Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 12059 

Type of respondent Form name Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total annual 

burden in 

hours 

Total ........................................... ........................................................... ........................ ........................ ........................ 1735 

Kimberly S. Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–4566 Filed 2–27–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0171] 

Using Innovative Technologies and 

Other Conditions of Safe Use To 

Expand Which Drug Products Can Be 

Considered Nonprescription; Public 

Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The U.S. Food and Drug 

Administration (FDA or the Agency) is 

announcing a public hearing to obtain 

input on a new paradigm we are 

considering. Under this paradigm, the 

Agency would approve certain drugs 

that would otherwise require a 

prescription for nonprescription use 

(also known as over-the-counter or OTC) 

under conditions of safe use. These 

conditions of safe use would be specific 

to the drug product and might require 

sale in certain pre-defined health care 

settings, such as a pharmacy. This 

public hearing is being held to obtain 

information and comments from the 

public on the feasibility of this 

paradigm and its potential benefits and 

costs. 

DATES: Public Hearing: The public 

hearing will be held on March 22 and 

23, 2012, from 9 a.m. to 4 p.m. The 

meeting may be extended or may end 

early depending on the level of public 

participation. 

Presentations and Comments: Submit 

either electronic or written requests for 

oral presentations and comments by 

March 9, 2012. (See section IV of this 

document for details.) Either electronic 

or written comments will be accepted 

after the hearing until May 7, 2012 (See 

section VI of this document for details.) 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Rm. 1503, Silver Spring, MD, 20993– 

0002. 

Comments and Transcripts: Submit 

either electronic or 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.

regulations.gov. All comments should 

be identified with the docket number 

found in brackets in the heading of this 

document. Transcripts of the hearing 

will be available for review at the 

Division of Dockets Management and on 

the Internet at http://www.

regulations.gov approximately 45 days 

after the hearing. 

FOR FURTHER INFORMATION CONTACT: Lee 

Lemley, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20903–0002, 

301–796–3441, Fax: 301–847–8753, 

email: OTCTechnologiesPublic

Meeting@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public hearing to obtain 

input on a potential new paradigm 

under which the Agency would approve 

certain drugs that would otherwise 

require a prescription for 

nonprescription use under conditions of 

safe use specific to the drug product. 

Some drugs approved in this manner 

might require sale in certain pre-defined 

health care settings, such as a pharmacy. 

I. Background 

A. Prescription and Nonprescription 

Drugs 

Under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), FDA 

approves new drugs under section 505 

(21 U.S.C. 355) either as prescription or 

nonprescription. Under section 

503(b)(1)(A) of the FD&C Act (21 U.S.C. 

353(b)(1)(A)), a drug must be dispensed 

by prescription if, ‘‘because of its 

toxicity or other potentiality for harmful 

effect, or the method of its use, or the 

collateral measures necessary to its use, 

[it] is not safe for use except under the 

supervision of a practitioner licensed by 

law to administer such drug.’’ Under 

sections 505(d)(1) and (d)(4), FDA has 

considerable latitude in determining 

whether the information submitted as 

part of a new drug application (NDA) is 

sufficient to ensure that a drug is safe 

for use under its proposed labeling. FDA 

also makes a determination under 

503(b) as to whether the product meets 

the criteria for prescription-only 

dispensing. 

Prescription drugs are dispensed 

upon receipt of a prescription from a 

practitioner licensed by law to 

administer the drug (which may include 

health care professionals such as 

physicians, nurse practitioners, 

physician’s assistants, and others whom 

we will refer to here as practitioners or 

prescribers). (See 21 U.S.C. 353(b).) In 

many instances, under the current 

regulatory system, a patient has to 

obtain at least the initial prescription, 

and in some cases, prescription refills, 

from a practitioner through an in person 

interaction. Obtaining a refill for other 

prescription drugs involves at least a 

telephone call or other communication 

with the practitioner. In contrast, 

nonprescription drugs (sometimes 

referred to as over-the-counter or OTC 

products) can be purchased by 

consumers in pharmacies, 

supermarkets, and other retail 

establishments without the need for a 

prescription. Currently, consumers can 

purchase nonprescription drugs from a 

retailer for diseases or conditions that 

do not meet the statutory criteria for 

prescription products and that are safe 

and effective for use in self-medication 

as directed in the labeling. (See 21 

U.S.C. 353(b).) Generally, OTC products: 

(1) Are available to treat diseases or 

conditions that can be self-diagnosed 

without a prior interaction with a 

practitioner, (2) are not associated with 

toxicities that require an evaluation of 

the benefits and risks by a practitioner; 

and (3) do not require a practitioner’s 

input for use. 

