404 Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Rules and Regulations 

immediately follow the subheading: 

‘‘[Bullet] side effects occur. You may 

report side effects to FDA at 1–800–

FDA–1088.’’ The telephone number 

must appear in a minimum 6–point bold 

letter height or type size. 

* * * * * 

PART 208—MEDICATION GUIDES FOR 

PRESCRIPTION DRUG PRODUCTS 

■ 3. The authority citation for 21 CFR 

part 208 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 357, 360, 371, 374; 42 U.S.C. 

262. 

■ 4. Amend § 208.20 by adding 

paragraph (b)(7)(iii) to read as follows: 

§ 208.20 Content and format of a 

Medication Guide. 

* * * * * 

(b) * * * 

(7) * * * 

(iii) For drug products approved 

under section 505 of the act, the 

following verbatim statement: ‘‘Call 

your doctor for medical advice about 

side effects. You may report side effects 

to FDA at 1–800–FDA–1088.’’

* * * * * 

■ 5. Add part 209 to read as follows: 

PART 209—REQUIREMENT FOR 

AUTHORIZED DISPENSERS AND 

PHARMACIES TO DISTRIBUTE A SIDE 

EFFECTS STATEMENT 

Subpart A—General Provisions 

Sec. 

209.1 Scope and purpose. 

209.2 Definitions. 

Subpart B—Requirements 

209.10 Content and format of the side 

effects statement. 

209.11 Dispensing and distributing the side 

effects statement. 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 371; 42 U.S.C. 241. 

Subpart A—General Provisions 

§ 209.1 Scope and purpose. 

(a) This part sets forth requirements 

for human prescription drug products 

approved under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

and dispensed by authorized dispensers 

and pharmacies to consumers. This part 

requires distribution of a side effects 

statement and applies to new and refill 

prescriptions. This part is not intended 

to apply to authorized dispensers 

dispensing or administering 

prescription drug products to inpatients 

in a hospital or health care facility 

under an order of a licensed 

practitioner, or as part of supervised 

home health care. 

(b) The purpose of providing the side 

effects statement is to enable consumers 

to report side effects of prescription 

drug products to FDA. 

§ 209.2 Definitions. 

For the purposes of this part, the 

following definitions apply: 

Act means the Federal Food, Drug, 

and Cosmetic Act (sections 201–907 (21 

U.S.C. 301–397)). 

Authorized dispenser means an 

individual licensed, registered, or 

otherwise permitted by the jurisdiction 

in which the individual practices to 

provide drug products on prescription 

in the course of professional practice. 

Consumer medication information 

means written information voluntarily 

provided to consumers by dispensing 

pharmacists as part of patient 

medication counseling activities. 

Medication Guide means FDAapproved patient labeling conforming to 

the specifications set forth in part 208 

of this chapter and other applicable 

regulations. 

Pharmacy includes, but is not limited 

to, a retail, mail order, Internet, hospital, 

university, or clinic pharmacy, or a 

public health agency, regularly and 

lawfully engaged in dispensing 

prescription drugs. 

Side effects statement means the 

following verbatim statement: ‘‘Call 

your doctor for medical advice about 

side effects. You may report side effects 

to FDA at 1–800–FDA–1088.’’

Subpart B—Requirements 

§ 209.10 Content and format of the side 

effects statement. 

(a) Content. The side effects statement 

provided with each prescription drug 

product approved under section 505 of 

the act must read: ‘‘Call your doctor for 

medical advice about side effects. You 

may report side effects to FDA at 1–800–

FDA–1088.’’

(b) Format. The side effects statement 

must be in a single, clear, easy-to-read 

type style. The letter height or type size 

used for the side effects statement in 

accordance with paragraphs (b)(1) and 

(b)(2) of § 209.11 must be no smaller 

than 6 points (1 point = 0.0138 inch). 

The letter height or type size for the side 

effects statement under paragraphs 

(b)(3), (b)(4), and (b)(5) of § 209.11 must 

be no smaller than 10 points. 

§ 209.11 Dispensing and distributing the 

side effects statement. 

(a) Each authorized dispenser or 

pharmacy must distribute the side 

effects statement with each prescription 

drug product approved under section 

505 of the act and dispensed. The side 

effects statement must be distributed 

with new and refill prescriptions. 

