72692 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Regulation citation Form name Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

§ 60.11: Reporting negative actions or 

findings taken by peer review organizations or private accreditation entities.

Peer Review Organization ..................

Accreditation .......................................

10 

12 

1 

1 

10 

12 

.75 

.75 

8 

9 

§ 60.12: Reporting adverse actions 

taken against clinical privileges.

Title IV Clinical Privileges Actions ......

Professional Society ...........................

671 

50 

1 

1 

671 

50 

.75 

.75 

503 

38 

§ 60.13: Reporting Federal or State 

criminal convictions related to the 

delivery of a health care item or 

service.

Criminal Conviction (Guilty Plea or 

Trial) (manual).

Criminal Conviction (Guilty Plea or 

Trial) (automated).

1,308 

937 

1 

1 

1,308 

937 

.75 

.0003 

981 

.3 

Deferred Conviction or Pre-Trial Diversion.50 1 50 .75 38 

Nolo Contendere (No Contest) Plea ... 80 1 80 .75 60 

Injunction ............................................. 10 1 10 .75 8 

§ 60.14: Reporting civil judgments related to the delivery of a health care 

item or service.

Civil Judgment .................................... 14 1 14 .75 11 

§ 60.15: Reporting exclusions from 

participation in Federal or State 

health care programs.

Exclusion/Debarment (manual) ...........

Exclusion/Debarment (automated) .....

1,185 

5,094 

1 

1 

1,185 

5,094 

.75 

.0003 

889 

2 

§ 60.16: Reporting other adjudicated 

actions or decisions.

Government Administrative .................

Health Plan Action ..............................

2,233 

524 

1 

1 

2,233 

524 

.75 

.75 

1,675 

393 

§ 60.18 Requesting Information from 

the NPDB.

One Time Query for an Individual 

(manual).

1,980,825 1 1,980,825 .08 158,466 

One Time Query for an Individual 

(automated).

2,163,208 1 2,163,208 .0003 649 

One Time Query for an Organization 

(manual).

39,920 1 39,920 .08 3,194 

One Time Query for an Organization 

(automated).

2,266 1 2,266 .0003 1 

Self-Query on an Individual ................ 77,318 1 77,318 .42 30,201 

Self-Query on an Organization ........... 427 1 427 .42 167 

Continuous Query (manual) ................ 508,203 1 508,203 .08 40,656 

Continuous Query (automated) .......... 121,718 1 121,718 .0003 37 

§ 60.21: How to dispute the accuracy 

of NPDB information.

Subject Statement and Dispute ..........

Request for Dispute Resolution ..........

3,501 

94 

1 

1 

3,501 

94 

.75 

8 

2,626 

752 

Administrative ...................................... Non-Hospital Entity Registration (Initial).524 1 524 1 524 

Non-Hospital Entity Registration (Renewal & Update).6,383 1 6,383 .25 1,596 

Hospital Registration (Initial) ............... 37 1 37 1 37 

Hospital Registration (Renewal & Update).3,198 1 3,198 .25 800 

Licensing Board Data Request ........... 140 1 140 10.5 1,470 

Reporting Entity Discrepancy Letter ... 389 1 389 4 1556 

Licensing Board Attestation ................ 354 1 354 1 354 

Corrective Action Plan ........................ 10 1 10 .08 1 

Reconciling Missing Actions ............... 2,176 1 2,176 .08 174 

Agent Registration (Initial) .................. 30 1 30 1 30 

Agent Registration (Renewal & Update).194 1 194 .08 16 

Electronic Transfer of Funds (EFT) 

Authorization.

566 1 566 .08 45 

Authorized Agent Designation ............ 788 1 788 .25 197 

Account Discrepancy .......................... 41 1 41 .25 10 

Total ............................................. ............................................................. 5,009,324 ........................ 5,009,324 ........................ 275,429 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–28650 Filed 12–5–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Expert Panel Meeting on Identifying 

Research Needs for Assessing Safe 

Use of High Intakes of Folic Acid; 

Notice of Public Meeting and 

Registration Information 

SUMMARY: The National Toxicology 

Program (NTP) and the Office of Dietary 

Supplements (ODS) announce a public 

expert panel meeting on May 11–12, 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices 72693 

2015, to identify research needs based 

on the state of the science related to the 

safe use of high intakes of folic acid. 

