Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 15797 

program outcomes. The evaluation is 

used to determine how participants’ 

quality of life changes after transitioning 

to the community. The semi-annual 

progress report is used by the national 

evaluation contractor and CMS to 

monitor program implementation at the 

grantee level. Form Number: CMS– 

10249 (OMB control number: 0938– 

1053); Frequency: Yearly, quarterly, and 

semi-annually; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 45; Total Annual 

Responses: 28,590; Total Annual Hours: 

14,225. (For policy questions regarding 

this collection contact Michael Smith at 

410–786–2267.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Outcome and 

Assessment Information Set (OASIS) 

OASIS–C1/ICD–10; Use: Home health 

agencies (HHAs) are required to collect 

the outcome and assessment 

information data set (OASIS) to 

participate in the Medicare program. We 

are requesting a new OMB control 

number for the proposed revised OASIS 

item set, referred to hereafter as OASIS– 

C1/ICD–10. The current version of the 

OASIS–C1/ICD–9 data set was approved 

by OMB on October 7, 2014 (0938– 

0760), and will be in use until the 

implementation of the ICD–10 coding 

system which is currently scheduled for 

October 1, 2015. Subsequent to the 60- 

day Federal Register notice (80 FR 

1419), there was a minor typographical 

correction made to the data set. Form 

Number: CMS–10545 (OMB control 

number: 0938–NEW); Frequency: 

Occasionally; Affected Public: Private 

Sector (Business or other for-profit and 

Not-for-profit institutions); Number of 

Respondents: 12,014; Total Annual 

Responses: 17,268,890; Total Annual 

Hours: 15,320,253. (For policy questions 

regarding this collection contact Cheryl 

Wiseman at 410–786–1175). 

Dated: March 17, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–06884 Filed 3–20–15; 5:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Ninth Annual Drug Information 

Association/Food and Drug 

Administration Statistics Forum— 

2015; Public Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration (FDA), in cosponsorship 

with the Drug Information Association 

(DIA), is announcing a public 

conference entitled ‘‘Ninth Annual DIA/ 

FDA Statistics Forum—2015’’. The 

purpose of the conference is to discuss 

relevant statistical issues associated 

with the development and review of 

therapeutic drugs and biologics. A 

primary focus for this meeting will be to 

establish an ongoing dialogue regarding 

FDA’s ‘‘Critical Path’’ initiative— 

emphasizing the regulatory and 

statistical challenges associated with 

innovative approaches to the design and 

analysis of clinical trial data and 

measuring the progress being made in 

designing and implementing innovative 

solutions. 

DATES: The public conference will be 

held from April 20, 2015, to April 22, 

2015, from 8:30 a.m. to 5 p.m. each day. 

ADDRESSES: The public conference will 

be held at the Marriott Bethesda North 

Hotel and Conference Center, 5701 

Marinelli Rd., North Bethesda, MD 

20852, 301–822–9200. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Diegel, Drug Information 

Association, 800 Enterprise Rd., 

Horsham, PA 19044, 215–442–6100, 

Ellen.Diegel@diahome.org; or Stephen 

Wilson, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 21, 

Rm. 3630, Silver Spring, MD 20993– 

0002, 301–796–0579, Stephen.Wilson@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This annual FDA/DIA statistics forum 

will be a unique, open, international 

forum for statisticians and clinicians 

from industry, academia, contract 

research organizations, and Government 

Agencies. Meeting participants will 

learn, discuss, and collaborate on the 

current and emerging statistical 

methodologies and quantitative 

approaches used by sponsors to provide 

evidence for the approval of new 

therapies. 

The goals of the program are to: 

• Explore and implement innovative 

statistical solutions to issues associated 

with the regulatory review of 

therapeutic drugs and biologics. 

• Describe the application of 

statistical methodologies and thinking 

to the development of new therapeutic 

biologics and drugs. 

• Assess the impact of regulations 

and guidance on statistical practice. 

• Discuss ideas for improving the 

communication between industry 

statisticians and FDA reviewers. 

A description of the planned activities 

of the working groups can be found at 

http://www.diahome.org/en-US/

Meetings-and-Training/Find-Meetingsand-Training/MeetingDetails.aspx?ProductID=

3630578&EventType=Meeting. 

