Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22329 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

William T. Flynn, Center for Veterinary 

Medicine (HVF–1), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9084, 

William.flynn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This document is related to two 

documents published elsewhere in this 

issue of the Federal Register, wherein 

FDA is announcing: (1) The availability 

of a draft guidance entitled ‘‘New 

Animal Drugs and New Animal Drug 

Combination Products Administered in 

or on Medicated Feed or Drinking Water 

of Food-Producing Animals: 

Recommendations for Drug Sponsors for 

Voluntarily Aligning Product Use 

Conditions With GFI #209’’ (draft GFI 

#213); and (2) the availability of a draft 

proposed regulation for veterinary feed 

directives. 

In the Federal Register of June 29, 

2010 (75 FR 37450), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘The Judicious Use of 

Medically Important Antimicrobial 

Drugs in Food-Producing Animals,’’ 

giving interested persons until August 

30, 2010, to comment on the draft 

guidance. FDA received numerous 

comments on the draft guidance, and 

those comments were considered as the 

guidance was finalized. Minor editorial 

changes were made to improve clarity. 

The Agency was pleased to receive a 

number of comments that were 

generally supportive of the concepts 

outlined in draft GFI #209. However, 

other comments were more critical, 

based largely on the guidance’s lack of 

specificity related to implementation 

issues. FDA decided not to make any 

substantive changes to GFI #209 but 

rather to address specific issues related 

to implementation through issuance of a 

separate draft guidance document, draft 

GFI #213, that would afford additional 

opportunity for public comment. As 

noted earlier, a notice of availability for 

draft GFI #213 is published elsewhere in 

this issue of the Federal Register. 

The guidance announced in this 

notice finalizes the draft guidance dated 

June 28, 2010. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the 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. 

III. Paperwork Reduction Act of 1995 

FDA concludes that there are no 

collections of information under the 

Paperwork Reduction Act of 1995. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8846 Filed 4–11–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Recruitment of Sites for Assignment of 

Corps Personnel Obligated Under the 

National Health Service Corps 

Scholarship Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: General notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

announces that the listing of entities, 

and their Health Professional Shortage 

Area (HPSA) scores, that will receive 

priority for the assignment of National 

Health Service Corps (NHSC) 

scholarship recipients (Corps Personnel, 

Corps members) during the period July 

1, 2012, through June 30, 2013, is posted 

on the NHSC Web site at http:// 

datawarehouse.hrsa.gov/HGDWReports/ 

OneClickRptFilter.

aspx?rptName=NHSCApp

SiteList&rptFormat=HTML3.2. This 

searchable database specifies all 

currently approved NHSC service sites, 

by State, and can be utilized to 

determine which entities are eligible to 

receive assignment of Corps members 

who are participating in the NHSC 

Scholarship Program based on the 

threshold HPSA score set forth below. 

Please note that entities on this list may 

or may not have current job 

opportunities for NHSC scholars. 

Furthermore, not all vacancies 

associated with sites on the list 

described below will be for Corps 

members, but could be for NHSC 

Scholarship Program participants 

serving their obligation through the 

Private Practice Option. 

Eligible HPSAs and Entities 

To be eligible to receive assignment of 

Corps personnel, entities must: (1) Have 

a current HPSA designation by the 

Office of Shortage Designation, Bureau 

of Health Professions, HRSA; (2) not 

deny requested health care services, or 

discriminate in the provision of services 

to an individual because the individual 

is unable to pay for the services or 

because payment for the services would 

be made under Medicare, Medicaid, or 

the Children’s Health Insurance 

Program (CHIP); (3) enter into an 

agreement with the State agency that 

administers Medicaid and CHIP, accept 

assignment under Medicare, see all 

patients regardless of their ability to pay 

and post such policy, and use and post 

a discounted fee plan; and (4) be 

determined by the Secretary to have: 

(a) A need and demand for health 

manpower in the area; (b) appropriately 

and efficiently used Corps members 

assigned to the entity in the past; (c) 

general community support for the 

assignment of Corps members; (d) made 

unsuccessful efforts to recruit; (e) a 

reasonable prospect for sound fiscal 

management by the entity with respect 

to Corps members assigned there; and (f) 

demonstrated a willingness to support 

and facilitate mentorship, professional 

development, and training opportunities 

for Corps members. 

Priority in approving applications for 

assignment of Corps members goes to 

sites that (1) provide primary medical 

care, mental health, and/or oral health 

services to a primary medical care, 

mental health, or dental HPSA of 

greatest shortage, respectively; (2) are 

part of a system of care that provides a 

continuum of services, including 

comprehensive primary health care and 

appropriate referrals or arrangements for 

secondary and tertiary care; (3) have a 

documented record of sound fiscal 

management; and (4) will experience a 

negative impact on its capacity to 

provide primary health services if a 


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22330 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

Corps member is not assigned to the 

entity. Sites that provide specialized 

care, or a limited set of services may not 

receive approval as NHSC service sites. 

