Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 75557 

estimated to be 34,125 hours (13,650 x 

2.5 hours). 

FDA received 89,990 new foreign 

facility registrations during 2003; 49,574 

during 2004; and 29,193 during 2005. 

Based on this experience, FDA estimates 

the annual number of new foreign 

facility registrations will be 29,200. FDA 

estimates that listing the information 

required by the Bioterrorism Act and 

presenting it in a format that will meet 

the agency’s registration regulations will 

require a burden of approximately 8.5 

hours per average foreign facility 

registration. The average foreign facility 

burden hour estimate of 8.5 hours 

includes an estimate of the additional 

burden on a foreign facility to obtain a 

U.S. agent, and takes into account that 

for some foreign facilities the 

respondent completing the registration 

may not be fluent in English and/or not 

have readily available Internet access. 

Thus, the total annual burden for new 

foreign facility registrations is estimated 

to be 248,200 hours (29,200 x 8.5 hours). 

FDA received 131,354 updates to 

facility registrations during 2003; 

137,384 during 2004; and 92,835 during 

2005. Based on this experience, FDA 

estimates that it will receive 92,850 

updates annually. FDA also estimates 

that updating a registration will, on 

average, require a burden of 

approximately 1 hour, taking into 

account fluency in English and Internet 

access. Thus, the total annual burden for 

updating all registrations is estimated to 

be 92,850 hours. 

FDA received 12,556 cancellations of 

facility registrations during 2003; 7,467 

during 2004; and 1,280 during 2005. 

Based on this experience, FDA estimates 

the annual number of cancellations will 

be 1,300. FDA also estimates that 

cancelling a registration will, on 

average, require a burden of 

approximately 1 hour, taking into 

account fluency in English and Internet 

access. Thus, the total annual burden for 

cancelling registrations is estimated to 

be 1,300 hours. 

In cases where a regulation 

implements a statutory information 

collection requirement, only the 

additional burden attributable to the 

regulation, if any, has been included in 

FDA’s burden estimate. 

Dated: December 11, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–21375 Filed 12–14–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0476] 

Drug Products Containing Quinine; 

Enforcement Action Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to take enforcement action 

against unapproved drug products 

containing quinine (including quinine 

sulfate and any other salt of quinine) 

and persons who cause the manufacture 

of such products or their shipment in 

interstate commerce. Drug products 

containing quinine, quinine sulfate, and 

any other salt of quinine are new drugs 

that require approved applications. One 

firm has an approved application to 

market a drug product containing 

quinine sulfate to treat malaria; this 

product has been designated an orphan 

drug product. Other manufacturers who 

wish to market a drug product 

containing quinine, quinine sulfate, or 

any other salt of quinine must obtain 

FDA approval of a new drug application 

(NDA) or an abbreviated new drug 

application (ANDA); consideration of 

any such applications will be subject to 

the rights of the current NDA holder 

under the Orphan Drug Act. 

DATES: This notice is effective December 

15, 2006. 

For marketed, unapproved drug 

products containing quinine, quinine 

sulfate, or any salt of quinine that have 

a National Drug Code (NDC) number 

that is listed with FDA on the effective 

date of this notice (i.e., ‘‘currently 

marketed products’’), however, the 

agency intends to exercise its 

enforcement discretion to permit 

products marketed with those NDC 

numbers a brief period of continued 

marketing after December 15, 2006 as 

follows. Any firm manufacturing such 

an unapproved product may not 

manufacture that product on or after 

February 13, 2007. Any firm distributing 

such an unapproved product may not 

ship the product in interstate commerce 

on or after June 13, 2007. Unapproved 

drug products containing quinine, 

quinine sulfate, or any salt of quinine 

that are not currently marketed products 

on the effective date of this notice must, 

as of the effective date of this notice, 

have approved applications prior to 

their shipment in interstate commerce. 

Submission of an application does not 

excuse timely compliance with this 

notice. 

ADDRESSES: All communications in 

response to this notice should be 

identified with Docket No. 2006N–0476 

and directed to the appropriate office 

listed as follows: 

Regarding applications under section 

505(b) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 

U.S.C. 355(b)): Division of Special 

Pathogen and Transplant Products, 

Office of New Drugs, Center for 

Drug Evaluation and Research, 

Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 

22, Silver Spring, MD 20993–0002. 

