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1) In mountainous terrain or in areas APPENDIX G TO PART 5-CRITERIA FOR b only secondary roads available: 15

THE DESIGNATION OF AREAS HAVING es.

SHORTAGES OF VETERINARY ii) In flat terrain or in areas connected by

PROFESSIONAL(S) erstate highways: 25 miles. Vithin inner portions of metropolitan

Part 1 Geographic Areas as, information on the public transporion system will be used to determine the A. Criteria for Food Animal Veterinary Shorta corresponding to 30 minutes travel age.

A geographic area will be designated as 5. Counting of Pharmacists.

having a shortage of food animal veterinary All active pharmacists within the area will professional(s) if the following three criteria

counted, except those engaged in teach- are met: B, administration, or pharmaceutical re- 1. The area is a rational area for the delivarch.

ery of veterinary services. 3. Determination of Estimated Requirement for 2. The ratio of veterinary livestock units harmacists.

to food animal veterinarians in the area 18 at (a) Basic estimate. The basic estimated re- least 10,000:1, and the computed food animal uirement for pharmacists will be calculated veterinarian shortage to meet this ratio is at 3 follows:

least 0.5. lasic pharmacist requirement = .15 (resi

3. Food animal veterinarians in contiguous dent civilian population/1,000) + .035 x

areas are overutilized or excessively distant (total number of physicians engaged in

from the population of the area under con

sideration. patient care in the area).

B. Criteria for Companion Animal Veterinary (b) Adjusted estimate. For areas with less Shortage. chan 20,000 persons, the following adjustment A geographic area will be designated as is made to the basic estimate to compensate having a shortage of companion animal vetfor the lower expected productivity of small erinary professional(s) if the following three practices.

criteria are met: Estimated pharmacist requirement = (2

1. The area is a rational area for the delivpopulation/20,000) * basic pharmacist re

ery of veterinary services. quirement.

2. The ratio of resident civilian population

to number of companion animal veterinar4. Size of Shortage Computation.

ians in the area is at least 30,000:1 and the The size of the shortage will be computed

computed companion animal veterinary as follows:

shortage to meet this ratio is at least 0.5. Pharmacist shortage = estimated pharmacist 3. Companion animal veterinarians in con

requirement - number of pharmacists tiguous areas are overutilized or excessively available.

distant from the population of the area 5. Contiguous Area Considerations.

under consideration. Pharmacists in areas contiguous to an area C. Methodology. being considered for designation will be con- In determining whether an area meets the sidered excessively distant or overutilized if criteria established by paragraphs A and B of either:

this part, the following methodology will be (a) Pharmacy professional(s) in contiguous used: areas are more than 30 minutes travel time 1. Rational Areas for the Delivery of Veterifrom the center of the area under consider

nary Services. ation, or

(a) The following areas will be considered (b) The number of pharmacists in each con- rational areas for the delivery of veterinary tiguous area is less than or equal to the esti- services: mated requirement for pharmacists for that (1) A county, or a group of contiguous contiguous area (as computed above).

counties whose population centers are within C. Determination of Degree-of-Shortage.

40 minutes travel time of each other. Designated areas will be assigned to de

(ii) A portion of a county (or an area made gree-of-shortage groups, based on the propor- up of portions of more than one county) tion of the estimated equirement for phar- which, because of topography, market and/or macists which is currently available in the

transportation patterns or other factors, has area, as follows:

limited access to contiguous area resources, Group 1-Areas with no pharmacists.

as measured generally by a travel time of Group 2-Areas where the ratio of avail- greater than 40 minutes to these resources. able pharmacists to pharmacists required is (b) The following distances will be used as less than 0.5.

guidelines in determining distances corGroup 3-Areas where the ratio of avail. responding to 40 minutes travel time: able pharmacists to pharmacists required is (1) Under normal conditions with primary between 0.5 and 1.0.

roads available: 25 miles.

po

(11) In mountainous terrain or in areas with only secondary roads available: 20 miles.

(111) In flat terrain or in areas connected by Interstate highways: 30 miles.

2. Determination of Number of Veterinary Livestock Units (VLU) Requiring Care.

Since various types of food animals require varying amounts of veterinary care, each type of animal has been assigned a weight indicating the amount of veterinary care it requires relative to that required by a milk cow. Those weights are used to compute the number of “Veterinary Livestock Units" (VLU) for which veterinary care is required.

The VLU is computed as follows: Veterinary Livestock Units (VLU)=(number

of milk cows) +.2x(number of other cattle and calves) +.05x(number of hogs and pigs) +.05x(number of sheep) +.002x(number of poultry).

3. Counting of Food Animal Veterinarians.

The number of food animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories according to the average fraction of practice time in that category which is devoted to food animal veterinary care, as follows: Number of

Food Animal Veterinarians=(number of veterinarians

in large animal practice, exclusively) +(number of veterinarians in bovine prac

tice, exclusively) +(number of veterinarians in poultry prac

tice, exclusively) +.75x(mixed practice veterinarians with

greater than 50% of practice in large ani

mal care) +.5x(mixed practice veterinarians with ap

proximately 50% of practice in large ani

mal care) +.25x(mixed practice veterinarians with less

than 50% of practice in large animal

care). 4. Counting of Companion Animal Veterinarians (that is, those who provide services for dogs, cats, horses, and any other animals maintained as companions to the owner rather than as food animals).

