76628 Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices 

Contact Person: Michelle Consolazio, 

Office of the National Coordinator, HHS, 

355 E Street SW., Washington, DC 

20024, 781–710–0786, Fax: 202–690– 

6079, email: 

michelle.consolazio@hhs.gov. Please 

email Michelle Consolazio for up-todate information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. 

Agenda: The committee will hear 

reports from its workgroups and updates 

from ONC and other Federal agencies. 

ONC intends to make background 

material available to the public no later 

than 24 hours prior to the meeting start 

time. If ONC is unable to post the 

background material on its Web site 

prior to the meeting, it will be made 

publicly available at the location of the 

advisory committee meeting, and the 

background material will be posted on 

ONC’s Web site after the meeting, at 

http://www.healthit.gov/FACAS/healthit-standards-committee. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. Written 

submissions may be made to the contact 

person prior to the meeting date. Oral 

comments from the public will be 

scheduled prior to the lunch break and 

at the conclusion of each meeting. Time 

allotted for each presentation will be 

limited to three minutes. If the number 

of speakers requesting to comment is 

greater than can be reasonably 

accommodated during the scheduled 

open public session, ONC will take 

written comments after the meeting. 

Persons attending ONC’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

wireless access or access to electrical 

outlets. 

ONC welcomes the attendance of the 

public at its advisory committee 

meetings. Seating is limited at the 

location, and ONC will make every 

effort to accommodate persons with 

physical disabilities or special needs. If 

special accommodations are required, 

please contact Michelle Consolazio at 

least seven (7) days in advance of the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. No. 92–463, 5 U.S.C., App. 2). 

Dated: December 6, 2013. 

Michelle Consolazio, 

FACA Program Director, Office of Policy and 

Planning, Office of the National Coordinator 

for Health Information Technology. 

[FR Doc. 2013–30102 Filed 12–17–13; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1204] 

Draft Risk Profile on Pathogens and 

Filth in Spices: Availability; Extension 

of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; Extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

notice entitled ‘‘Draft Risk Profile on 

Pathogens and Filth in Spices: 

Availability’’ that appeared in the 

Federal Register of November 4, 2013 

(78 FR 66010). In the notice, FDA 

requested comments that can help 

improve the data and information used; 

the analytical analyses employed; and 

the clarity and transparency of the draft 

risk profile. We are taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments, scientific data, and 

information. 

DATES: We are extending the comment 

period for the draft risk profile. Submit 

either electronic or written comments 

by March 3, 2014. 

ADDRESSES: Submit electronic 

comments and scientific data and 

information to http://

www.regulations.gov. Submit written 

comments and scientific data and 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Jane 

Van Doren, Center for Food Safety and 

Applied Nutrition (HFS–06), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–2927. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

4, 2013 (78 FR 66010), we published a 

notice entitled ‘‘Draft Risk Profile on 

Pathogens and Filth in Spices: 

Availability.’’ The notice provided a 60- 

day comment period for comments that 

can help improve (1) the data and 

information used; (2) the analytical 

analyses employed; and (3) the clarity 

and transparency of the draft risk 

profile. 

We have received one request for an 

extension of the comment period for the 

notice. The request conveyed concern 

that the current 60-day comment period 

is not adequate to develop a response to 

the notice. 

We have considered the request and 

are extending the comment period for 

the notice for 60 days, until March 3, 

2014. We believe that a 60-day 

extension allows adequate time for 

interested persons to submit comments, 

scientific data, and information without 

significantly delaying the risk profile. 

II. Request for 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. 

Dated: December 11, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–30055 Filed 12–17–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0308] 

Centers for Medicare and Medicaid 

Services 

[CMS–3180–N3] 

Pilot Program for Parallel Review of 

Medical Products; Extension of the 

Duration of the Program 

AGENCIES: Food and Drug 

Administration, Centers for Medicare 

and Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) and the Centers 

for Medicare and Medicaid Services 

(CMS) (the Agencies) are announcing 

the extension of the ‘‘Pilot Program for 

Parallel Review of Medical Products.’’ 


ehiers on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices 76629 

The Agencies have decided to continue 

the program as currently designed for an 

additional period of 2 years from the 

date of publication of this notice. 

DATES: This notice is effective December 

18, 2013. 