II. Registration and Accommodations 

A. Registration 

To register, please submit the 

registration form online at http://

www.diahome.org/en-US/Meetings-andTraining/Find-Meetings-and-Training/

Meeting-Details.aspx?ProductID=

3630578&EventType=Meeting. (FDA has 

verified this Web site address but is not 

responsible for changes to the Web site 

after this document publishes in the 

Federal Register.) Seats are limited, and 

conference space will be filled in the 

order in which registrations are 

received. On-site registration will be 

available to the extent that space is 

available on the day of the conference. 

The costs of registration for different 

categories of attendees are as follows: 

Category Cost 

Industry Representatives ...... $1,440 

Charitable Nonprofit/Academic (Full time) ............... 720 

Government (Full time) ......... 430 

Tutorial Fees ......................... 405 

All registrants will be required to pay 

the applicable fee, with the exception of 

a limited number of speakers/organizers 

who will have a complimentary 

registration. (Government and nonprofit 

attendees and exhibitors will need an 

invitation code to register at the 

discounted rate. An invitation code can 

be obtained by sending an email to 

Ellen.Diegel@diahome.org.) Registration 

fees cover the costs of facilities, 

materials, and food functions. 

B. Accommodations 

Attendees are responsible for their 

own accommodations. Reservations may 

be made online via the conference hotel 

reservation page at https://

www.tphousing.com/ph2/


rljohnson on DSK3VPTVN1PROD with NOTICES
15798 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 

startres.aspx?EICode=3132&

Attcode=72. 

The Marriott Bethesda North Hotel 

and Conference Center has a limited 

number of rooms available at the 

discounted rate of $199 per night until 

April 3, 2015, or until the block is filled. 

To receive this rate, attendees are asked 

to make reservations using the link to 

the hotel reservation page or by calling 

855–355–0302 or 212–532–1660. If 

calling, please select the first option for 

‘‘Hotel Reservations’’ and inform the 

phone agent that you are making a 

reservation for ‘‘Event #15008’’. 

If you need special accommodations 

because of disability, please contact 

Ellen.Diegel@diahome.org at least 7 

days before the meeting. 

Dated: March 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06702 Filed 3–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

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 meeting. 

The meeting 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 Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Epilepsy Clinical Trial 

Review. 

Date: April 22, 2015. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: William C. Benzing, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

NINDS/NIH/DHHS/Neuroscience Center, 

6001 Executive Boulevard, Suite 3208, MSC 

9529, Bethesda, MD 20892–9529, 301–496– 

0660, benzingw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: March 19, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–06841 Filed 3–24–15; 8:45 am] 

BILLING CODE 4140–01–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 Using Longitudinal Data to 

Characterize the Natural History of 

Fragile X Syndrome to Improve Services 

and Outcomes, DD15–003, 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.–6:00 p.m., April 

14, 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 ‘‘Using Longitudinal Data to 

Characterize the Natural History of Fragile X 

Syndrome to Improve Services and 

Outcomes, DD15–003, initial review.’’ 

Contact Person for More Information: M. 

Chris Langub, Ph.D., Scientific Review 

Officer, CDC, 4770 Buford Highway NE., 

Mailstop F–80, Atlanta, Georgia 30341, 

Telephone: (770) 488–3585, EEO6@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. 

Catherine Ramadei, 

Acting Director, Management Analysis and 

Services Office Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–06849 Filed 3–24–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 Institute of 

Allergy and Infectious Diseases, Special 

Emphasis Panel; Loan Repayment Program 

(LRP). 

Date: April 20–24, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892, (Virtual 

Meeting). 

Contact Person: Maryam Feili-Hariri, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institutes of Health/

NIAID, 5601 Fishers Lane, Rockville, MD 

20852, 240–669–5026, haririmf@

niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases, Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: April 20, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3F100, 5601 Fishers Lane, Rockville, MD 

20852, (Telephone Conference Call). 

Contact Person: Jane K. Battles, Ph.D., 

Scientific Review Officer, Scientific Review 

Program DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, Rockville, MD 20852, 240–669– 

5029, battlesja@mail.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases, Special 

Emphasis Panel; NIAID Peer Review Meeting. 

Date: April 23, 2015. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Betty Poon, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 


rljohnson on DSK3VPTVN1PROD with NOTICES