15614 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET— 

Continued 

Dates Electronic addresses Addresses Other information 

Submit electronic 

or written comments.

Submit comments by May 

26, 2015.

Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the instructions for submitting comments.

Mail/Hand delivery/Courier (for 

paper submissions): Division of 

Dockets Management (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

Identify your comments with the 

docket number listed in brackets in the heading of this document. We encourage you to 

submit electronic comments by 

using the Federal eRulemaking 

Portal. 

1You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott Dr., suite 111, Allen, TX 75013, 704– 

258–4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com. 

IV. Comments, Transcripts, and 

Recorded Video 

Regardless of attendance at the public 

meeting, interested persons may submit 

to FDA’s Division of Dockets 

Management (see Addresses in table 1 of 

this document) either electronic or 

written comments on FSMA 

implementation issues. You only need 

to send one set of comments. Identify 

the comments with the docket number 

listed in brackets in the heading of this 

document. However, we will not use 

any information or data submitted 

during the public meeting or through 

the docket to inform any FSMA 

rulemakings where the comment 

periods have closed. 

With respect to transcripts, please be 

advised that as soon as a transcript is 

available it will be accessible at http:// 

www.regulations.gov and at FDA’s 

FSMA Web site at http://www.fda.gov/ 

FSMA. You may also view the transcript 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Send 

written requests to the Division of 

Freedom of Information (ELEM–1029), 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. 

Additionally, we will be video 

recording the public meeting. Once the 

recorded video is available, it will be 

accessible at FDA’s FSMA Web site at 

http://www.fda.gov/FSMA. 

Dated: March 18, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06656 Filed 3–23–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Interagency Committee on Smoking 

and Health: Notice of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the 

Interagency Committee on Smoking and 

Health, Department of Health and 

Human Services, has been renewed for 

a 2-year period through March 20, 2017. 

For information, contact Simon 

McNabb, Designated Federal Officer, 

Interagency Committee on Smoking and 

Health, Centers for Disease Control and 

Prevention, Department of Health and 

Human Services, Patriot’s Plaza, 395 E 

Street SW., M/S P06, Washington, DC 

20201, telephone 202/245–0550 or fax 

202/245–0599, Email: BOL1@cdc.gov. 

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. 2015–06649 Filed 3–23–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[60Day–15–15TG; Docket No. CDC–2015– 

0009] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), Centers 

for Disease Control and Prevention 

(CDC). 

ACTION: Notice with comment period. 

SUMMARY: The Agency for Toxic 

Substances and Disease Registry 

(ATSDR), as part of its continuing 

efforts to reduce public burden and 

maximize the utility of government 

information, invites the general public 

and other Federal agencies to take this 

opportunity to comment on proposed 

and/or continuing information 

collections, as required by the 

Paperwork Reduction Act of 1995. This 

notice invites comment on Promotion of 

the National Amyotrophic Lateral 

Sclerosis (ALS) Registry to Non-referral 

Centers. 

DATES: Written comments must be 

received on or before May 26, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0009 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulation.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS– 

D74, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 15615 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment should be 

submitted through the Federal eRulemaking 

portal (Regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact the Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., MS–D74, Atlanta, 

Georgia 30329; phone: 404–639–7570; 

Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited 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) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (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; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

Promotion of the National 

Amyotrophic Lateral Sclerosis (ALS) 

Registry to Non-referral Centers—New— 

Agency for Toxic Substances and 

Disease Registry, Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Agency for Toxic Substances and 

Disease Registry (ATSDR) is requesting 

a two-year Office of Management and 

Budget (OMB) information collection 

clearance for the project entitled 

‘‘Promotion of the National ALS 

Registry to Non-referral Centers’’. 

ATSDR is authorized by the Public 

Health Law No: 110–373, ALS Registry 

Act to (1) develop a system to collect 

data on amyotrophic lateral sclerosis 

(ALS) and other motor neuron disorders 

that can be confused with ALS, 

misdiagnosed as ALS, or progress to 

ALS; and (2) establish a national registry 

for the collection and storage of such 

data to develop a population-based 

registry of cases. 

The primary goal of the National ALS 

surveillance system/registry is to obtain 

more complete information on the likely 

prevalence of ALS and to better describe 

the demographic characteristics (age, 

race, sex, and geographic location) of 

those with ALS. The secondary goal of 

the registry is to collect additional 

information on potential risk factors for 

ALS including, but not limited to, 

family history of ALS, smoking history, 

and military service. The proposed 

project is a new component to be added 

to the existing Registry and ALS 

Surveillance Projects to increase selfenrollment rates of those with ALS. 

ATSDR implemented the National 

ALS Registry (Registry) in 2009 using an 

algorithm applied to national 

administrative databases. A selfregistration component was launched in 

October 2010. The Registry’s case 

ascertainment methodology required 

validation; therefore, ATSDR 

established State and Metropolitan ALS 

Surveillance Projects (Surveillance 

Projects). In order to avoid biasing 

results from the Surveillance Projects’ 

evaluation of the Registry’s 

completeness, staff received instruction 

to not promote the Registry during the 

surveillance period. 

According to the Morbidity and 

Mortality Weekly Report (MMWR) 

published in 2014, the proportion of 

cases identified via self-registration was 

lower than those identified in the 

administrative data for the period 

October 2010–December 2011. On-going 

self-registration is critical because not 

all persons with ALS can be identified 

through the algorithm, and only selfregistering persons with ALS can 

complete the risk-factor surveys. 

Therefore, efforts to increase Registry 

awareness among non-referral center 

neurology practices/neurologists is 

needed to increase self-enrollment of 

persons with ALS. 

This new information collection 

request is a result of the need to 

promote the Registry among 

neurologists who do not work at major 

ALS referral centers. The following 

objectives are set for this project: 

• To implement a pilot project to 

conduct educational and promotional 

outreach activities at non-referral center 

neurology practices in the U.S., to 

inform neurologists and their staff about 

the Registry; 

• To encourage neurologists to inform 

their patients about the Registry, and to 

increase persons with ALS selfenrollment in the Registry through the 

web portal via the use of existing 

Registry brochures, pamphlets, and 

factsheets; and 

• To examine the effectiveness of 

educational and promotional outreach 

activities by reviewing persons with 

ALS self-enrollment rates before, 

during, and after the project period. 

The increase in self-enrollment rates 

will allow ATSDR to produce more 

accurate estimates of prevalence of ALS, 

and collect risk-factor survey data from 

a more representative sample of persons 

with ALS nationwide. Additionally, 

self-enrollment of people with ALS 

provides them with opportunities to be 

informed about the disease risk factors, 

learn more about beneficial therapies 

and a cure for the disease. In due 

course, these activities will also allow 

ATSDR to fulfill its congressional 

mandate under the ALS Registry Act. 

To achieve the above mentioned 

objectives, a four group educational and 

promotional outreach study has been 

designed. Three groups (Group 1, Group 

2 and Group 3), with two states in each 

group, will receive various educational 

and promotional components, and a 

fourth group (Group 4) consisting of the 

remaining 44 states, will serve as a 

comparison (will not receive any 

intervention). This project will 

implement a methodology similar to 

that used during previous ALS 

Surveillance Projects to identify all nonreferral center neurologists in Groups 1, 

2, and 3. Neurologists who do or would 

diagnose and/or care for ALS patients in 

Groups 1 and 2 and all neurologists in 

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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