This may include clinics that focus on 

one disease or disorder or offer limited 

services, such as a clinic that only 

provides immunizations or a substance 

abuse clinic. 

Entities that receive assignment of 

Corps personnel must assure that: (1) 

The position will permit the full scope 

of practice and that the clinician meets 

the credentialing requirements of the 

State and site; and (2) the Corps member 

assigned to the entity is engaged in the 

requisite amount of clinical practice, as 

defined below, to meet his or her service 

obligation: 

Full-Time Clinical Practice 

‘‘Full-time clinical practice’’ is defined as 

a minimum of 40 hours per week for at least 

45 weeks per service year. The 40 hours per 

week may be compressed into no less than 

4 work days per week, with no more than 12 

hours of work to be performed in any 24-hour 

period. Time spent on-call does not count 

toward the full-time service obligation, 

except to the extent the provider is directly 

treating patients during that period. 

For all health professionals, except as 

noted below, at least 32 of the minimum 40 

hours per week must be spent providing 

direct patient care or teaching in the 

outpatient ambulatory care setting(s) at the 

NHSC-approved service site(s) during 

normally scheduled office hours. The 

remaining 8 hours per week must be spent 

providing clinical services for patients or 

teaching in the approved practice site(s), 

providing clinical services in alternative 

settings as directed by the approved practice 

site(s), or performing practice-related 

administrative activities. Teaching activities 

at the approved service site shall not exceed 

8 hours of the minimum 40 hours per week, 

unless the teaching takes place in a HRSAfunded Teaching Health Center (see Sec. 

340H of the U.S. Public Health Service Act, 

42 United States Code Sec. 256h). Teaching 

activities in a HRSA-funded Teaching Health 

Center shall not exceed 20 hours of the 

minimum 40 hours per week. 

For obstetrician/gynecologists, certified 

nurse midwives (CNMs), family medicine 

physicians who practice obstetrics on a 

regular basis, providers of geriatric services, 

pediatric dentists, and behavioral/mental 

health providers, at least 21 of the minimum 

40 hours per week must be spent providing 

direct patient care or teaching in the 

outpatient ambulatory care setting(s) at the 

NHSC-approved service site(s), during 

normally scheduled office hours. The 

remaining 19 hours per week must be spent 

providing clinical services for patients or 

teaching in the approved practice site(s), 

providing clinical services in alternative 

settings as directed by the approved practice 

site(s), or performing practice-related 

administrative activities. No more than 8 

hours per week can be spent performing 

practice-related administrative activities. 

Teaching activities at the approved service 

site shall not exceed 8 hours of the minimum 

40 hours per week, unless the teaching takes 

place in a HRSA-funded Teaching Health 

Center. Teaching activities in a HRSA-funded 

Teaching Health Center shall not exceed 20 

hours of the minimum 40 hours per week. 

For physicians (including psychiatrists), 

physician assistants, nurse practitioners 

(including those specializing in psychiatry or 

mental health), and certified nurse midwives 

serving in a Critical Access Hospital (CAH)— 

defined as a nonprofit facility that is: (a) 

Located in a State that has established with 

the Centers for Medicare and Medicaid 

Services (CMS) a Medicare rural hospital 

flexibility program; (b) designated by the 

State as a CAH; (c) certified by the CMS as 

a CAH; and (d) in compliance with all 

applicable CAH conditions of participation— 

at least 16 of the minimum 40 hours per 

week must be spent providing direct patient 

care or teaching in the CAH-affiliated 

outpatient ambulatory care setting(s) 

specified in the NHSC’s Customer Service 

Portal, during normally scheduled office 

hours. The remaining 24 hours of the 

minimum 40 hours per week must be spent 

providing direct patient care for patients or 

teaching at the CAH(s) or the CAH-affiliated 

outpatient ambulatory care setting specified 

in the Customer Service Portal, providing 

direct patient care in the CAH’s skilled 

nursing facility or swing bed unit, or 

performing practice-related administrative 

activities. No more than 8 hours per week 

can be spent on practice-related 

administrative activities. Teaching activities 

at the approved service site(s) shall not 

exceed 8 hours of the minimum 40 hours per 

week, unless the teaching takes place in a 

HRSA-funded Teaching Health Center (THC) 

(see Sec. 340H of the U.S. Public Health 

Service Act, 42 United States Code Sec. 

256h). Teaching activities in a HRSA-funded 

THC shall not exceed 20 hours of the 

minimum 40 hours per week. 