B. Undertreatment of Diseases and 

Other Effects on the Health Care System 

Undertreatment of many common 

diseases or conditions in the United 

States is a well recognized public health 

problem. Increasing the number of 

people who are able to obtain for the 

first time and those who continue on 

necessary drug therapy could provide 

improved health outcomes. The 

requirement to obtain a prescription for 

appropriate medication (and to make 

one or more visits to a practitioner) may 

contribute to undertreatment of certain 

common medical conditions including 


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12060 Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 

hyperlipidemia (high cholesterol), 

hypertension (high blood pressure), 

migraine headaches, and asthma. For 

instance, some consumers do not seek 

necessary medical care, which may 

include prescription drug therapy, 

because of the cost and time required to 

visit a health care practitioner for an 

initial diagnosis and an initial 

prescription. Some patients who obtain 

an initial prescription do not continue 

on necessary medication because they 

would need to make additional visits to 

a health care practitioner for a 

prescription refill after any refills 

authorized by the initial prescription 

have been used or the time during 

which they can be filled has expired. 

Some prescription medications require 

routine monitoring through the 

prescribing practitioner such as blood 

tests to assist in the diagnosis of a 

condition, or to determine whether or 

how well the medication is working, or 

to adjust the dose. FDA believes that 

some of these visits could be eliminated 

by making certain prescription 

medications available without a 

prescription but with certain other 

conditions of safe use that would ensure 

they could be used safely and effectively 

without the initial involvement of a 

health care practitioner. In some cases, 

a visit to a practitioner would be 

required for the initial prescription, but 

a certain number of refills could be 

authorized beyond those that would 

normally be authorized without a return 

visit under specialized conditions of 

safe use. This paradigm might be useful 

for certain rescue medicines, such as 

inhalers used to treat asthma or 

epinephrine for allergic reactions, that 

patients need to keep on hand for use 

in emergencies. In addition to improved 

health outcomes for consumers staying 

on their medications, the time and 

attention that physicians and other 

health care providers expend on routine 

tasks related to prescription refills 

reduces the time that they are available 

to attend to more seriously ill patients. 

Eliminating or reducing the number of 

routine visits could free up prescribers 

to spend time with more seriously ill 

patients, reduce the burdens on the 

already overburdened health care 

system, and reduce health care costs. 

II. New Paradigm 

FDA is considering whether 

medications for certain diseases or 

conditions that would otherwise be 

available only by prescription could be 

made available without a prescription 

with certain conditions of safe use. For 

example, some conditions of safe use 

could be designed to assist patients in 

self-selection of an appropriate 

medication or provide for followup 

monitoring during continued use. The 

conditions of use could include 

requiring pharmacist intervention to 

ensure appropriate nonprescription use. 

Additionally, conditions of safe use 

could involve the use of innovative 

technologies, such as diagnostics 

approved or cleared by FDA for use in 

the pharmacy or other setting. 

FDA is aware that industry is 

developing new technologies that 

consumers could use to self-screen for a 

particular disease or condition and 

determine whether a particular 

medication is appropriate for them. For 

example, kiosks or other technological 

aids in pharmacies or on the Internet 

could lead consumers through an 

algorithm for a particular drug product. 

Such an algorithm could consist of a 

series of questions that help consumers 

properly self-diagnose certain medical 

conditions, or determine whether 

specific medication warnings 

contraindicate their use of a drug 

product. In addition, for some drug 

products that require an initial 

prescription, the product could be made 

available as a nonprescription product 

with a condition of safe use for the 

purpose of product refills. 

In addition, some drug products that 

would otherwise require a prescription 

could be approved as nonprescription 

drug products with some type of 

pharmacist intervention as their 

condition of safe use. For example, 

some diseases or conditions might 

require confirmation of a diagnosis or 

routine monitoring using a diagnostic 

test (e.g., a blood test for cholesterol 

levels or liver function) that could be 

available in a pharmacy. A pharmacist, 

or consumer, could then use the results 

to determine whether use of a certain 

drug product is appropriate. Other 

potential roles for the pharmacist 

include assessing whether the consumer 

has any conditions or other risk factors 

that would indicate that the drug should 

not be used, or assisting the consumer 

in choosing between various drug 

products. For drugs that require use of 

a diagnostic test, creating a pathway for 

nonprescription use may result in the 

development by industry of diagnostics 

suitable for use by the patient or a 

pharmacy professional. 

