls at 

three months post-mailing, 30 train-thetrainer presentations, and 32 keyinformant interviews. 

There are no costs to respondents 

other than their time. The estimated 

annualized burden hours for this data 

collection activity are 326. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Neurologist Support Staff .................. Initial Phone Call Checklist .............. 1,900 1 6/60 190 

Neurologist Support Staff .................. Fax to Determine Provider Status ... 380 1 1/60 6 

Neurologist Support Staff .................. Follow-up Phone Call #1 (One 

Week Post-Mailing).

950 1 3/60 48 

Neurologist Support Staff .................. Follow-up Phone Call #2 (Three 

Months Post-Mailing).

950 1 3/60 48 

Neurologist Support Staff .................. Fax to Determine if Mailing Was Received.190 1 1/60 3 

Neurologist ........................................ Train-the-Trainer .............................. 15 1 1 15 

Neurologist ........................................ Key Informant Interview ................... 16 1 1 16 

Total ........................................... ........................................................... ........................ ........................ ........................ 326 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–06654 Filed 3–23–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Basic Research in HIV-Related Heart, Lung 

and Blood Diseases. 

Time: April 16, 2015. 

Time: 8:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Washington, DC 

Dupont Circle Hotel, 1143 New Hampshire 

Avenue NW., Washington, DC 20037. 

Contact Person: Susan Wohler Sunnarborg, 

Ph.D. Scientific Review Officer, Office of 

Scientific Review/DERA National, Heart, 

Lung, and Blood Institute, 6701 Rockledge 

Drive, Room 7182, Bethesda, MD 20892, 

sunnarborgsw@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Translational Programs in Lung Diseases. 

Date: April 16, 2015. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crystal City Marriott, 1999 Jefferson 

Davis Highway, Arlington, VA 22202. 

Contact Person: William J. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7178, Bethesda, MD 20892–7924, 301–435– 

0725, johnsonwj@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Basic Research in HIV-Related Heart, Lung 

and Blood Diseases (R21). 

Date: April 16, 2015. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Washington, DC 

Dupont Circle Hotel, 1143 New Hampshire 

Avenue NW., Washington, DC 20037. 

Contact Person: Susan Wohler Sunnarborg, 

Ph.D. Scientific Review Officer, Office of 

Scientific Review/DERA National, Heart, 

Lung, and Blood Institute, 6701 Rockledge 

Drive, Room 7182, Bethesda, MD 20892, 

sunnarborgsw@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

mstockstill on DSK4VPTVN1PROD with NOTICES

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 

mstockstill on DSK4VPTVN1PROD with NOTICES