26160 Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Proposed Rules 

Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.lD, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA)(42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This proposed 

rule involves establishing a safety zone 

around a fireworks display. The 

fireworks are launched from land and 

the safety zone is intended to keep 

mariners away from any fall out that 

may enter the water. Therefore this rule 

is expected to be categorically excluded, 

under section 2.B.2. Figure 2–1, 

paragraph 34(g), of the Instruction. 

A preliminary environmental analysis 

checklist supporting this determination 

is available in the docket where 

indicated under ADDRESSES. We seek 

any comments or information that may 

lead to the discovery of a significant 

environmental impact from this 

proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6 and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

2. Add § 165.T05–0293 to read as 

follows: 

§ 165.T05–0293 Safety Zone; Reedville 

July 4th Celebration, Cockrell’s Creek, 

Reedville, VA. 

(a) Regulated Area. The following area 

is a safety zone: specified waters of 

Cockrell’s Creek located within a 420 

foot radius of the fireworks display at 

approximate position 37°49′54′′ N/ 

076°16′44′′ W (NAD 1983) in the 

vicinity of Reedville, VA. 

(b) Definition. For the purposes of this 

part, Captain of the Port Representative 

means any U.S. Coast Guard 

commissioned, warrant or petty officer 

who has been authorized by the Captain 

of the Port, Hampton Roads, Virginia to 

act on his behalf. 

(c) Regulations. (1) In accordance with 

the general regulations in 165.23 of this 

part, entry into this zone is prohibited 

unless authorized by the Captain of the 

Port, Hampton Roads or his designated 

representatives. 

(2) The operator of any vessel in the 

immediate vicinity of this safety zone 

shall: 

(i) Stop the vessel immediately upon 

being directed to do so by any 

commissioned, warrant or petty officer 

on shore or on board a vessel that is 

displaying a U.S. Coast Guard ensign. 

(ii) Proceed as directed by any 

commissioned, warrant or petty officer 

on shore or on board a vessel that is 

displaying a U.S. Coast Guard ensign. 

(3) The Captain of the Port, Hampton 

Roads can be reached through the Sector 

Duty Officer at Sector Hampton Roads 

in Portsmouth, Virginia at telephone 

Number (757) 668–5555. 

(4) The Coast Guard Representatives 

enforcing the safety zone can be 

contacted on VHF–FM marine band 

radio channel 13 (165.65Mhz) and 

channel 16 (156.8 Mhz). 

(d) Enforcement Period: This 

regulation will be enforced on July 2, 

2010 from 8 p.m. until 10 p.m. 

Dated: April 24, 2010. 

M.S. Ogle, 

Captain, U.S. Coast Guard, Captain of the 

Port, Hampton Roads. 

[FR Doc. 2010–11087 Filed 5–10–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 1 

RIN 2900–AN42 

Drug and Drug-Related Supply 

Promotion by Pharmaceutical 

Company Sales Representatives at VA 

Facilities 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule; republication. 

SUMMARY: The Department of Veterans 

Affairs (VA) is republishing the 

proposed rule document that was 

published on May 5, 2010, in the 

Federal Register to provide the address 

that the public needs to submit their 

comments. In that document, we 

inadvertently omitted the ADDRESSES

section for public comments. As a 

convenience to the public, instead of 

merely publishing a correction 

document, we are republishing the 

entire proposed rule with the 

ADDRESSES section and a new 60-day 

comment period. These are the only two 

changes made to the proposed rule. 

The purposes of the proposed rule are 

to reduce or eliminate any potential for 

disruption in the patient care 

environment, manage activities and 

promotions at VA facilities, and provide 

sales representatives with a consistent 

standard of permissible business 

practice at VA facilities. It would also 

facilitate mutually beneficial 

relationships between VA and such 

sales representatives. 

DATES: Comments must be received by 

VA on or before July 12, 2010. 

