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ii) In mountainous terrain or in areas ch only secondary roads available: 15 les. iii) In flat terrain or in areas connected by cerstate highways: 25 miles. Within inner portions of metropolitan eas, information on the public transportion system will be used to determine the -ea corresponding to 30 minutes travel me. 2. Counting of Pharmacists. All active pharmacists within the area will e counted, except those engaged in teachig, administration, or pharmaceutical reearch.

3. Determination of Estimated Requirement for harmacists.

(a) Basic estimate. The basic estimated requirement for pharmacists will be calculated Ls follows: Basic pharmacist requirement = .15 (resi

dent civilian population/1,000) + .035 x (total number of physicians engaged in

patient care in the area). (b) Adjusted estimate. For areas with less than 20,000 persons, the following adjustment is made to the basic estimate to compensate for the lower expected productivity of small practices. · Estimated pharmacist requirement = (2

population/20,000) basic pharmacist re

quirement.
4. Size of Shortage Computation.

The size of the shortage will be computed as follows: Pharmacist shortage = estimated pharmacist

requirement number of pharmacists 1 available.

5. Contiguous Area Considerations. Pharmacists in areas contiguous to an area being considered for designation will be considered excessively distant or overutilized if

Part Geographic Areas A. Criteria for Food Animal Veterinary Shortage.

A geographic area will be designated as having a shortage of food animal veterinary professional(8) if the following three criteria are met:

1. The area is a rational area for the delivery of veterinary services.

2. The ratio of veterinary livestock units to food animal veterinarians in the area is at least 10,000:1, and the computed food animal veterinarian shortage to meet this ratio is at least 0.5.

3. Food animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.

B. Criteria for Companion Animal Veterinary Shortage.

A geographic area will be designated as having a shortage of companion animal veterinary professional(8) if the following three criteria are met:

1. The area is a rational area for the deliv. ery of veterinary services.

2. The ratio of resident civilian population to number of companion animal veterinarians in the area is at least 30,000:1 and the computed companion animal veterinary shortage to meet this ratio is at least 0.5.

3. Companion animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.

C. Methodology.

In determining whether an area meets the criteria established by paragraphs A and B of this part, the following methodology will be used:

1. Rational Areas for the Delivery of Veterinary Services.

(a) The following areas will be considered rational areas for the delivery of veterinary services:

(1) A county, or a group of contiguous counties whose population centers are within 40 minutes travel time of each other.

(ii) A portion of a county (or an area made up of portions of more than one county) which, because of topography, market and/or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to these resources.

(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:

(1) Under normal conditions with primary roads available: 25 miles.

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1 either:

(a) Pharmacy professional(s) in contiguous areas are more than 30 minutes travel time

from the center of the area under considermation, or

(b) The number of pharmacists in each contiguous area is less than or equal to the estimated requirement for pharmacists for that contiguous area (as computed above).

C. Determination of Degree-of-Shortage.

Designated areas will be assigned to degree-of-shortage groups, based on the proportion of the estimated requirement for pharmacists which is currently available in the area, as follows:

Group 1-Areas with no pharmacists. Group 2-Areas where the ratio of available pharmacists to pharmacists required is less than 0.5.

Group 3–Areas where the ratio of available pharmacists to pharmacists required is between 0.5 and 1.0.

(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

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

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

proximately 50% of practice in small

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

than 50% of practice in small an

care). 5. Size of Shortage Computation.

The size of shortage will be computed .. follows:

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

veterinare shortage=(resident civilian

po 30,000) – (number of companion animal veter: narians).

6. Contiguous Area Considerations.

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

(a) Veterinary professional(s) in the cos tiguous area are more than 60 minutes trare time from the center of the area being cossidered 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 Fe; erinarian ratio in the contiguous area is it excess of 5,000:1.

(c) In the case of companion animal veterinary professional(s), the population-to-com panion 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 do food animal veterinarians.

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

Group 4-All 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

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

Deeming process for eligible entities.

Covered acts and omissions. AUTHORITY: Sections 215 and 224 of the Pub

Health Service Act, 42 U.S.C. 216 and 233. SOURCE: 60 FR 22532, May 8, 1995, unless Cherwise noted. 6.1 Applicability.