Regarding applications under section 

505(j) of the act: Office of Generic 

Drugs, Center for Drug Evaluation 

and Research (HFD–600), Food and 

Drug Administration, 7520 Standish 

Pl., Rockville, MD 20855. 

All other communications: John Loh, 

Center for Drug Evaluation and 

Research (HFD–310), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: John 

Loh, Center for Drug Evaluation and 

Research (HFD–310), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–8965, email: john.loh@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Quinine is the chief alkaloid of 

cinchona, the bark of the cinchona tree 

indigenous to parts of South America. 

Recorded medical use of cinchona dates 

back to the 17th century. Quinine was 

first isolated from cinchona in 1820. 

Quinine (the term ‘‘quinine’’ as used in 

this notice refers to quinine, quinine 

sulfate, and other quinine salts) has 

been used to treat malaria since the 19th 

century. It was used extensively for 

mass prophylaxis in malaria control 

programs in the early 20th century. As 

more predictable and effective synthetic 

antimalarial drugs began to be 

developed in the 1930s, the use of 

quinine to treat and/or prevent malaria 

declined. However, with the increasing 

resistance of the malaria parasite to 

some of these synthetic malarial 

treatments, quinine is again emerging as 

an important treatment for malaria. 

Quinine also has been used for the 

treatment and/or prevention of 

nocturnal leg muscle cramps, similar 

conditions such as a restless leg 

syndrome, and, very rarely, a number of 

other conditions, including Babesiosis 

(another parasitic infection) and certain 

myotonic disorders. The predominant 

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75558 Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 

1Serious adverse reactions include the following 

outcomes: Death, a life-threatening adverse drug 

experience, inpatient hospitalization or 

prolongation of existing hospitalization, a persistent 

or significant disability/incapacity, a congenital 

anomaly/birth defect, or an important medical 

event that may jeopardize the patient and may 

require medical or surgical intervention to prevent 

one of the other mentioned serious outcomes 

(§ 314.80 (21 CFR 314.80)). 

2The term ‘‘orphan drug’’ refers to a product that 

treats a rare disease affecting fewer than 200,000 

Americans. Enacted in 1983, the intent of the 

Orphan Drug Act is to stimulate the research, 

development, and approval of products that treat 

rare diseases. Under this law, which amended the 

act and is provided in 21 U.S.C. 360aa to 360ee, a 

firm that receives approval for a product designated 

as an orphan drug receives for the product a special 

period of exclusivity of 7 years after the date of 

approval, during which the agency will not approve 

another application for the same drug, as defined 

in 21 CFR 316.3, for the same condition submitted 

by another applicant. 

use of quinine in the United States is for 

leg cramps and similar conditions. 

Quinine has a history of being 

marketed over-the-counter (OTC) and by 

prescription, as a single-ingredient 

product or sometimes in combination 

with other ingredients, such as vitamin 

E. Its use as a treatment for leg cramps 

and as an antimalarial agent was 

considered in the OTC drug monograph 

review. In the Federal Register of 

August 22, 1994 (59 FR 43234), the 

agency announced its conclusion that 

OTC drug products for the treatment 

and/or prevention of nocturnal leg 

muscle cramps are not generally 

recognized as safe and effective 

(GRASE), and are therefore new drugs 

under section 201(p) of the act (21 

U.S.C. 321(p)). In reaching this 

conclusion, the agency reviewed 

extensive information from studies and 

adverse drug events reported to the 

agency regarding the safety and efficacy 

of products containing quinine sulfate. 

The agency identified numerous safety 

concerns associated with use of quinine 

sulfate (59 FR 43234 at 43235 through 

43244). Further, the agency’s review 

assessed the effectiveness of quinine 

sulfate for prevention and/or treatment 

of leg cramps, and concluded that the 

data were not adequate to establish that 

quinine sulfate, alone or in combination 

with vitamin E, is effective for these 

uses (59 FR 43234 at 43245 through 

43249). The agency’s conclusions 

regarding OTC drug products containing 

quinine indicated for treatment or 

prevention of nocturnal legs cramps are 

provided in 21 CFR 310.546. 