FOR FURTHER INFORMATION CONTACT: John 

Burke, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5460, Silver Spring, 

MD 20993–0002, 301–796–5738, 

John.Burke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 11, 2011 (76 

FR 62808), the Agencies announced the 

procedures and guiding principles for 

the Parallel Review Pilot Program and 

solicited nominations for the pilot. To 

date, there has been significant interest 

in the pilot and the Agencies are 

currently working through the parallel 

review process with the approved pilot 

program participants. We believe that 

interest in the pilot has also facilitated 

mutually informative discussions 

between additional sponsors and the 

Agencies. 

In the October 11, 2011 (76 FR 62808), 

Parallel Review Pilot Program notice, 

the Agencies stated their intent to 

accept requests for a 2-year period, 

followed by an announcement in the 

Federal Register as to the future of the 

pilot. The Agencies have decided to 

continue the program as currently 

designed for an additional 2 years from 

the date of publication of this notice. 

Once a representative group of 

participants have completed the pilot 

process the Agencies will formally 

evaluate the program for best practices 

and will announce any future revisions 

and/or enhancements in a future 

Federal Register notice. 

Dated: December 5, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: December 6, 2013. 

Margaret A. Hamburg, 

Commissioner of Food and Drugs. 

[FR Doc. 2013–29822 Filed 12–17–13; 8:45 am] 

BILLING CODE 4120–01–M; 4160–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

The National Children’s Study, 

Vanguard (Pilot) Study; Submission for 

OMB Review; 30-Day Comment 

Request 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development (NICHD), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on August 23, 

2013, page 52548 and allowed 60-days 

for public comment. Two public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The Eunice 

Kennedy Shriver, National Institute of 

Child Health and Human Development 

(NICHD), National Institutes of Health, 

may not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: Desk Officer for NIH. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Dr. Sarah L. Glavin, Deputy 

Director, Office of Science Policy, 

Analysis and Communication, Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development, 

National Institutes of Health, 31 Center 

Drive, Room 2A18, Bethesda, Maryland 

20892, or call a non-toll free number 

(301) 496–7898 or Email your request, 

including your address to glavins@

mail.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Proposed Collection: The National 

Children’s Study, Vanguard (Pilot) 

Study, 0925–0593, Expiration 8/31/

2014—Revision, Eunice Kennedy 

Shriver National Institute of Child 

Health and Human Development 

(NICHD), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: The purpose of this request 

is to continue data collection activities 

for the NCS Vanguard Study and receive 

a renewal of the Vanguard Study 

clearance. The NCS also proposes the 

initiation of a new enrollment cohort, 

the addition of new Study visits, 

revisions to existing Study visits, and 

the initiation of methodological 

substudies. The NCS Vanguard Study is 

a prospective, longitudinal pilot study 

of child health and development that 

will inform the design of the Main 

Study of the National Children’s Study. 

Background: The National Children’s 

Study is a prospective, national 

longitudinal study of the interaction 

between environment, genetics on child 

health, and development. The Study 

defines ‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. 

Findings from the Study will be made 

available as the research progresses, 

making potential benefits known to the 

public as soon as possible. The National 

Children’s Study (NCS) has several 

components, including a pilot or 

Vanguard Study, and a Main Study to 

collect exposure and outcome data. 

The NCS Vanguard Study continues 

to follow the children and families 

enrolled in the Vanguard Study, 

conducting Study visits in participants’ 

homes and over the telephone. Data 

Collection visits may include the 

administration of questionnaires, 

neurodevelopmental assessments, 

physical measures, and the collection of 

biospecimens and environmental 

measures. The Vanguard Study has 

yielded valuable data and field 

experience related to participant 

recruitment, the conduct of Study 

assessments, and operational 

requirements associated with NCS 

infrastructure and field efforts. The 

purpose of the proposed data collection 

is to obtain further operational and 

performance data on processes and 

administration Study visit measures. 

Research Questions: The primary 

research goal is to systematically pilot 

additional study visit measures and 

collections for scientific robustness, 

burden to participants and study 

infrastructure, and cost for use in the 

Vanguard (Pilot) Study and to inform 

the Main Study. A secondary goal is to 

increase enrollment in the Vanguard 

Study through the identification of 

subsequent pregnancies among enrolled 

women. 

Methods: The NCS Vanguard Study 

data collection schedule currently 


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