The expert panel meeting is open to the 

public. Registration is requested for 

public attendance, in-person or via the 

webcast, and for oral comment. 

Information about the meeting and 

registration are available at http://ntp.

niehs.nih.gov/go/730864. 

DATES: 

Meeting: May 11–12, 2015, 8:30 a.m. 

Eastern Daylight Time to approximately 

5 p.m. on May 11 and approximately 

12:00 p.m. on May 12. 

Document Availability: The literature 

review document should be available by 

April 6, 2015, and will be posted to 

http://ntp.niehs.nih.gov/go/730864 

when available. 

Written Public Comment Submission 

and Registration for Oral Comments: 

Deadline is May 4, 2015. 

Registration for Accommodation: 

Deadline is May 4, 2015, for individuals 

with disabilities who need 

accommodation to participate. 

ADDRESSES: 

Meeting Location: Natcher Conference 

Center (Building 45), National Institutes 

of Health, Bethesda, MD 20892. 

Meeting Web page: The preliminary 

agenda, registration, roster, literature 

review document, and other meeting 

materials will be posted to http://ntp.

niehs.nih.gov/go/730864 when 

available. 

Webcast: The URL for viewing the 

webcast will be provided to those who 

register. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Yun Xie, NTP Designated Federal 

Official, Office of Liaison, Policy and 

Review, DNTP, NIEHS, P.O. Box 12233, 

MD K2–03, Research Triangle Park, NC 

27709. Phone: (919) 541–3436, Fax: 

(301) 451–5455, Email: yun.xie@nih.gov. 

Hand Delivery/Courier: 530 Davis Drive, 

Room 2161, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Meeting and Registration: The 

meeting is open to the public with time 

set aside for oral public comment; 

attendance at NIH is limited only by the 

space available. Registration is 

recommended for in-person attendance 

to ensure space and to view the webcast; 

the URL for the webcast will be 

provided in the email confirming 

registration. Individuals who plan to 

provide oral comments (see below) are 

encouraged to register online by May 4, 

2015, at http://ntp.niehs.nih.gov/go/

730864. Individuals interested in this 

meeting are encouraged to access the 

Web site to stay abreast of the most 

current information regarding the 

meeting. Visitor and security 

information for those attending inperson is available at http://

www.nih.gov/about/visitor/. Individuals 

with disabilities who need 

accommodation to participate in this 

event should contact Dr. Yun Xie at 

phone: (919) 541–3436 or email: 

yun.xie@nih.gov. TTY users should 

contact the Federal TTY Relay Service 

at (800) 877–8339. Requests should be 

made at least five business days in 

advance of the event. 

Background Information on Folic 

Acid and Reason for the Evaluation: 

Humans require folate, a water-soluble 

B-complex vitamin, for everyday growth 

and cell division and for critical periods 

of rapid growth and cell division such 

as embryonic development. Thus, folate 

is necessary for all individuals, but is 

especially important for women who 

may become pregnant. At the same time, 

there is interest in understanding 

potential adverse health impacts from 

high intakes of folic acid, the form of 

folate commonly added to foods and 

dietary supplements. 

Folate is present in the diet through 

its natural occurrence in food, as a food 

additive, and as an ingredient in dietary 

supplements. Naturally occurring folate 

is unlikely to be associated with 

potential adverse effects because it has 

lower bioavailability than folic acid and 

its consumption is also limited by the 

bulk and caloric content of foods. 

Therefore, the primary substance of 

interest for considering the safety of 

high intake is folic acid. 