Subsequently, in the Federal Register 

of March 20, 1998 (63 FR 13526), the 

agency announced its conclusions 

regarding OTC drug products containing 

quinine or any quinine salt (e.g., 

quinine sulfate) labeled for the 

treatment and/or prevention of malaria. 

Because of the safety issues associated 

with these products, the agency 

concluded that these OTC products are 

not generally recognized as safe (GRAS) 

and are therefore new drugs as well. The 

agency’s conclusions regarding OTC 

drug products containing quinine 

indicated for treatment or prevention of 

malaria are provided in 21 CFR 310.547. 

II. Safety Issues in Use of Quinine Drug 

Products 

Serious safety concerns, including 

fatalities, associated with drug products 

containing quinine are welldocumented in the literature and in 

adverse drug events reported to the 

agency. One of these adverse events is 

quinine toxicity, which is known as 

cinchonism, a cluster of symptoms of 

varying severity that include tinnitus, 

dizziness, disorientation, nausea, visual 

changes, and auditory deficits. There 

also is evidence that quinine causes QT 

prolongation and serious cardiac 

arrhythmias including torsades de 

pointes. People taking quinine are at 

risk of developing hypersensitivity to 

the drug and experiencing a serious, 

life-threatening, or fatal reaction as a 

consequence. Serious adverse reactions 

associated with quinine use also include 

severe skin reactions, thrombocytopenia 

and other serious hematological events, 

permanent visual and hearing 

disturbances, hypoglycemia, and 

generalized anaphylaxis. Overall, from 

1969 through September 11, 2006, FDA 

received 665 reports of adverse events 

with serious outcomes associated with 

quinine use, including 93 deaths. 

Among the more common types of 

events with serious outcomes reported 

to the agency are cardiac events, 

thrombocytopenia, renal failure, 

hypersensitivity/skin reactions, 

ophthalmologic events, hearing 

disorders, and thrombotic 

thrombocytopenic purpura (TTP).1

Further, quinine sulfate is known to 

have a narrow therapeutic index, with a 

very narrow margin of safety between 

doses that are therapeutic in the 

treatment of malaria and doses that are 

toxic. Many of the adverse events 

associated with quinine are dose-related 

(63 FR 15526 at 13527). Overdosing of 

quinine sulfate can result in cardiac 

arrhythmia, ototoxicity, blindness, or 

death. The rate of clearance of quinine 

sulfate tends to decline with age, 

meaning the blood level of quinine 

tends to be higher for a longer period of 

time in the elderly for a given dose 

compared to younger persons and the 

frequency and severity of adverse effects 

may also be greater in the elderly (63 FR 

13526 at 13527). 

III. Current Status of Quinine Drug 

Products 

Mutual Pharmaceutical Company, 

Inc., (Mutual), of Philadelphia, PA, 

submitted an NDA for single-ingredient 

quinine sulfate in 324-milligram 

capsules (NDA 21–799), which was 

approved by FDA on August 12, 2005. 

The product is approved to treat 

uncomplicated Plasmodium falciparum 

malaria only and is a prescription drug 

product. 

NDA 21–799 is the only approved 

application for a product containing 

quinine. Because the incidence of 

malaria in the United States is rare, 

Mutual sought and was granted orphan 

drug status for its product under section 

526 of the act (21 U.S.C. 360bb).2

The approved labeling for Mutual’s 

quinine sulfate product provides 

extensive warnings regarding the use of 

the product. It states that the product is 

not approved for the prevention or 

treatment of nocturnal leg cramps and 

explicitly warns against the use of the 

product for these indications. It 

describes findings related to use of 

quinine sulfate and QT interval 

prolongation, along with the association 

of the drug with potentially fatal cardiac 

arrhythmias. The labeling 

contraindicates use of the product in 

patients with prolonged QT interval, G6-PD deficiency, optic neuritis, 

myasthenia gravis, and known 

hypersensitivity to quinine or related 

drugs. The labeling also identifies 

numerous drugs that should not be used 

concomitantly with quinine, including 

neuromuscular blocking agents, 

rifampin, class IA and III antiarrhythmic 

agents, HISMANIL (astemizole), 

PROPULSID (cisapride), erythromycin, 

and other medications known to cause 

QT prolongation. 