ADDRESSES: Written comments may be 

submitted through http:// 

www.Regulations.gov; by mail or hand 

delivery to the Director, Regulations 

Management (02REG), Department of 

Veterans Affairs, 810 Vermont Ave., 

NW, Room 1068, Washington, DC 

20420; or by fax to (202) 273–9026. 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AN42—Drug and Drug-Related Supply 

Promotion by Pharmaceutical Company 

Sales.’’ Copies of comments received 

will be available for public inspection in 

the Office of Regulation Policy and 

Management, Room 1063B, between the 

hours of 8 a.m. and 4:30 p.m., Monday 

through Friday (except holidays). Please 

call (202) 461–4902 (this is not a tollfree number) for an appointment. In 

addition, during the comment period, 

comments may be viewed online 

through the Federal Docket Management 

System at http://www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Louis E. Cobuzzi, PBM Services (119), 

Veterans Health Administration, 

Department of Veterans Affairs, 810 

Vermont Avenue, NW., Washington, DC 

20420; (202) 461–7362. (This is not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: On May 5, 

2010, VA published this proposed rule 

in the Federal Register at 75 FR 24510, 

with an error. We inadvertently omitted 

the ADDRESSES section for public 

comments. We are republishing the 

proposed rule with the address 

information where the public can 

submit their comments and with a new 

60-day comment period. 

Under 38 U.S.C. 303, the Secretary of 

Veterans Affairs is responsible for ‘‘the 

proper execution and administration of 

all laws administered by the Department 

and for the control, direction, and 

management of the Department.’’ The 

Secretary has authority to prescribe all 

rules necessary to carry out the laws 

administered by the Department, such 

as section 303 regarding control and 

management of the Department. See 38 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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U.S.C. 501(a). VA has implemented this 

authority, as it pertains to management 

of VA facilities, in 38 CFR part 1. 

VA proposes to amend 38 CFR part 1 

to regulate access to VA medical 

facilities by sales representatives 

(including account managers and 

clinical liaisons) promoting drugs and 

drug-related supplies. Currently, many 

policies regarding access to VA facilities 

are established and maintained at the 

local level, either by Veterans Integrated 

Service Network (VISN) leaders or by 

administrators at particular facilities. A 

VISN, which we define in proposed 

§ 1.220(a), is a network of all VA health 

care facilities located in a particular 

region. There are 21 such regions, and 

the areas that they service can be found 

at http://www.vacareers.va.gov/ 

networks.cfm. The proposed rule would 

prescribe Department-wide rules that 

must be followed at the VISN and local 

levels. We note that the proposed rules 

are consistent with past VA policy and 

practice. 

VA proposes this rule to prescribe the 

circumstances under which sales 

representatives from pharmaceutical 

companies promoting drugs and drugrelated supplies may be granted access 

to VA facilities. This rule is necessary 

to limit such access to those 

circumstances that benefit VA from an 

educational standpoint, while avoiding 

potential disturbance to patient care and 

ensuring compliance with standards of 

ethical conduct. Pharmaceutical sales 

representatives have heavy interaction 

with local VA staff each year, and this 

rule will ensure that their activities do 

not negatively affect the quality of 

patient care. The proposed rule would 

also assist these sales representatives by 

providing clear standards, applicable to 

all VA facilities nationwide, which are 

consistent with current practices at most 

VA facilities. The proposed rule would 

require the Chief of Pharmacy or other 

official responsible for such decisions to 

approve educational programs and 

materials presented or furnished by 

these sales representatives, so as to 

ensure that those programs and 

materials focus on clinician education 

as opposed to marketing of drugs and 

drug-related supplies. The proposed 

rule would generally deny sales 

representatives access to patient care 

areas in VA facilities to ensure patient 

privacy, and would require them to 

make appointments at the facilities they 

intend to visit as opposed to open and 

unrestricted access. Further, the 

proposed rule would prohibit sales 

representatives from furnishing any 

food to VA staff or gifts above the de 

minimis value set forth in the standards 

of ethical conduct for Federal 

employees, and would prohibit VA 

employees’ personal acceptance of drug 

samples. 

We propose to designate this rule as 

§ 1.220. Currently, § 1.218, regarding 

security and law enforcement at VA 

facilities, describes general behavior 

that is prohibited on the grounds of VA 

property. Proposed § 1.220, would 

govern the behavior of particular 

individuals (sales representatives) on 

the grounds of VA medical facilities, but 

is not a security and law enforcement 

provision as it is not our intention to 

prescribe a fine for failure to comply 

with this rule. (VA is required to 

provide for a fine and/or imprisonment 

for violations of the security and law 

enforcement provisions at § 1.218 (38 

U.S.C. 901)). 