Evaluating the potential for adverse 

health effects associated with high folic 

acid intakes has been challenging 

because of the lack of systematic studies 

and other sources of evidence on this 

topic. In 1998, the Food and Nutrition 

Board of the Institute of Medicine set 

Dietary Reference Intakes that included 

the Recommended Dietary Allowances 

(RDAs) and tolerable upper intake levels 

(ULs)—the highest level of daily intake 

likely to pose no risk of adverse health 

effects to almost all of the population— 

for folic acid and other B vitamins. The 

folic acid UL (1000 mg) was established 

with the paucity of data available to the 

committee at the time; i.e., limited, 

suggestive evidence that excessive folate 

intake may precipitate or exacerbate 

neuropathy in vitamin B12-deficient 

individuals. Since this 1998 publication 

that set the UL for folic acid, many 

publications have reported on health 

effects over a range of folic acid intakes. 

Some studies have raised concerns that 

high intake of folic acid may be 

associated with potential adverse health 

effects. 

Expert Panel Meeting: The NTP and 

ODS are convening an expert panel to 

identify research needs related to the 

safe use of high intakes of folic acid 

based on consideration of the state of 

the science. The expert panel meeting 

will bring together experts from 

multiple disciplines including, but not 

limited to, epidemiology, nutrition, 

medicine, and toxicology. In 

preparation for this evaluation, 

screening of the literature was 

undertaken to identify potential adverse 

health effects for which further research 

might be warranted. A literature review 

document is being prepared on four 

health outcome areas using systematic 

review methodology: (1) Cancer, (2) 

cognition in conjunction with vitamin 

B12, (3) hypersensitivity-related 

outcomes, and (4) endocrine and 

metabolic outcomes. The literature 

review document should be available by 

April 6, 2015, and will be posted to 

http://ntp.niehs.nih.gov/go/730864. A 

document describing the approach for 

conducting the literature evaluation has 

also been prepared and is posted on the 

NTP Web site (http://ntp.niehs.nih.gov/ 

ntp/ohat/folicacid/ntpfolicacid_

approach_508.pdf). This document 

describing the approach includes 

information on the dose levels of folic 

acid being considered for the 

evaluation. 

Request for Comments: The deadline 

for submission of written comments is 

May 4, 2015, to enable review by the 

expert panel and NTP and ODS staff 

prior to the meeting. Registration to 

provide oral comments is by May 4, 

2015, at http://ntp.niehs.nih.gov/go/

730864. Public comments and any other 

correspondence should be sent to the 

FOR FURTHER INFORMATION CONTACT. 

Persons submitting written comments 

should include their name, affiliation, 

mailing address, phone, email, and 

sponsoring organization (if any) with 

the document. Written comments 

received in response to this notice will 

be posted on the NTP Web site, and the 

submitter will be identified by name, 

affiliation, and/or sponsoring 

organization. 

Public comment at this meeting is 

welcome, with time set aside for the 

presentation of oral comments on the 

agenda topics. In addition to in-person 

oral comments at the NIH, public 

comments can be presented by 

teleconference line. There will be 50 

lines for this call; availability is on a 

first-come, first-served basis. Oral 

comments will be received only during 

the formal public comment periods 

indicated on the preliminary agenda. 

The access number for the 

teleconference line will be provided to 

registrants by email prior to the meeting. 

Each affiliation or sponsoring 

mstockstill on DSK4VPTVN1PROD with NOTICES

72694 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices 

organization is allowed one time slot. At 

least 7 minutes will be allotted to each 

time slot, and if time permits, may be 

extended to 10 minutes at the discretion 

of the chair. 

Persons wishing to make an oral 

presentation are asked to register online 

at http://ntp.niehs.nih.gov/go/730864 by 

May 4, 2015, and indicate whether they 

will present comments in-person or via 

the teleconference line. If possible, oral 

public commenters should send a copy 

of their slides and/or statement or 

talking points at that time. Written 

statements can supplement and may 

expand the oral presentation. 