This part applies to entities and indiiduals whose acts and omissions relatd to the performance of medical, surical, dental, or related functions are overed by the Federal Tort Claims Act 28 U.S.C. 1346(b) and 2671–2680) in acordance with the provisions of section 24(g) of the Public Health Service Act 42 U.S.C. 233(g)).

(3) Section 340 of the Act (relating to grants for health services for the homeless); and

(4) Section 340A of the Act (relating to grants for health services for residents of public housing).

(b) Subrecipients. Entities that are subrecipients of grant funds described in paragraph (a) of this section are eligible for coverage only if they provide a full range of health care services on behalf of an eligible grantee and only for those services carried out under the grant funded project. 86.4 Covered individuals.

(a) Officers and employees of a covered entity are eligible for coverage under this part.

(b) Contractors of a covered entity who are physicians or other licensed or certified health care practitioners are eligible for coverage under this part if they meet the requirements of section 224(g)(5) of the Act.

(c) An individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of a covered entity will not be covered for acts or omissions occurring after receipt by the entity employing such individual of notice of a final determination by the Attorney General that he or she is no longer covered by this part, in accordance with section 224(i) of the Act.

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36.2 Definitions.

Act means the Public Health Service Act, as amended.

Attorney General means the Attorney General of the United States and any other officer or employee of the Department of Justice to whom the authority involved has been delegated.

Covered entity means an entity described in $6.3 which has been deemed by the Secretary, in accordance with $6.5, to be covered by this part.

Covered individual means an individsual described in 86.4.

Effective date as used in $6.5 and $6.6 refers to the date of the Secretary's de

termination that an entity is a covered * entity.

Secretary means the Secretary of Health and Human Services (HHS) and any other officer or employee of the

Department of HHS to whom the au*thority involved has been delegated.

Subrecipient means an entity which receives a grant or a contract from a covered entity to provide a full range of health services on behalf of the covered entity.

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86.5 Deeming process for eligible enti

ties. Eligible entities will be covered by this part only on and after the effective date of a determination by the Secretary that they meet the requirements of section 224(h) of the Act. In making such determination, the Secretary will receive such assurances and conduct such investigations as he or she deems necessary. $ 6.6 Covered acts and omissions.

(a) Only acts and omissions occurring on and after the effective date of the Secretary's determination under $6.5 and before the later date specified in section 224(g)(3) of the Act are covered by this part.

(b) Only claims for damage for personal injury, including death, resulting from the performance of medical, sur

$6.3 Eligible entities.

(a) Grantees. Entities eligible for coverage under this part are public and nonprofit private entities receiving Federal funds under any of the following grant programs:

(1) Section 329 of the Act (relating to grants for migrant health centers);

(2) Section 330 of the Act (relating to grants for community health centers);

room. The Secretary would be aut.ized to determine that this coverage necessary to facilitate the provisio services to the grantee's patients, & that it would therefore be covered : paragraph (d)(2) of this section.

(3) A homeless health services graee makes arrangements with loa community providers for after-bocoverage of its patients. The grante physicians are required by their e ployment contracts to provide perioc" cross-coverage for patients of the providers, in order to make this a rangement feasible. The Secretary a determine that the arrangement i within the scope of paragraph (d)(3) this section. (60 FR 22532, May. 8, 1995; 60 FR 38073, Je 13, 1995)

PART 7-DISTRIBUTION OF REF

ERENCE BIOLOGICAL STAND ARDS AND BIOLOGICAL PREPARATIONS

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 amended (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 Serv. ice 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 lative potency to be made and deribed in a common currency of intertional and national units of activity. Biological preparations means a refence biological substance which may i used for a purpose similar to that of standard, but which has been estabshed without a full collaborative rudy, or where a collaborative study is shown that it is not appropriate to stablish the preparation as an interational standard. 7.4 Schedule of charges.

The charges imposed in $7.2 are based n the amount published in CDC's price ist available products. These harges will reflect direct costs (such Ls salaries and equipment), indirect Posts (such as rent, telephone service, und a proportionate share of management and administrative costs), and the 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. 87.5 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.

of

$ 7.6 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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