In proposed paragraph (a), we would 

set forth definitions applicable to this 

section. In particular, we would use 

current policy and practice to define 

‘‘Criteria-for-use’’ as clinical criteria 

describing how certain drugs may be 

used in VA. The criteria-for-use are, and 

will continue to be, posted on VA’s Web 

site at http://www.pbm.va.gov. The 

definition would note that local 

exceptions may apply ‘‘for operational 

reasons.’’ An example of the need for a 

local exception might be if a particular 

facility within a VISN (e.g., a 

Community-Based Outpatient Clinic 

(CBOC)) did not have a physician with 

the required expertise about a particular 

drug to prescribe. Under the exception, 

a primary care provider might direct 

that the drug be prescribed at a different 

facility within the VISN (e.g., a VA 

hospital) where a suitable physician 

could be found. We note that such 

exceptions at the local level are not 

posted on our website, or elsewhere, 

because they are subject to change and 

because they do not have any general 

effect on the approval of the drug for use 

within VA. For example, if the 

particular facility hires a physician with 

the required expertise to administer the 

drug within its approved criteria for use, 

or if a physician within the facility 

obtains such expertise through training. 

We also note that such exceptions have 

no effect on the use of the drug 

elsewhere within the VISN. Thus, these 

exceptions do not have a broad or 

national effect on pharmaceutical 

companies. 

We would broadly define ‘‘drugs’’ and 

‘‘drug-related supplies’’ because we 

intend these terms to be inclusive of all 

items typically promoted by 

pharmaceutical sales representatives. 

Similarly, paragraph (a) would define 

‘‘VA medical facility’’ as ‘‘any property 

under the charge and control of VA used 

to provide medical benefits.’’ These 

broad definitions would ensure that the 

proposed rule applies to the largest 

possible number of sales representatives 

and VA medical facilities, including but 

not limited to hospitals, CBOCs, nursing 

homes, and domiciliaries. 

We would define ‘‘VA National 

Formulary (VANF) drugs and/or drugrelated supplies’’ as ‘‘any drug or drugrelated supply that must be available for 

prescription at all VA medical 

facilities,’’ and would provide the public 

with a means to obtain the most current 

list of such drugs or drug-related 

supplies. Non-VANF drugs or drugrelated supplies would be defined as 

drugs or drug-related supplies that are 

not included on the list of VANF drugs 

or drug-related supplies. 

Proposed paragraph (b) would set 

forth the general rule applicable to the 

promotion of drugs and drug-related 

supplies. It would state that 

notwithstanding § 1.218(a)(8), regarding 

soliciting, vending, and debt collection 

on VA property, VA would allow 

promotion in VA medical facilities of 

VANF and non-VANF drugs or drugrelated supplies if the promotion is 

consistent with criteria-for-use, the drug 

is not classified as non-promotable, and 

the promotion is otherwise consistent 

with the proposed rule and with facility 

initiatives. It would clearly be against 

the interests of VA and our patients to 

allow a promotion that did not meet 

these three criteria, which are consistent 

with past policy and practice. This rule 

would be an exception to § 1.218(a)(8) 

because that rule bars solicitations ‘‘of 

any kind’’ on VA property, and 

otherwise precludes behavior (such as 

posting signs and distributing literature) 

that would be specifically authorized by 

§ 1.220. 

Proposed paragraph (c) would apply 

only to the promotion of non-VANF 

drugs or drug-related supplies without 

criteria-for-use. Such promotions are 

generally for new molecular entities or 

new indications for existing drugs, and 

such promotions must be regulated at 

the local level in order to allow for 

different clinical approaches. The 

promotion of new molecular entities 

would be permitted, but any decision 

allowing the promotion of such a drug 

would be reconsidered if the VANF 

committee reviews the drug and grants 

or denies VANF status. Because new 

molecular entities generally do not have 

a history of significant published 

studies in populations similar to the VA 

patient population and may not be part 

of an established drug class, it is 

important that the proposed rule allow 

VA medical professionals to become 

educated through the promotion of such 

drugs but, at the same time, ensure that 


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26162 Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Proposed Rules 

promotions are consistent with National 

policy. 

Proposed paragraphs (d) and (f) would 

be general rules applicable to 

educational programs and materials 

(paragraph (d)) and the behavior of sales 

representatives on the grounds of VA 

medical facilities (paragraph (f)). These 

rules would attempt to balance the 

benefits of such promotion against the 

need to maintain an appropriate clinical 

environment at VA facilities, 

safeguarding the peace and privacy of 

patients and ensuring that VA personnel 

are able to perform their jobs without 

unnecessary interference. The rules 

would also avoid any appearance of bias 

for or against particular drug 

manufacturers by closely regulating the 

use of advertising material and display 

of brand names, logos, and 

sponsorships. An appearance of bias in 

a drug promotion situation could 

significantly undermine the trust of 

patients or the public in VA doctors. 