Registration for in-person oral 

comments will also be available at the 

meeting, although time allowed for 

presentation by on-site registrants may 

be less than that for registered speakers 

and will be determined by the number 

of speakers who register on-site. 

Background Information on NTP and 

ODS: The NTP is an interagency 

program, established in 1978 (43 FR 

53060) and headquartered at the 

National Institute of Environmental 

Health Sciences (NIEHS) of the National 

Institutes of Health (NIH). The mission 

of NTP is to evaluate agents of public 

health concern by developing and 

applying tools of modern toxicology and 

molecular biology. The NTP carries out 

literature analysis activities in the Office 

of Health Assessment and Translation 

and the Office of the Reports on 

Carcinogens. The NTP also designs and 

conducts laboratory studies and testing 

programs and analyzes its findings to 

assess potential hazards to human 

health from exposure to environmental 

substances, including dietary 

supplements (see http://ntp.niehs.nih.

gov/). 

The mission of the ODS of the NIH is 

to strengthen knowledge and 

understanding of dietary supplements 

by evaluating scientific information, 

stimulating and supporting research, 

disseminating research results, and 

educating the public to foster an 

enhanced quality of life and health for 

the population of the United States. The 

purpose and responsibilities of the ODS 

are to explore more fully the potential 

role of dietary supplements as a 

significant part of the efforts of the 

United States to improve health care; to 

promote scientific study of the benefits 

of dietary supplements in maintaining 

health and preventing chronic disease 

and other health-related conditions; to 

conduct and coordinate scientific 

research within NIH relating to dietary 

supplements; to collect and compile the 

results of scientific research relating to 

dietary supplements, including 

scientific data from foreign sources; and 

to serve as the principal advisor to the 

Secretary of the Department of Health 

and Human Services and the Assistant 

Secretary for Health and to provide 

advice on issues relating to dietary 

supplements to the Director of NIH, the 

Director of the Centers for Disease 

Control and Prevention, and the 

Commissioner of the Food and Drug 

Administration (see http://ods.od.nih.

gov/). The Dietary Supplement Health 

and Education Act of 1994 (Pub. L. 103– 

417, DSHEA) authorized the 

establishment of the ODS at the NIH in 

1995. 

Background Information on NTP 

Expert Panels: NTP panels are technical, 

scientific advisory bodies established on 

an ‘‘as needed’’ basis to provide 

independent scientific peer review and 

advise the NTP on agents of public 

health concern, new/revised 

toxicological test methods, or other 

issues. These panels help ensure 

transparent, unbiased, and scientifically 

rigorous input to the program for its use 

in making credible decisions about 

human hazard, setting research and 

testing priorities, and providing 

information to regulatory agencies about 

alternative methods for toxicity 

screening. The NTP welcomes 

nominations of scientific experts for 

upcoming panels. Scientists interested 

in serving on an NTP panel should 

provide current curriculum vitae to the 

FOR FURTHER INFORMATION CONTACT. The 

authority for NTP panels is provided by 

42 U.S.C. 217a; section 222 of the Public 

Health Service (PHS) Act, as amended. 

The panel is governed by the Federal 

Advisory Committee Act, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory committees. 

Dated: December 2, 2014. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2014–28681 Filed 12–5–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Deafness and Other 

Communication Disorders Advisory 

Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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 Deafness and 

Other Communication Disorders Advisory 

Council. 

Date: January 30, 2015. 

Closed: 8:30 a.m. to 10:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Open: 10:00 a.m. to 2:00 p.m. 

Agenda: Staff reports on divisional, 

programmatic, and special activities. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Craig A. Jordan, Ph.D., 

Director, Division of Extramural Activities, 

NIDCD, NIH, Room 8345, MSC 9670, 6001 

Executive Blvd., Bethesda, MD 20892–9670, 

301–496–8693, jordanc@nidcd.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcd.nih.gov/about/Pages/AdvisoryGroups-and-Review-Committees.aspx, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

mstockstill on DSK4VPTVN1PROD with NOTICES