FDA is also considering whether the 

same drug product could be 

simultaneously available as both a 

prescription and nonprescription 

product with conditions of safe use. 

Dual availability could help ensure 

greater access to needed medications by 

making obtaining them more flexible. 

Consumers could choose to continue 

seeing their health care practitioner to 

diagnose diseases or conditions and 

obtain prescriptions, and when their 

local retail establishment is not 

equipped to offer the nonprescription 

product with conditions of safe use. 

Other consumers could take advantage 

of the ability to obtain nonprescription 

products with conditions of safe use 

where they are available. 

FDA is seeking input on what types 

of evidence would be needed to 

demonstrate that certain drugs could be 

used safely and effectively in the 

nonprescription setting with conditions 

of safe use. We anticipate that, 

depending upon the situation, 

applications for approval of 

nonprescription products with 

conditions of safe use may need to 

include patient studies (e.g., selfselection studies, label comprehension 

studies, and actual use studies) to 

demonstrate that the drug would be safe 

and effective under the specified 

conditions. When a device, e.g., 

diagnostic test or computer algorithm, is 

necessary as a condition of safe use, 

evidence may need to be submitted 

demonstrating that it will perform its 

intended function and can be 

appropriately administered in the 

particular setting in which it will be 

used. We expect that certain classes of 

drugs may be appropriate candidates for 

nonprescription use under this new 

paradigm, but FDA would need to 

evaluate each NDA, and when 

applicable, each device, on a case-bycase basis. 

III. Scope of the Public Hearing 

FDA is holding this public hearing to 

seek input from interested members of 

the public including consumers, 

pharmacists, physicians and other 

members of the medical community, 

regulated industry, insurers, and 

managed care organizations on a 

potential new paradigm to allow certain 

drugs that would otherwise require a 

prescription to be approved as 

nonprescription drugs with conditions 

of safe use. FDA is interested in 

obtaining information and public 

comment on the following issues: 

A. Types of Technology and Conditions 

of Safe Use 

1. Can you suggest specific medical 

conditions or diseases for which 

consumers may benefit if the treatment 

drug were available as a nonprescription 

product with conditions of safe use? 

2. What types of technologies (e.g., 

kiosks, computer algorithms) are 

currently in development that could 

assist in allowing drugs to be used 

safely and effectively in the 

nonprescription setting? 


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3. What other types of conditions of 

safe use (e.g., pharmacy monitoring or 

counseling) could be used to help 

ensure the safe and effective use of 

certain drug products as 

nonprescription products? 

4. Are there types of diagnostic aids, 

such as noninvasive blood pressure 

monitors and urinalysis reagent strips, 

that could be used in the 

nonprescription setting after appropriate 

FDA review, either with or without the 

aid of a pharmacist to diagnose or 

monitor a disease or condition? 

5. What data or other information 

exist on the use of conditions of safe 

use, including novel technologies, and 

on their effects on health care, access to 

medication, and/or disease and 

treatment education or awareness? 

6. Are there data on how expanded 

access to medication or increased 

consumer education or awareness could 

affect patient or consumer behavior 

(e.g., by promoting patient compliance 

with a medication dosage regimen) or 

on health outcomes generally that 

would be relevant to the discussion of 

expanding the availability of 

nonprescription medications with 

conditions of safe use? 

7. What types of studies could be 

conducted to evaluate the effects of 

conditions of safe use on the safety and 

efficacy of particular drugs and on 

behavior and health outcomes? 

8. What types of studies could be 

conducted to evaluate the safety and 

efficacy of any technologies that might 

be relied upon as conditions of safe use? 

B. Pharmacy, Consumer, and Health 

Care Provider Issues 

1. Would this new paradigm increase 

consumer access to necessary medical 

care? 

2. Are data available about the 

number of consumers who require drug 

therapy for conditions or diseases but 

who currently do not take such 

medication because of the burdens 

associated with obtaining a 

prescription? 

3. Would a lack of oversight from a 

practitioner, including involvement in 

diagnosing the condition or monitoring 

for drug interactions or other drug 

effects, be a concern? If so, how could 

these concerns be addressed? 

4. How might the new paradigm be 

expected to affect consumers financially 

or otherwise affect access to and 

delivery of health care generally? 