Proposed paragraph (e), in addition to 

furthering the policies described above 

that support paragraphs (d) and (f), 

would regulate the receipt of gifts and 

donations to ensure that VA maintains 

appropriate relationships with drug 

companies and suppliers. 

In paragraph (g), we would set forth 

the consequences for noncompliance 

with this section. Any individual, or 

any company, that fails to comply with 

this section would be subject to 

limitations on the right to access VA 

facilities, which may include 

suspension of a sales representative’s 

access privileges, or, in extreme cases, 

denying access to a company’s entire 

sales force. Consistent with the 

Secretary’s delegations of authority to 

the Under Secretary for Health and the 

Under Secretary’s further delegation of 

authority to certain Veterans Health 

Administration officials, the proposed 

rule would authorize the director of the 

VA Medical Center of jurisdiction to 

issue appropriate orders restricting 

access to facilities under the director’s 

control. This is the person who would 

be in the best position to determine 

whether any violation of the proposed 

rule requires restrictions on access to 

particular VA facilities or whether an 

opportunity for corrective action by the 

individual or company will suffice. In 

most cases, we expect that the infraction 

would be adequately addressed by the 

sales representative and no formal 

action would be required. 

Procedurally, paragraph (g) would 

require the director to notify the sales 

representative or company of the 

violation and any proposed restrictions 

on access privileges before issuing any 

final order. The director would be 

required to provide notice to a 

company’s sales manager if the 

proposed action would result in a denial 

of access privileges for the company’s 

entire sales force. Affected persons and 

companies would have 30 days after the 

date of the notice to provide the director 

a response; however, during that 30-day 

period the proposed action would be 

enforced. This is necessary to ensure 

that noncompliance does not continue 

during the 30-day period. After 

considering the requirements of the 

proposed rule, the circumstances of the 

improper conduct, and any response 

submitted by the sales representative or 

company, the director would either 

resolve the matter informally or issue a 

final order restricting access. 

Under proposed paragraph (g)(4), in 

cases where the director issues a final 

order suspending or permanently 

barring a company’s entire sales force, 

the director would be required to 

provide notice of the company’s right to 

a one-time appeal of the matter to the 

Under Secretary for Health. Any such 

request for the Under Secretary’s review 

would be submitted to the director that 

issued the order within 30 days of the 

date of the order. The director would 

then forward the initial notice, the 

company’s response, the director’s 

order, and the company’s request for 

review to the Under Secretary for a final 

decision. The director’s order would be 

enforced until the Under Secretary’s 

review is complete. This mechanism 

provides important due process to 

companies seeking to appeal such final 

orders. 

We note that in most cases, sales 

representatives are considerate of VA’s 

needs and mission, and do not behave 

inappropriately. Accordingly, we do not 

envision that the proposed paragraph (g) 

would be invoked with regularity. 

Executive Order 12866 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Executive Order classifies a regulatory 

action as a ‘‘significant regulatory 

action,’’ requiring review by the Office 

of Management and Budget (OMB) 

unless OMB waives such review, if it is 

a regulatory action that is likely to result 

in a rule that may: (1) Have an annual 

effect on the economy of $100 million 

or more or adversely affect in a material 

way the economy, a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

The economic, interagency, 

budgetary, legal, and policy 

implications of this proposed rule have 

been examined and it has been 

determined to be a significant regulatory 

action under Executive Order 12866. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditure by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

given year. This proposed rule would 

have no such effect on State, local, or 

tribal governments, or on the private 

sector. 

Paperwork Reduction Act 

The proposed rule does not contain 

any collections of information under the 

Paperwork Reduction Act (44 U.S.C. 

3501–3520). 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this proposed rule would not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

proposed rule would not cause a 

significant economic impact on health 

care providers, suppliers, or other small 

entities. The proposed rule generally 

concerns the promotion of drugs by 

large pharmaceutical companies and 

only a small portion of the business of 

such entities concerns VA beneficiaries. 

Therefore, pursuant to 5 U.S.C. 605(b), 

this proposed amendment is exempt 

from the initial and final regulatory 

flexibility analysis requirements of 

sections 603 and 604. 

Catalog of Federal Domestic Assistance 

Numbers 

The Catalog of Federal Domestic 

Assistance numbers and titles are 

64.009 Veterans Medical Care Benefits, 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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64.010 Veterans Nursing Home Care and 

64.011 Veterans Dental Care. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 

of Veterans Affairs, approved this 

document on December 30, 2009, for 

publication. 