Because of the risks associated with 

use of quinine sulfate, Mutual agreed, as 

part of the approval of its product, to 

implement an educational program for 

physicians and other health care 

providers regarding the safe and 

effective use of quinine sulfate for 

treatment of uncomplicated P. 

falciparum malaria. The firm also 

agreed to provide written information to 

physicians regarding the unfavorable 

risk/benefit ratio of oral quinine sulfate 

for treatment of nocturnal leg cramps, as 

compared with the favorable risk/ 

benefit ratio for treatment of 

uncomplicated P. falciparum malaria. 

For 3 years following approval, Mutual 

will also provide the agency with twiceyearly analyses of postmarketing 

adverse event data, in addition to 15- 

day and quarterly reports required 

under § 314.80(c)(1) and (c)(2). 

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Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 75559 

3The agency’s general approach in dealing with 

these products in an orderly manner is spelled out 

in the Marketed Unapproved Drugs CPG. However, 

this CPG provides notice that any product that is 

being marketed illegally, and the persons 

responsible for causing the illegal marketing of the 

product, are subject to FDA enforcement action at 

any time. 

4If a firm continues to manufacture or market a 

product covered by this notice after the applicable 

enforcement date has passed, to preserve limited 

agency resources, FDA may take enforcement action 

relating to all of the firm’s unapproved drugs that 

require applications at the same time. (See, e.g., 

United States v. Sage Pharmaceuticals, 210 F.3d 

475, 479–480 (5th Cir. 2000) (permitting the agency 

to combine all violations of the act in one 

proceeding, rather than taking action against a firm 

with multiple violations of the act in ‘‘piecemeal 

fashion’’).) 

Unapproved quinine sulfate products 

are also available on the market. The 

agency reviewed the labeling of 

unapproved quinine products listed 

with FDA under the requirement of 

section 510(j) of the act (21 U.S.C. 

360(j)). In general, labeling for the 

unapproved products does not contain 

many of the warnings found in the 

approved product labeling and therefore 

does not reflect the most current data 

regarding quinine sulfate. For instance, 

unapproved products typically do not 

provide information about prolongation 

of the QT interval, warn against use of 

the product to treat leg cramps, or 

identify many of the contraindications 

and drug interactions for quinine sulfate 

products. The agency also reviewed 

dosing regimens recommended in the 

labeling of unapproved quinine sulfate 

products and found that many of the 

recommend dosing regimens, for which 

supporting evidence has not been 

evaluated by the agency, are 

inconsistent with the dosing 

recommendations for the approved 

product, which are based on clinical 

evidence. These regimens, at one end of 

the spectrum of recommended doses, 

could lead to substantial underdosing, 

risking treatment failure, and promoting 

the development of malarial resistance 

to quinine, and, at the other end of the 

spectrum, could lead to overdosing, 

increasing the risk of serious adverse 

events, and death. 

IV. Legal Status 

A. Quinine Products Are New Drugs 

Requiring Approved Applications 

Based on the safety and effectiveness 

considerations described previously, 

drugs containing quinine, quinine 

sulfate, or any other salt of quinine are 

not GRASE for the treatment or 

prevention of malaria, leg cramps, or 

any other condition under section 

201(p) of the act. Therefore, a drug 

product containing any of these 

ingredients, alone or in combination 

with other drugs, is regarded as a new 

drug as defined in section 201(p) of the 

act and is subject to the requirements of 

section 505 of the act. An approved 

application is required to market the 

product. As set forth in this notice, 

approval of an NDA under section 

505(b) of the act (including section 

505(b)(2)) and 21 CFR 314.50 or an 

ANDA under section 505(j) of the act 

and 21 CFR 314.94 is required as a 

condition for manufacturing or 

marketing all quinine products. After 

the dates identified in this notice (see 

DATES), FDA intends to take 

enforcement action, as described in this 

notice, against unapproved drug 

products containing quinine and 

persons who cause the manufacture or 

interstate shipment of such products. 

Submission of an application does not 

excuse timely compliance with this 

notice. 