The number of full-time equivalent companion animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories by the average portion of their practice which is devoted to companion animal care by the practitioners within that category, as follows: Number of Companion Animal

Veterinarians=(number of veterinarians

in large animal practice, exclusively) +(number of veterinarians in equine prac

tice, exclusively)

+.75x(mixed practice veterinarians

greater than 50% of practice in small a

mal care) +.5x(mixed practice veterinarians with

proximately 50% of practice in small a

mal care) +.25x(mixed practice veterinarians with :

than 50% of practice in small anin

care). 5. Size of Shortage Computation.

The size of shortage will be computed I follows:

(a) Food animal veterinars shortage=(VLU/10,000)-(number of food a mal veterinarians).

(b) Companion animal veterinaria shortage=(resident civilian 30,000)-(number of companion animal vetar narians).

6. Contiguous Area Considerations.

Veterinary professional(s) in areas contig uous to an area being considered for desig tion will be considered excessively distas from the population of the area a overutilized if one of the following cond tions prevails in each contiguous area:

(a) Veterinary professional(s) in the sce tiguous area are more than 60 minutes travel time from the center of the area being con sidered for designation (measured in accord ance with paragraph C.1.(b) of this part).

(b) In the case of food animal veterinary professional(s), the VLU-to-food animal vet erinarian ratio in the contiguous area is in excess of 5,000:1.

(c) In the case of companion animal veter: nary professional(s), the population-to-companion animal veterinarian ratio in the con tiguous area is in excess of 15,000:1.

C. Determination of Degree-of-Shortage.

Designated areas will be assigned to de gree-of-shortage groups as follows:

Group 1-Areas with a food animal veterinarian shortage and no veterinarians.

Group 2-Areas (not included above) with a food animal veterinarian shortage and no food animal veterinarians.

Group 3-All other food animal veterinar ian shortage areas.

Group 4All companion animal shortage areas (not included above) having no veterinarians.

Group 5-All other companion animal shortage areas.

PART 6-FEDERAL TORT CLAIMS

ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS

Sec. 6.1 Applicability. 6.2 Definitions. 6.3 Eligible entities. 6.4 Covered individuals.

Deeming process for eligible entities. (3) Section 340 of the Act (relating to Covered acts and omissions.

grants for health services for the homeAUTHORITY: Sections 215 and 224 of the Pub

less); and Health Service Act, 42 U.S.C. 216 and 233. (4) Section 340A of the Act (relating

to grants for health services for resiSOURCE: 60 FR 22532, May 8, 1995, unless

dents of public housing). herwise noted.

(b) Subrecipients. Entities that are 3.1 Applicability.

subrecipients of grant funds described

in paragraph (a) of this section are eliThis part applies to entities and indi

gible for coverage only if they provide duals whose acts and omissions relat- a full range of health care services on i to the performance of medical, sur- behalf of an eligible grantee and only ical, dental, or related functions are

for those services carried out under the overed by the Federal Tort Claims Act

grant funded project. 28 U.S.C. 1346(b) and 2671-2680) in acordance with the provisions of section 86.4 Covered individuals. 24(g) of the Public Health Service Act

(a) Officers and employees of a cov42 U.S.C. 233(g)).

ered entity are eligible for coverage

under this part. 6.2 Definitions.

(b) Contractors of a covered entity Act means the Public Health Service who are physicians or other licensed or Act, as amended.

certified health care practitioners are Attorney General means the Attorney eligible for coverage under this part if General of the United States and any they meet the requirements of section other officer or employee of the De- 224(g)(5) of the Act. partment of Justice to whom the au- (c) An individual physician or other thority involved has been delegated.

licensed or certified health care practiCovered entity means an entity de

tioner who is an officer, employee, or scribed in $6.3 which has been deemed

contractor of a covered entity will not by the Secretary, in accordance with

be covered for acts or omissions occur86.5, to be covered by this part.

ring after receipt by the entity employCovered individual means an individ

ing such individual of notice of a final ual described in $6.4.

determination by the Attorney General Effective date as used in $6.5 and $6.6

that he or she is no longer covered by refers to the date of the Secretary's de

this part, in accordance with section termination that an entity is a covered

224(1) of the Act. entity.

86.5 Deeming process for eligible entiSecretary means the Secretary of ties. Health and Human Services (HHS) and

Eligible entities will be covered by any other officer or employee of the

this part only on and after the effective Department of HHS to whom the au

date of a determination by the Secthority involved has been delegated.

retary that they meet the requireSubrecipient means an entity which

ments of section 224(h) of the Act. In receives a grant or a contract from a

making such determination, the Seccovered entity to provide a full range

retary will receive such assurances and of health services on behalf of the cov

conduct such investigations as he or ered entity.

she deems necessary. $6.3 Eligible entities.