List of Subjects in 38 CFR Part 1 

Administrative practice and 

procedure, Archives and records, 

Cemeteries, Claims, Courts, Crime, 

Flags, Freedom of Information, 

Government employees, Government 

property, Infants and children, 

Inventions and patents, Parking, 

Penalties, Privacy, Reporting and 

recordkeeping requirements, Seals and 

insignia, Security measures, Wages. 

Dated: May 7, 2010. 

Robert C. McFetridge, 

Director, Regulation Policy and Management, 

Office of the General Counsel. 

For the reasons set forth in the 

preamble, the Department of Veterans 

Affairs proposes to amend 38 CFR part 

1 as follows: 

PART 1—GENERAL PROVISIONS 

1. The authority citation for part 1 

continues to read as follows: 

Authority: 38 U.S.C. 501(a), and as noted 

in specific sections. 

2. Add § 1.220 to read as follows: 

§ 1.220 Promotion of drugs and drugrelated supplies at VA medical facilities. 

(a) Definitions. For the purposes of 

this section: 

Criteria-for-use means clinical criteria 

developed by the Department of 

Veterans Affairs (VA) at a National level 

that describe how certain drugs may be 

used. VA’s criteria-for-use are available 

to the public at http://www.pbm.va.gov. 

Exceptions may be applied at the local 

level for operational reasons. 

Drugs means pharmaceuticals or 

chemicals intended for use by a patient 

or, in some cases, for medical research. 

Drug-related supplies means supplies 

related to the use of a drug, such as test 

strips or testing devices. 

New molecular entity refers to an 

active ingredient that has never before 

been marketed in the United States in 

any form. 

Non-VANF drugs or drug-related 

supplies are drugs or drug-related 

supplies that do not appear on the VA 

National Formulary. 

VA medical facility means any 

property under the charge and control of 

VA used to provide medical benefits, 

including Community-Based Outpatient 

Clinics and similar facilities. 

VA National Formulary (VANF) drugs 

and/or drug-related supplies means any 

drug or drug-related supply that must be 

available for prescription at all VA 

medical facilities. A list of VANF drugs 

or drug-related supplies is available at 

www.pbm.va.gov, or may be requested 

by contacting the local office of the 

Chief of Pharmacy Services. 

Veterans Integrated Service Network 

(VISN) means one of the 21 networks of 

VA medical facilities. 

(b) Permissible promotion of drugs 

and drug-related supplies. 

Notwithstanding § 1.218(a)(8), VA will 

allow promotion in VA medical 

facilities of VANF and non-VANF drugs 

or drug-related supplies if all of the 

following are true: 

(1) The promotion is consistent with 

any existing criteria-for-use. 

(2) The drug or drug-related supply 

has not been classified by VA as nonpromotable. A list of the drugs or drugrelated supplies classified by VA as 

non-promotable is available at 

www.pbm.va.gov, or may be requested 

by contacting the local office of the 

Chief of Pharmacy Services. 

(3) The promotion is otherwise 

consistent with this section. 

(4) The promotion is consistent with 

facility initiatives. 

(c) Promotion of non-VANF drugs and 

drug-related supplies without criteriafor-use. Under paragraph (b) of this 

section, non-VANF drugs or drugrelated supplies must be promoted 

consistent with any existing criteria-foruse. Non-VANF drugs without criteriafor-use may be promoted only if: 

(1) Specifically permitted by the VISN 

Pharmacy Executive; 

(2) Authorized by the Chief of 

Pharmacy with jurisdiction over the VA 

medical facility at which the promotion 

occurs; and 

(3) In a case where a VISN Formulary 

Leader has permitted the promotion of 

a new molecular entity prior to any 

decision regarding its VANF status, 

such permission must be reconsidered if 

the new molecular entity: 

(i) Is subsequently granted VANF 

status but is labeled non-promotable; or 

(ii) A decision is made to deny VANF 

status. 

(d) Educational programs and 

materials. All educational programs and 

materials must be approved by the 

person at the VA medical facility to 

whom such approval responsibility has 

been delegated under local policy, 

usually the Chief of Pharmacy Services. 

A summary of the program and all 

materials must be provided well in 

advance of the proposed date so that a 

determination of the program’s 

suitability can be made. Programs and 

materials must conform to the following 

guidelines: 

(1) Industry sponsorship must be 

disclosed in the introductory remarks 

and in the announcement brochure. 

Sponsorship includes any contribution, 

whether in the form of staple goods, 

personnel, or financing, intended to 

support the program. 