(b) An authorized dispenser or 

pharmacy must choose one or more of 

the following options to distribute the 

side effects statement: 

(1) Distribute the side effects 

statement on a sticker attached to the 

unit package, vial, or container of the 

drug product; 

(2) Distribute the side effects 

statement on a preprinted pharmacy 

prescription vial cap; 

(3) Distribute the side effects 

statement on a separate sheet of paper; 

(4) Distribute the side effects 

statement in consumer medication 

information; or 

(5) Distribute the appropriate FDAapproved Medication Guide that 

contains the side effects statement. 

Dated: December 21, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–25426 Filed 1–2–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–1385–F2] 

RIN 0938–AO65 

Medicare Program; Revisions to 

Payment Policies Under the Physician 

Fee Schedule, and Other Part B 

Payment Policies for CY 2008; Delay of 

the Date of Applicability of the Revised 

Anti-Markup Provisions for Certain 

Services Furnished in Certain 

Locations (§ 414.50) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule delays until 

January 1, 2009 the applicability of the 

anti-markup provisions in § 414.50, as 

revised at 72 FR 66222, except with 

respect to the technical component of a 

purchased diagnostic test and with 

respect to any anatomic pathology 

diagnostic testing services furnished in 

space that: Is utilized by a physician 

group practice as a ‘‘centralized 

building’’ (as defined at § 411.351 of this 

chapter) for purposes of complying with 

the physician self-referral rules; and 

does not qualify as a ‘‘same building’’

under § 411.355(b)(2)(i) of this chapter. 

DATES: The provisions of this final rule 

are effective January 1, 2008. However, 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Rules and Regulations 405 

the date of applicability of the 

provisions of § 414.50, as revised at 72 

FR 66222, with respect to certain 

services furnished in certain locations, 

as described herein, are delayed until 

January 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Donald Romano, (410) 786–1401. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The final rule with comment period, 

entitled ‘‘Medicare Program; Revisions 

to Payment Policies Under the 

Physician Fee Schedule, and Other Part 

B Payment Policies for CY 2008; 

Revisions to the Payment Policies of 

Ambulance Services Under the 

Ambulance Fee Schedule for CY 2008; 

and the Amendment of the EPrescribing Exemption for Computer 

Generated Facsimile Transmissions,’’

that appeared in the November 27, 2007 

Federal Register (72 FR 66222), 

amended the anti-markup provisions for 

certain diagnostic tests in § 414.50. 

II. Provisions of the Final Regulations 

As amended, the anti-markup 

provisions in § 414.50 will apply to the 

technical and professional components 

of diagnostic tests covered under section 

1861(s)(3) of the Social Security Act (the 

Act) and paid for under part 414 (other 

than clinical diagnostic laboratory tests 

paid under section 1833(a)(2)(D) of the 

Act, which are subject to the special 

billing rules set forth in section 

1833(h)(5)(A) of the Act). If a physician 

or other supplier bills for the technical 

component or professional component 

of a diagnostic test that was ordered by 

the physician or other supplier (or 

ordered by a party related to such 

physician or other supplier through 

common ownership or control) and the 

diagnostic test is either purchased from 

an outside supplier or performed at a 

site other than the office of the billing 

physician or other supplier, the 

payment to the billing physician or 

other supplier (less the applicable 

deductibles and coinsurance paid by the 

beneficiary or on behalf of the 

beneficiary) for the technical component 

or professional component of the 

diagnostic test may not exceed the 

lowest of the following amounts: 

• The performing supplier’s net 

charge to the billing physician or other 

supplier. 

• The billing physician or other 

supplier’s actual charge. 

• The fee schedule amount for the 

test that would be allowed if the 

performing supplier billed directly. 

In revised § 414.50(a)(2)(iii), we 

define the ‘‘office of the billing 

physician or other supplier’’ as medical 

office space where the physician or 

other supplier regularly furnishes 

patient care. With respect to a billing 

physician or other supplier that is a 

physician organization (as defined at 

§ 411.351 of this chapter), the ‘‘office of 

the billing physician or other supplier’’

is space in which the physician 

organization provides substantially the 

full range of patient care services that 

the physician organization provides 

generally. 