Half-Time Clinical Practice 

‘‘Half-time clinical practice’’ is defined as 

a minimum of 20 hours per week (not to 

exceed 39 hours per week), for at least 45 

weeks per service year. The 20 hours per 

week may be compressed into no less than 

2 work days per week, with no more than 12 

hours of work to be performed in any 24-hour 

period. Time spent on-call does not count 

toward the half-time service obligation, 

except to the extent the provider is directly 

serving patients during that period. 

For all health professionals, except as 

noted below, at least 16 of the minimum 20 

hours per week must be spent providing 

direct patient care in the outpatient 

ambulatory care setting(s) at the NHSCapproved service site(s), during normally 

scheduled office hours. The remaining 4 

hours per week must be spent providing 

clinical services for patients or teaching in 

the approved practice site(s), providing 

clinical services in alternative settings as 

directed by the approved practice site(s), or 

performing practice-related administrative 

activities. Teaching and practice-related 

administrative activities shall not exceed a 

total of 4 hours of the minimum 20 hours per 

week. 

For obstetrician/gynecologists, certified 

nurse midwives (CNMs), family medicine 

physicians who practice obstetrics on a 

regular basis, providers of geriatric services, 

pediatric dentists, and behavioral/mental 

health providers, at least 11 of the minimum 

20 hours per week must be spent providing 

direct patient care in the outpatient 

ambulatory care setting(s) at the NHSCapproved service site(s), during normally 

scheduled office hours. The remaining 9 

hours per week must be spent providing 

clinical services for patients or teaching in 

the approved practice site(s), providing 

clinical services in alternative settings as 

directed by the approved practice site(s), or 

performing practice-related administrative 

activities. Teaching and practice-related 

administrative activities shall not exceed 4 

hours of the minimum 20 hours per week. 

For physicians (including psychiatrists), 

physician assistants, nurse practitioners 

(including those specializing in psychiatry or 

mental health), and certified nurse midwives 

serving in a Critical Access Hospital (CAH), 

at least 8 of the minimum 20 hours per week 

must be spent providing direct patient care 

or teaching in the CAH-affiliated outpatient 

ambulatory care setting(s) specified in the 

Customer Service Portal, during normally 

scheduled office hours. The remaining 12 

hours of the minimum 20 hours per week 

must be spent providing direct patient care 

for patients or teaching at the CAH(s) or the 

CAH-affiliated outpatient ambulatory care 

setting specified in the Practice Agreement, 

providing direct patient care in the CAH’s 

skilled nursing facility or swing bed unit, or 

performing practice-related administrative 

activities. Teaching and practice-related 

administrative activities shall not exceed 4 

hours of the minimum 20 hours per week. 

Half-time clinical service is not an option 

for scholars serving their obligation through 

the Private Practice Option. 

In addition to utilizing NHSC assignees in 

accordance with their full-time or half-time 

service obligation (as defined above), sites 

receiving assignment of Corps personnel are 

expected to: (1) Report to the NHSC all 

absences, including those in excess of the 

authorized number of days (up to 35 full-time 

days per service year in the case of full-time 

service and up to 35 half-time days per 

service year in the case of half-time service); 

(2) report to the NHSC any change in the 

status of an NHSC clinician at the site; (3) 

provide the time and leave records, 

schedules, and any related personnel 

documents for NHSC assignees (including 

documentation, if applicable, of the reason(s) 

for the termination of an NHSC clinician’s 

employment at the site prior to his or her 

obligated service end date); and (4) submit an 

NHSC Site Survey, or a Uniform Data System 

(UDS) report in the case of entities receiving 

HRSA grant support under Sec. 330 of the 

Public Health Service Act. The Site Survey 

or UDS report, as applicable, require the site 

to assess the age, sex, race/ethnicity of, and 

provider encounter records for its user 

population and are site specific. Providers 

fulfilling NHSC commitments are assigned to 

a specific site or, in some cases, more than 

one site. The scope of activity to be reported 

in the survey includes all activity at the 


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Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22331 

site(s) to which the Corps member is 

assigned. 

Evaluation and Selection Process 

In order for a site to be eligible for 

placement of NHSC personnel, it must 

be approved by the NHSC following the 

site’s submission of a Site Application. 

The processing of Site Applications 

from solo or group practices may 

involve additional screening, including 

a site visit by NHSC representatives. 

The Site Application approval is good 

for a period of 3 years from the date of 

approval. 