(2) Marketing activities cannot be 

conducted during an educational 

program. 

(3) Promotional materials are not to be 

placed in any patient care area. 

(4) Programs or materials must not 

offer patients an opportunity to 

participate in manufacturer sponsored 

programs and/or require the furnishing 

of Protected Health Information. 

(5) Patient education materials must 

not contain the name or logo of the 

pharmaceutical manufacturer or be used 

for promotion of specific medications; 

unless the VA Pharmacy Benefits 

Management Service determines that 

the logo or name is inconspicuous and 

legal requirements (e.g., trademark 

requirements) make their removal 

impractical. Even if such materials are 

approved by the VA National Formulary 

committee, the materials must otherwise 

be approved by the local facility in 

accordance with paragraph (d) of this 

section. 

(6) Programs or materials regarding a 

new drug, drug-related supply, or a new 

therapeutic indication for a drug, which 

is already on the VANF but has not yet 

been reviewed by VA, must be clearly 

identified as such. 

(7) Programs or materials focusing 

primarily on non-VANF drugs or drugrelated supplies are discouraged; such 

programs or materials, as well as 

programs or materials regarding VANF 

drugs or drug-related supplies with 

restrictions, must be clearly identified 

as such. 

(e) Providing gifts, drugs or other 

promotional items to VA employees or 

facilities. 

(1) General. No sales representative 

may give, and no VA employee may 

receive, any item (including but not 

limited to promotional materials, 

continuing education materials, 

textbooks, entertainment, and gratuities) 

that exceeds the value permissible for 

acceptance under government ethical 

rules (5 CFR 2635.204(a)). However, 

such items may be donated to a medical 

center library or individual department 


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for use by all employees, in accordance 

with local policies. Gifts of travel in 

support of VA staff official travel may be 

accepted by the Department subject to 

advance legal review in accordance with 

31 U.S.C. 1353, 41 CFR part 304, and 

VA policy regarding such gifts. 

(2) Donations of drugs and drugrelated supplies. Drug samples and free 

drug-related supplies must be approved 

by the person at the medical facility to 

whom such responsibility is delegated 

under local policy, usually the Director. 

Information pertaining to the trial use of 

these drugs or drug-related supplies 

must be forwarded to the VISN 

Pharmacy Executive or VISN Formulary 

Committee. Drugs or drug-related 

supplies donated for the intended 

purpose of patient use must be 

delivered to the Office of the Chief of 

Pharmacy Services for proper storage, 

documentation and dispensing. These 

donated items must not be labeled 

‘‘sample,’’ ‘‘professional sample,’’ or 

similar words, unless VA grants an 

exception in the interests of patient 

care. Drug or supply samples may not be 

provided to VA staff for their personal 

use. 

(3) Donations of food. Sales 

representatives may not provide food 

items of any type or any value to VA 

staff (including volunteers and without 

compensation employees) or bring food 

items into VA medical facilities for use 

by non-VA staff (e.g., employees of 

affiliates). This constraint applies to all 

sales representatives who have business 

relationships with VA Clinical Services. 

(f) Conduct of sales representatives. In 

addition to any other rules in this 

section, sales representatives (i.e., 

promoters) of drugs and drug-related 

supplies must conform to the following: 

(1) Sales representatives must provide 

accurate information. Sales 

representatives must ensure that all 

drugs or drug-related supplies are 

discussed, displayed and represented 

accurately, in accordance with any 

applicable Food and Drug 

Administration and VANF guidelines 

and restrictions. 

(2) Contacts are to be by appointment 

only. In order to minimize the potential 

for disruption of patient care activities, 

a sales representative must schedule an 

appointment before each specific visit. 

Access to VA medical facilities by a 

sales representative without an 

appointment is not permitted under any 

circumstances. VA medical facilities 

may develop a list of individuals or 

departments that do not wish to be 

called-on by sales representatives. A 

sales representative must not attempt to 

make appointments with individuals or 

departments on the list. The list may be 

obtained at the local office of the Chief 

of Pharmacy Services. 

(3) Contacts with VA staff without an 

appointment. A sales representative 

visiting a VA medical facility for a 

scheduled appointment may not initiate 

requests for meetings with other VA 

staff; however, sales representatives may 

respond to requests initiated by VA staff 

during the visit. 

(4) Paging VA employees. The sales 

representative may not use the public 

address (paging) system to locate any 

VA employee. Contacts using the 

electronic paging system (beepers) are 

permissible only if specifically 

requested by the VA employee. 