Subsequent to the publication of the 

final rule with comment period, we 

received informal comments from 

various stakeholders who allege that the 

application of the rule is unclear with 

respect to whether certain types of space 

arrangements meet the definition of the 

‘‘office of the billing physician or other 

supplier.’’ Further, some of these 

stakeholders assert that patient access 

may be significantly disrupted due to 

the alleged inability of physician groups 

to render services in a cost-effective 

manner if medical office space that 

satisfies the ‘‘same building’’ test in 

§ 411.355(b)(2)(i) of this chapter for 

purposes of the physician self-referral 

rules in Part 411, Subpart J of this 

chapter and other medical office space 

in which patients are seen and that 

complies with the physician self-referral 

rules are subject to the anti-markup 

provisions in revised § 414.50. That is, 

physician groups allege that, in 

situations in which they are subject to 

the anti-markup provisions and are 

limited to billing Medicare for the 

amount of the net charge imposed by 

the performing supplier, because they 

will not be able to realize a profit and 

will not be able to recoup their overhead 

costs, they will not be able to continue 

to provide diagnostic testing services to 

the same extent that they are currently 

providing such services. 

We are concerned that the definition 

of ‘‘office of the billing physician or 

other supplier’’ may not be entirely 

clear and could have unintended 

consequences. Accordingly, in order for 

us to study the issues further, we are 

delaying until January 1, 2009, the 

applicability of the revised anti-markup 

provisions in § 414.50, except for 

anatomic pathology diagnostic testing 

services furnished in space that: (1) Is 

utilized by a physician group practice as 

a ‘‘centralized building’’ (as defined at 

§ 411.351 of this chapter) for purposes 

of complying with the physician selfreferral rules; and (2) does not qualify as 

a ‘‘same building’’ under 

§ 411.355(b)(2)(i) of this chapter. During 

the next 12 months, we plan to issue 

clarifying guidance as to what 

constitutes the ‘‘office of the billing 

physician or other supplier’’ or propose 

additional rulemaking, or both. Because 

anatomic pathology diagnostic testing 

arrangements precipitated our proposal 

for revision of the anti-markup 

provisions and remain our core concern, 

we are not delaying the date of 

applicability with respect to anatomic 

pathology diagnostic testing services 

furnished in space that: (1) Is utilized by 

a physician group practice as a 

‘‘centralized building’’ (as defined at 

§ 411.351 of this chapter) for purposes 

of complying with the physician selfreferral rules; and (2) does not qualify as 

a ‘‘same building’’ under 

§ 411.355(b)(2)(i) of this chapter. In 

addition, we are not delaying the 

applicability of the revised anti-markup 

rule with respect to the technical 

component of any purchased diagnostic 

test. The anti-markup prohibition with 

respect to the technical component of 

purchased diagnostic tests is 

longstanding and was incorporated into 

the expanded and revised provision of 

§ 414.50. Accordingly, it will remain 

applicable to the technical component 

of any purchased diagnostic test. 

III. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking and invite public 

comment on the proposed rule. The 

notice and comment rulemaking 

procedure is not required, however, if 

the rule is interpretive or procedural in 

nature, and it may be waived if there is 

good cause that it is impracticable, 

unnecessary, or contrary to the public 

interest and we incorporate in the rule 

a statement of such a finding and the 

reasons supporting that finding. 

Likewise, we ordinarily provide for a 

delayed effective date of a final rule, but 

we are not required to do so if the rule 

is procedural or interpretive. Where a 

delayed effective date is required, this 

requirement may be waived for good 

cause. We set forth below our finding of 

good cause for the waiver of notice and 

comment rulemaking and the waiver of 

a delayed effective date. 

Our implementation of this action 

without opportunity for public 

comment and without a delayed 

effective date is based on the good cause 

exceptions in 5 U.S.C. 553(b)(3)(B) and 

(d), respectively. We find that seeking 

public comment on this action is 

impracticable and contrary to the public 

interest. We are implementing this delay 

of effective date as a result of our review 

of the informal comments on the final 

rule with comment period from various 

stakeholders. As discussed above, we 

understand from those comments that 

patient access for common diagnostic 

tests may be significantly disrupted 


jlentini on PROD1PC65 with RULES
406 Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Rules and Regulations 

unless we delay the effective date of 

revised § 414.50 with respect to 

anatomic pathology diagnostic testing 

services furnished in space that: (1) Is 

utilized by a physician group practice as 

a ‘‘centralized building’’ (as defined at 

§ 411.351 of this chapter) for purposes 

of complying with the physician selfreferral rules; and (2) does not qualify as 

a ‘‘same building’’ under 

§ 411.355(b)(2)(i) of this chapter. 