8 6.6 Covered acts and omissions. (a) Grantees. Entities eligible for cov

(a) Only acts and omissions occurring erage under this part are public and on and after the effective date of the nonprofit private entities receiving Secretary's determination under $6.5 Federal funds under any of the follow- and before the later date specified in ing grant programs:

section 224(g)(3) of the Act are covered (1) Section 329 of the Act (relating to by this part. grants for migrant health centers);

(b) Only claims for damage for per(2) Section 330 of the Act (relating to sonal injury, including death, resulting grants for community health centers); from the performance of medical, sur

room. The Secretary would be auth ized to determine that this coverage necessary to facilitate the provision services to the grantee's patients, a that it would therefore be covered i paragraph (d)(2) of this section.

(3) A homeless health services gran ee makes arrangements with loa community providers for after-hou coverage of its patients. The grantes physicians are required by their en ployment contracts to provide periodi cross-coverage for patients of the providers, in order to make this a rangement feasible. The Secretary Di determine that the arrangement i within the scope of paragraph (d)(3) this section. (60 FR 22532, May. 8, 1995; 60 FR 30073, Jei 13, 1995)

PART 7-DISTRIBUTION OF REF ERENCE BIOLOGICAL STAND ARDS AND BIOLOGICAL PREP ARATIONS

gical, dental, or related functions are covered by this part.

(c) With respect to covered individuals, only acts and omissions within the scope of their employment (or contract for services) are covered. If a covered individual is providing services which are not on behalf of the covered entity, such as on a volunteer basis or on behalf of a third-party (except as described in paragraph (d) of this section), whether for pay or otherwise, acts and omissions which are related to such services are not covered.

(d) Only acts and omissions related to the grant-supported activity of entities are covered. Acts and omissions related to services provided to individuals who are not patients of a covered entity will be covered only if the Secretary determines that:

(1) The provision of the services to such individuals benefits patients of the entity and general populations that could be served by the entity through community-wide intervention efforts within the communities served by such entity;

(2) The provision of the services to such individuals facilitates the provision of services to patients of the entity; or

(3) Such services are otherwise required to be provided to such individuals under an employment contract or similar arrangement between the entity and the covered individual.

(e) Examples. The following are examples of situations within the scope of paragraph (d) of this section:

(1) A community health center deemed to be a covered entity establishes a school-based or school-linked health program as part of its grant supported activity. Even though the students treated are not necessarily registered patients of the center, the center and its health care practitioners will be covered for services provided, if the Secretary makes the determination in paragraph (d)(1) of this section.

(2) A migrant health center requires its physicians to obtain staff privileges at a community hospital. As a condition of obtaining such privileges, and thus being able to admit the center's patients to the hospital, the physicians must agree to provide occasional coverage of the hospital's emergency

Sec.
7.1 Applicability.
7.2 Establishment of a user charge.
7.3 Definitions.
7.4 Schedule of charges.
7.5 Payment procedures.
7.6 Exemptions.

AUTHORITY: Sec. 215, 58 Stat. 690, as amend ed (42 U.S.C. 216); title V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701); and sec. 352 of the Public Health Service Act, as amended (42 U.S.C. 263).

SOURCE: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.

87.1 Applicability,

The provisions of this part are applicable to private entities requesting from the Centers for Disease Control (CDC) reference biological standards and biological preparations for use in their laboratories.

87.2 Establishment of a user charge.

Except as otherwise provided in $7.6, a user charge shall be imposed to cover the cost to CDC of producing and distributing reference biological standards and biological preparations. $7.3 Definitions.

Biological standards means a uniform and stable reference biological sub

ince which allows measurements of ative potency to be made and de"ibed in a common currency of intertional and national units of activity. Biological preparations means a refence biological substance which may

used for a purpose similar to that of standard, but which has been estabshed without a full collaborative udy, or where a collaborative study Ls shown that it is not appropriate to tablish the preparation as an interitional standard. 7.4 Schedule of charges. The charges imposed in $7.2 are based n the amount published in CDC's price st of available products. These harges will reflect direct costs (such s salaries and equipment), indirect osts (such as rent, telephone service, und a proportionate share of managenent and administrative costs), and he costs of particular ingredients. Charges may vary over time and between different biological standards or biological preparations, depending

upon the cost of ingredients and the complexity of production. An up-todate schedule of charges is available from the Biological Products Branch, Center for Infectious Diseases, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333. $7.5 Payment procedures.

The requester may obtain information on terms of payment and a fee schedule by writing the “Centers for Disease Control," Financial Management Office, Buckhead Facility, Room 200, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333.

87.6 Exemptions.

State and local health departments, governmental institutions (e.g., State hospitals and universities), the World Health Organization, and ministries of health of foreign governments may be exempted from paying user charges, when using biological standards or biological preparations for public health purposes.

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