(5) Marketing to students. Sales 

representatives are prohibited from 

marketing to medical, pharmacy, 

nursing and other health profession 

students (including residents). 

Exceptions may be permitted when 

approved by, and conducted in the 

presence of, their clinical staff member. 

(6) Attendance at conferences. A sales 

representative is not allowed to attend 

a medical center conference where 

patient-specific material is discussed or 

presented. 

(7) Patient care areas. Sales 

representatives generally may not wait 

for scheduled appointments or make 

presentations in patient-care areas, but 

may briefly travel through them, when 

necessary, to meet in a staff member’s 

office. Patient-care areas include, but are 

not limited to: 

(i) Patient rooms and ward areas 

where patients may be encountered; 

(ii) Clinic examination rooms; 

(iii) Nurses stations; 

(iv) Intensive care units; 

(v) Operating room suites; 

(vi) Emergency rooms; 

(vii) Urgent care centers; and 

(viii) Ambulatory treatment centers. 

(g) Failure to properly promote drugs 

or drug-related supplies within VA. 

(1) A sales representative’s 

commercial visiting privileges at one or 

more VA medical facilities may be 

restricted by the written order of the 

director of the VA medical center of 

jurisdiction if the director determines 

the sales representative failed to comply 

with the requirements of this section. 

The director will notify the 

representative of the noncompliance 

and of the director’s proposed action 

under paragraph (g)(3) of this section. 

The director will also notify the 

manager or other appropriate supervisor 

of the sales force if there have been 

instances of widespread misconduct by 

an individual, or by multiple 

representatives of the same sales force, 

and the director proposes to suspend or 

permanently revoke the sales force’s 

commercial visiting privileges at one or 

more VA medical facilities. The notice 

will offer 30 days to provide a response; 

however, the proposed action will be 

enforced effective the date of the notice. 

(2) At the end of the 30-day period for 

a response, or after the director receives 

a timely response, the director may, as 

appropriate to prevent future 

noncompliance, issue a written order 

suspending or permanently revoking the 

sales representative’s or sales force’s 

commercial visiting privileges, impose a 

lesser sanction, or decide that no further 

action is required. In determining the 

appropriate action, the director shall 

consider the requirements of this 

section, the circumstances of the 

improper conduct, any prior acts of 

misconduct by the same sales 

representative or sales force, any 

response submitted by the sales 

representative or sales force manager, 

and any prior orders issued or other 

actions taken with respect to similar 

acts of misconduct. Any final order 

issued by the director shall include a 

summary of the circumstances of the 

violation, a listing of the specific 

provisions of this section that the sales 

representative or sales force violated, 

and the bases for the director’s 

determination regarding the appropriate 

remedial action. 

(3) Actions that may be imposed 

under this section include limitation, 

suspension, or permanent revocation of 

commercial visiting privileges at one or 

more VA medical facilities. Instances of 

widespread misconduct by an 

individual or multiple sales 

representatives may result in the 

imposition of a VISN-wide or VA-wide 

limitation, suspension, or revocation of 

commercial visiting privileges of the 

entire sales force of a given 

manufacturer, if necessary to prevent 

further noncompliance. The director 

will provide the sales representative or 

sales force manager written notice of 

any final order issued under this 

section. 

(4) Notice concerning a final order 

suspending or permanently revoking an 

entire sales force’s commercial visiting 

privileges shall include specific notice 

concerning the right to appeal the 

director’s order to the Under Secretary 

for Health. The sales force manager or 

other corporate representative may 

request the Under Secretary’s review 

within 30 days of the date of the 

director’s order by submitting a written 

request to the director. The director 

shall forward the initial notice, any 

response, the final order, and the 

request for review to the Under 

Secretary for a final VA decision. VA 

will enforce the director’s order while it 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Proposed Rules 26165 

is under review by the Under Secretary. 

The director will provide the individual 

who made the request written notice of 

the Under Secretary’s decision. 

(Authority: 38 U.S.C. 501) 

[FR Doc. 2010–11170 Filed 5–10–10; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 80 

[EPA–HQ–OAR–2007–1158; FRL–9147–5] 

RIN 2060–AO71 

Regulation of Fuels and Fuel 

Additives: Alternative Affirmative 

Defense Requirements for Ultra-Low 

Sulfur Diesel and Gasoline Benzene 

Technical Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed Rule. 