The Mutual quinine sulfate product 

(NDA 21–799) described in section III of 

this notice has been designated as the 

reference listed drug product. Firms 

should be aware that review and 

approval of any applications for quinine 

products will be subject to the rights of 

the current NDA holder under the 

Orphan Drug Act, including section 527 

of the act (21 U.S.C. 360cc) and FDA’s 

regulations in 21 CFR part 316. 

B. Notice of Enforcement Action 

Although not required to do so by the 

Administrative Procedure Act, the act, 

or any rules issued under its authority, 

or for any other legal reason, FDA is 

providing this notice to firms that are 

marketing drug products containing 

quinine without an approved 

application that the agency intends to 

take enforcement action against such 

products and those who cause them to 

be manufactured or shipped in 

interstate commerce. Consistent with 

the priorities identified in the agency’s 

guidance entitled ‘‘Marketed 

Unapproved Drugs—Compliance Policy 

Guide’’ (the Marketed Unapproved 

Drugs CPG), the agency is taking action 

at this time against unapproved quinine 

products because: (1) As described in 

section II of this notice, quinine is a 

drug with significant safety risks; and 

(2) the agency has approved an 

application to market a drug product 

containing quinine sulfate, and thus the 

continued marketing of unapproved 

quinine products is a direct challenge to 

the drug approval process. 

Manufacturing or shipping unapproved 

quinine products can result in seizure, 

injunction, or other judicial proceeding. 

Consistent with policies described in 

the Marketed Unapproved Drugs CPG, 

the agency does not expect to issue a 

warning letter or any other further 

warning to firms marketing unapproved 

drug products containing quinine prior 

to taking enforcement action. The 

agency also reminds firms that, as stated 

in the Marketed Unapproved Drugs 

CPG, any unapproved drug marketed 

without a required approved drug 

application is subject to agency 

enforcement action at any time. The 

issuance of this notice does not in any 

way obligate the agency to issue similar 

notices or any notice in the future 

regarding marketed unapproved drugs.3

As described in the Marketed 

Unapproved Drugs CPG, the agency 

may, at its discretion, exercise its 

enforcement discretion and identify a 

period of time during which the agency 

does not intend to initiate an 

enforcement action against a currently 

marketed unapproved drug on the 

grounds that it lacks an approved 

application under section 505 of the act, 

to preserve access to medically 

necessary drugs, or ease disruption to 

affected parties, for instance. The 

agency notes the following: (1) Quinine 

is a drug with significant safety risks 

that are comprehensively described only 

in the labeling of the approved product; 

(2) the most common use of quinine is 

an off-label use for which the drug has 

an unfavorable risk-benefit profile, 

which is described in the labeling of the 

approved product, but not the 

unapproved products; (3) Mutual can 

provide the market with enough 

approved quinine sulfate to meet 

patients’ needs for the approved 

indications; and (4) Mutual has now 

obtained approval of its quinine sulfate 

product. Therefore, the agency intends 

to proceed as follows. 

This notice is effective December 15, 

2006. Unapproved drug products 

containing quinine, quinine sulfate, or 

any salt of quinine that are not currently 

marketed products on the effective date 

of this notice must, as of this date, have 

approved applications prior to their 

shipment in interstate commerce. For 

marketed, unapproved quininecontaining products that have an NDC 

number that is listed with the agency on 

the effective date of this notice, 

however, the agency intends to exercise 

its enforcement discretion to permit 

products marketed with those NDC 

numbers a period of continued 

marketing after December 15, 2006 as 

follows. Any firm manufacturing such 

an unapproved drug product containing 

quinine may not manufacture that 

product on or after February 13, 2007.4

Any firm distributing such an 

unapproved product may not ship the 

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75560 Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 

product in interstate commerce on or 

after June 13, 2007. The agency, 

however, does not intend to exercise its 

enforcement discretion as outlined in 

this paragraph if: (1) A manufacturer or 

distributor of an unapproved product 

covered by this notice is violating other 

provisions of the act; or (2) it appears 

that a firm, in response to this notice, 

increases its manufacture or interstate 

shipment of quinine drug products 

above its usual volume during these 

periods. 