In approving applications for the 

assignment of Corps members, the 

Secretary shall give priority to any such 

application that is made regarding the 

provision of primary health services to 

a HPSA with the greatest shortage. For 

the program year July 1, 2012, through 

June 30, 2013, HPSAs of greatest 

shortage for determination of priority for 

assignment of NHSC scholarshipobligated Corps personnel will be 

defined as follows: (1) Primary medical 

care HPSAs with scores of 16 and above 

are authorized for the assignment of 

NHSC scholarship recipients who are 

primary care physicians, family nurse 

practitioners (NPs), physician assistants 

(PAs) or CNMs; (2) mental health 

HPSAs with scores of 16 and above are 

authorized for the assignment of NHSC 

scholarship recipients who are 

psychiatrists or mental health nurse 

practitioners; and (3) dental HPSAs with 

scores of 16 and above are authorized 

for the assignment of NHSC scholarship 

recipients who are dentists. The NHSC 

has determined that a minimum HPSA 

score of 16 for all eligible clinicians will 

enable it to meet its statutory obligation 

to identify a number of entities eligible 

for placement at least equal to, but not 

greater than, twice the number of NHSC 

scholars available to serve in the 2012– 

2013 placement cycle. 

The number of new NHSC placements 

through the Scholarship Program 

allowed at any one site is limited to one 

(1) of the following provider types: 

Physician (MD/DO), NP, PA, CNM, or 

dentist. The NHSC will consider 

requests for up to two (2) scholar 

placements at any one site on a case-bycase basis. Factors that are taken into 

consideration include community need, 

as measured by demand for services, 

patient outcomes and other similar 

factors, and how the additional scholar 

will impact retention of other clinicians. 

Sites wishing to request an additional 

scholar must complete an Additional 

Scholar Request form available at http://

nhsc.hrsa.gov/scholarship/pdf/ 

additionalscholarrequestform.pdf. 

Sites that do not meet the authorized 

HPSA score threshold indicated above 

may post job openings, however, 

scholars seeking placement between 

July 1, 2012 and June 30, 2013 will be 

advised that they can only compete for 

open positions at sites that meet the 

threshold placement HPSA score of 16. 

While not eligible for scholar 

placements in 2012–2013, vacancies in 

HPSAs scoring less than 16 will be used 

by the NHSC in evaluating the HPSA 

threshold score for the next scholarship 

placement cycle. 

Application Requests, Dates and 

Address 

The list of HPSAs and entities that are 

eligible to receive priority for the 

placement of Corps personnel may be 

updated periodically. Entities that no 

longer meet eligibility criteria, including 

those sites whose 3-year approval as an 

NHSC service site has lapsed or whose 

HPSA designation has been withdrawn 

or proposed for withdrawal, will be 

removed from the priority listing. New 

entities interested in being added to the 

high priority list must submit a Site 

Application to the National Health 

Service Corps by visiting http://

nhsc.hrsa.gov/communities/apply.htm 

to apply online. A searchable database 

of HPSAs and their scores, by State and 

county, is posted at http://

hpsafind.hrsa.gov/. 

Additional Information 

Entities wishing to provide additional 

data and information in support of their 

inclusion on the proposed list of HPSAs 

and entities that would receive priority 

in assignment of scholarship-obligated 

Corps members, must do so in writing 

no later than May 14, 2012. This 

information should be submitted to: 

Sonya Bayone, Chief, Site Branch, 

Division of the National Health Service 

Corps, Bureau of Clinician Recruitment 

and Service, 5600 Fishers Lane, Room 

8–37, Rockville, MD 20857. This 

information will be considered in 

preparing the final list of HPSAs and 

entities that are receiving priority for the 

assignment of scholarship-obligated 

Corps personnel. 

The program is not subject to the 

provisions of Executive Order 12372, 

Intergovernmental Review of Federal 

Programs (as implemented through 45 

CFR Part 100). 

Dated: April 9, 2012. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2012–8928 Filed 4–12–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Solar Cell: A 

Mobile UV Manager for Smart Phones 

Phase II (NCI) 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on January 27, 2012 (77 FR 

4334) and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The 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. 

Proposed Collection: Title: Solar Cell: 

A Mobile UV Manager for Smart Phones 

Phase II (NCI). Type of Information 

Collection Request: New. Need and Use 

of Information Collection: The overall 

goal of the study is to design a smart 

phone application, Solar Cell, which 

uses smart phone technology to aid 

users in protecting their skin from 

damaging ultraviolet radiation (UV) in 

sunlight, a primary cause of skin cancer. 

The purpose of this part of the study is 

to produce, deploy, and evaluate the 

effectiveness of a state-of-the-art 

software application for smart phones 

(i.e., mobile application), ‘‘Solar Cell.’’ 

This software application supports 

decision-making related to sun 

protection and exposure by Americans 

to reduce the risk of developing skin 

cancer attributable to chronic and severe 

UV exposure and developing other 

cancers attributable to vitamin D 

deficiency. The Solar Cell mobile smart 

phone application combines personal 

and behavior data with geo-spatial data 

(i.e., UV Index forecast, time, and 

location) and delivers actionable sun 

protection advice to reduce risk of skin 

cancer. Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Adults (18 and over) from 

the U.S. population who own Android 

smart phones. The annual reporting 

burden is estimated at 308 hours (see 

Table below). There are no Capital 


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