SUMMARY: EPA is issuing a proposed 

rule to amend the diesel sulfur 

regulations to allow refiners, importers, 

distributors, and retailers of highway 

diesel fuel the option to use an 

alternative affirmative defense if the 

Agency finds highway diesel fuel 

samples above the specified sulfur 

standard at retail facilities. This rule 

also proposes to amend the gasoline 

benzene regulations to allow 

disqualified small refiners the same 

opportunity to generate gasoline 

benzene credits as that afforded to nonsmall refiners. 

DATES: Comments: Comments must be 

received on or before June 10, 2010. 

Under the Paperwork Reduction Act, 

comments on the information collection 

provisions must be received by OMB on 

or before June 10, 2010. 

Hearings: If EPA receives a request 

from a person wishing to speak at a 

public hearing by May 26, 2010 , a 

public hearing will be held at a time and 

location to be announced in a 

subsequent Federal Register notice. To 

request to speak at a public hearing, 

send a request to the contact in FOR

FURTHER INFORMATION CONTACT. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2007–1158, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: a-and-r-docket@epa.gov. 

• Fax: (202) 566–9744 

• Mail: Air and Radiation Docket, 

Environmental Protection Agency, 

Mailcode: 2822T, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

• Hand Delivery: EPA Docket Center, 

Room 3334, EPA West Building, 1301 

Constitution Avenue, NW., Washington, 

DC, Attention Air Docket ID No. EPA– 

HQ–OAR–2007–1158. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Comments should be submitted 

according to the detailed instructions in 

the ADDRESSES section of the 

corresponding Direct Final Rule located 

in the ‘‘Rules’’ section of this Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Jaimee Dong, Compliance and 

Innovative Strategies Division, Office of 

Transportation and Air Quality, Office 

of Air and Radiation, Environmental 

Protection Agency, Mail Code 6405J, 

1200 Pennsylvania Avenue, 

Washington, DC 20460; telephone 

number: (202) 343–9672; fax number: 

(202) 343–2800; e-mail address: 

Dong.Jaimee@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why is EPA issuing this proposed 

rule? 

EPA is issuing a proposed rule to 

amend the diesel sulfur regulations to 

allow refiners, importers, distributors, 

and retailers of highway diesel fuel the 

option to use an alternative affirmative 

defense if the Agency finds highway 

diesel fuel samples above the specified 

sulfur standard at retail facilities. This 

rule also proposes to amend the gasoline 

benzene regulations to allow 

disqualified small refiners the same 

opportunity to generate gasoline 

benzene credits as that afforded to nonsmall refiners. 

We have also published a direct final 

rule to make these same amendments in 

the ‘‘Rules and Regulations’’ section of 

this Federal Register because we view 

this as a non-controversial action and 

anticipate no adverse comment. We 

have explained our reasons for this 

action in the preamble to the direct final 

rule. 

If we receive no adverse comment, we 

will not take further action on this 

proposed rule. If EPA receives adverse 

comment on a distinct provision of this 

rulemaking, we will publish a timely 

withdrawal in the Federal Register 

indicating which provisions of the 

direct final rule we are withdrawing. 

The provisions that are not withdrawn 

will go into effect on the effective date 

noted in the DATES section of the direct 

final rule, notwithstanding adverse 

comment on any other provision. We 

would address all public comments in 

any subsequent final rule based on this 

proposed rule. 

We do not intend to institute a second 

comment period on the action. Any 

parties interested in commenting must 

do so at this time. 

The regulatory text for the proposal is 

identical to that for the direct final rule 

and is published in the ‘‘Rules and 

Regulations’’ section of this Federal 

Register. 

II. Does this action apply to me? 

Entities potentially affected by this 

action include those involved with the 

production, importation, distribution, 

marketing, or retailing of diesel fuel and 

production of gasoline. Categories and 

entities affected by this action include: 

Category NAICS Codes a SIC Codes b Examples of potentially regulated entities 

Industry ................................................................................ 324110 2911 Petroleum Refiners. 

Industry ................................................................................ 422710 5171 Diesel Fuel Marketers and Distributors. 

Industry ................................................................................ 484220 4212 Diesel Fuel Carriers. 

a North American Industry Classification System (NAICS). 

bStandard Industrial Classification (SIC) system code. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action; however, other 

types of entities not listed in the table 

could also be affected. To determine 

whether your entity is affected by this 

action, you should examine the 

applicability criteria of Parts 79 and 80 

of title 40 of the Code of Federal 

Regulations. If you have any questions 

regarding applicability of this action to 

a particular entity, consult the person in 

the preceding FOR FURTHER INFORMATION

CONTACT section. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1