Drug manufacturers and distributors 

should be aware that the agency is 

exercising its enforcement discretion as 

described previously only in regard to 

drug products containing quinine that 

are marketed under an NDC number 

listed with the agency on the effective 

date of this notice. Unapproved drug 

products containing quinine that are not 

currently marketed and listed with the 

agency on the effective date of this 

notice must, as of the effective date of 

this notice, have approved applications 

prior to their shipment in interstate 

commerce. Moreover, submission of an 

application does not excuse timely 

compliance with this notice. 

C. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

its NDC number(s), and stating that the 

product(s) has (have) been discontinued 

and will not be marketed again without 

FDA approval, to John Loh (see 

ADDRESSES). Firms should also update 

the listing of their products under 

section 510(j) of the act to reflect 

discontinuation of unapproved quinine 

products. FDA plans to rely on its 

existing records, the results of a 

subsequent inspection, or other 

available information when it initiates 

enforcement action. 

This notice is issued under sections 

502 and 505 of the act (21 U.S.C. 352) 

and under authority delegated to the 

Deputy Commissioner for Policy under 

section 1410.10 of the FDA Staff Manual 

Guide. 

Dated: December 11, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–9713 Filed 12–12–06; 11:00 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0493] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization Scheduling 

Recommendations for Dronabinol and 

its Stereoisomers, and Oripavine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

interested persons with the opportunity 

to submit written comments concerning 

recommendations by the World Health 

Organization (WHO) to impose 

international manufacturing and 

distributing restrictions, under 

international treaties, on certain drug 

substances. The comments received in 

response to this notice will be 

considered in preparing the U.S. 

position on these proposals for a 

meeting of the United Nations 

Commission on Narcotic Drugs (CND) in 

Vienna, Austria, March 12 to 16, 2007. 

This notice is issued under the 

Controlled Substances Act. 

DATES: Submit written or electronic 

comments by January 16, 2007. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research (HFD–9), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–443–

5563, e-mail: james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (the 1971 Convention). 

Section 201(d)(2)(B) of the Controlled 

Substances Act (the CSA) (21 U.S.C. 

811(d)(2)(B)) provides that when the 

United States is notified under Article 2 

of the 1971 Convention that CND 

proposes to decide whether to add a 

drug or other substance to one of the 

schedules of the 1971 Convention, 

transfer a drug or substance from one 

schedule to another, or delete it from 

the schedules, the Secretary of State 

must transmit notice of such 

information to the Secretary of Health 

and Human Services (the Secretary of 

HHS). Section 201(d)(2)(B) requires the 

Secretary of HHS, after receiving 

notification proposing scheduling, to 

publish a summary of such information 

in the Federal Register to provide 

opportunity for interested persons to 

submit comments on the proposed 

scheduling action. The Secretary of HHS 

must then evaluate the proposal and 

furnish a recommendation to the 

Secretary of State that shall be binding 

on the representative of the United 

States in discussions and negotiations 

relating to the proposal. 

As detailed in the following 

paragraphs, the Secretary of State has 

received notification from the SecretaryGeneral of the United Nations (the 

Secretary-General) regarding the drug 

substance dronabinol (INN), including 

its stereoisomers, to be considered for 

control under the 1971 Convention. The 

notification reflects the 

recommendations from the 34th WHO 

Expert Committee for Drug Dependence 

(ECDD), which met in March 2006. In 

the Federal Register of December 13, 

2005 (70 FR 73775), FDA announced the 

WHO ECDD review and invited 

interested persons to submit 

information for WHO’s consideration. 

The United States is also a party to 

the 1961 Single Convention on Narcotic 

Drugs (the 1961 Convention). The 

Secretary of State has received 

notification from the Secretary-General 

regarding the drug substance oripavine 

to be considered for control under the 

1961 Convention. The CSA does not 

require the Secretary of HHS to publish 

a summary of such information in the 

Federal Register. Nevertheless, in an 

effort to provide interested and affected 

persons an opportunity to submit 

comments on the WHO ECDD 

recommendations for narcotic drugs, 

notification on this substance is also 

included in this Federal Register notice. 

The comments will be shared with other 

relevant agencies to assist the Secretary 

of State in formulating the U.S. position 

on the control of these substances. The 

HHS recommendations are not binding 

on the representative of the United 

States in discussions and negotiations 

relating to the proposal on control of 

substances under the 1961 Convention. 

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