Likewise, if we do not make this final 

rule effective upon publication, patient 

care may be significantly disrupted 

during the interim period between the 

issuance of the rule and a delayed 

effective date. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

V. Regulatory Impact Statement 

We do not believe that this delay in 

the date of applicability will result in 

any significant economic impact on any 

small entity. Until January 1, 2009, the 

majority of billing suppliers affected by 

the revised § 414.50 do not have to 

comply with the revised requirements 

in § 414.50. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 18, 2007. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: December 27, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–6280 Filed 12–28–07; 1:17 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Parts 600 and 622 

[Docket No. 070518142–7238–02] 

RIN 0648–AV45 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; Gulf of 

Mexico Vermilion Snapper Fishery 

Management Measures 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS issues this final rule to 

implement a regulatory amendment to 

the Fishery Management Plan for the 

Reef Fish Resources of the Gulf of 

Mexico (FMP) prepared by the Gulf of 

Mexico Fishery Management Council 

(Council). This final rule reduces the 

minimum size limit for vermilion 

snapper to 10 inches (25.4 cm) total 

length (TL), eliminates the 10–fish 

recreational bag limit for vermilion 

snapper within the existing 20–fish 

aggregate reef fish bag limit, and 

eliminates the 40-day commercial 

closed season for vermilion snapper 

(from April 22 through May 31 each 

year). NMFS is also implementing 

through this rule clarifications for the 

Gulf of Mexico red snapper individual 

fishing quota (IFQ) program, as well as 

non-substantive changes to codified 

text, including removing obsolete 

language regarding the use of fish traps 

in the Gulf of Mexico, removing 

outdated and redundant language, 

revising phone numbers and an 

outdated definition, and revising 

incorrect references. The intended 

effects of this final rule are to help 

achieve optimum yield (OY) by 

reducing vermilion snapper harvest 

limitations consistent with the findings 

of the recent stock assessment and to 

clarify and update existing regulations. 

DATES: This rule is effective February 4, 

2008, except for the amendments 

to§ 622.16(c)(3)(i) and (ii) which are 

effective January 3, 2008 and the 

amendment to § 622.39(b)(1)(x) which is 

effective February 4, 2008 through 

March 28, 2008. 

ADDRESSES: Copies of the final 

regulatory flexibility analysis (FRFA) 

may be obtained from Sarah DeVido, 

NMFS, Southeast Regional Office, 263 

13th Avenue South, St. Petersburg, FL 

33701; telephone 727–824–5305; fax 

727–824–5308; email 

sarah.devido@noaa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Sarah DeVido, telephone 727–824–5305; 

fax 727–824–5308; e-mail 

sarah.devido@noaa.gov. 

SUPPLEMENTARY INFORMATION: The reef 

fish fishery of the Gulf of Mexico is 

managed under the FMP. The FMP was 

prepared by the Council and is 

implemented through regulations at 50 

CFR part 622 under the authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act). 

In accordance with the FMP’s 

framework procedure, the Council 

recommended, and NMFS published, a 

proposed rule to implement the 

regulatory amendment and requested 

public comment through May 14, 2007 

(72 FR 20980, April 27, 2007). The 

rationale for the measures contained in 

the regulatory amendment, is provided 

in the preamble to the proposed rule 

and the responses to comment below 

and is not repeated here. A summary of 

the public comments received by NMFS 

on the proposed rule and NMFS’

responses are provided below. 

Comments and Responses 

A total of 83 individuals submitted 

comments during the comment period 

on the proposed rule to reduce the size 

limit, relax the recreational bag limit, 

and remove a commercial closure. Of 

these, 68 of the commenters expressed 

support for one, two or all three of the 

proposed actions, and did not express 

any specific objections. The remaining 

15 commenters opposed one or more of 

the proposed actions. 

Comment 1: The regulations for 

vermilion snapper should remain as 

they are. Of special concern is the 

proposal to remove the 10–fish bag limit 

restriction. Such an action is not in line 

with a conservation-oriented approach 

to recreational fishing. The upcoming 

reductions in bag limits for red snapper 

and gray triggerfish may cause an effort 

shift to vermilion snapper, which could 

lead to increased harvests of this 

species. Optimistic assumptions 

regarding current low fishing mortality 

should not be relied upon. Effort shifts 

could substantially increase fishing 

mortality, and the regulations would 

have to be revised to ensure the 

vermilion snapper stock does not 

become overfished or undergo 

overfishing. 

Response: Fishery stocks should be 

managed conservatively, with a goal of 

achieving optimum yield (OY) from the 

fishery. The 2006 stock assessment for 

vermilion snapper incorporated new 


jlentini on PROD1PC65 with RULES