5. Would expanding what could be 

considered nonprescription drugs under 

the new paradigm, and thus creating 

greater consumer access to needed drug 

products, reduce burden on emergency 

rooms and on individual health care 

providers, or otherwise increase the 

availability of these resources for other 

consumers? Are there other ways in 

which the new paradigm might reduce 

the burden on the health care system? 

6. How might various types of 

conditions of safe use on 

nonprescription drug products affect 

pharmacy business operations? What 

differences might there be in the 

operational issues experienced by 

pharmacies operated by chains and 

independently operated retail outlets? 

7. Would additional specialized 

training be needed for pharmacists if 

this paradigm were adopted? 

8. If availability of a nonprescription 

product with conditions of safe use 

were limited to certain outlets (e.g., a 

chain pharmacy that chooses to offer a 

particular technology or service), would 

the situation create confusion or 

difficulties for consumers seeking to 

obtain the drug product? Could such a 

situation create difficulties for 

practitioners in knowing whether a 

particular consumer could access the 

drug with a prescription or would be 

able to obtain the same product as a 

nonprescription drug product at a retail 

outlet? If so, how could these issues be 

overcome? 

9. What experiences have 

practitioners, pharmacists, and insurers 

had with state-authorized arrangements 

under which access to prescription 

drugs has been expanded that might be 

relevant to and inform our consideration 

of this paradigm (e.g., a collaborative 

practice agreement between a 

pharmacist and a practitioner that 

allows the pharmacist to dispense a 

prescription drug to a consumer who 

meets certain criteria under a standing 

or open prescription, when that 

consumer did not obtain a prescription 

directly from a practitioner, or that 

allows a pharmacist to refill a 

prescription after an initial prescription 

from a practitioner pursuant to a similar 

agreement)? 

10. What are the public health and 

regulatory implications of the use of in 

vitro diagnostic tests as conditions of 

safe use for nonprescription drug 

products in a pharmacy setting (e.g., as 

a laboratory under the Clinical 

Laboratory Improvement Act of 1988 

(CLIA) (Public Law 100–578))? 

C. Other Related Issues 

1. How would insurance coverage of 

pharmaceuticals be affected by 

approving nonprescription products 

with conditions of safe use for widely 

prescribed prescription drugs under this 

paradigm? 

2. How would out-of-pocket costs for 

the insured be affected by making 

prescription drugs available as 

nonprescription products with 

conditions of safe use? 

3. Would the new paradigm increase 

liability concerns for pharmacists and 

pharmacies? To what extent would 

these concerns raise the cost of the 

services provided? 

4. What proprietary, technological, 

economic, or competitive barriers might 

impede widespread implementation of 

this paradigm? To the extent such 

impediments exist, are there suggestions 

for mitigating or avoiding the 

impediments specific to this paradigm? 

5. Would overall health care costs 

decrease if this paradigm were 

instituted? 

IV. Attendance and/or Participation in 

the Public Hearing 

The public hearing is free and seating 

will be on a first-come, first-served 

basis. Attendees who do not wish to 

make an oral presentation do not need 

to register. 

If you wish to make an oral 

presentation during the hearing, you 

must register by submitting either an 

electronic or a written request by 5 p.m. 

on March 9, 2012, to Lee Lemley (see 

FOR FURTHER INFORMATION CONTACT). You 

must provide your name, title, business 

affiliation (if applicable), address, 

telephone and fax numbers, email 

address, and type of organization you 

represent (e.g., industry, consumer 

organization). You also should submit a 

brief summary of the presentation, 

including the discussion topic(s) that 

will be addressed and the approximate 

time requested for your presentation. 

We encourage individuals and 

organizations with common interests to 

consolidate or coordinate their 

presentations to allow adequate time for 

each request for presentation. Persons 

registered to make an oral presentation 

should check in before the hearing. 

Participants should submit a copy of 

each presentation to Lee Lemley (see 

FOR FURTHER INFORMATION CONTACT) no 

later than March 19, 2012. We will file 

the hearing schedule, indicating the 

order of presentation and the time 

allotted to each person, with the 

Division of Dockets Management (see 

ADDRESSES). Additional information 

will also be available on the Internet at 

http://www.fda.gov/Drugs/NewsEvents/ 

ucm289290.htm. 

We will mail, email, or telephone the 

schedule to each participant before the 

hearing. In anticipation of the hearing 

presentations moving ahead of 

schedule, participants are encouraged to 

arrive early to ensure their designated 

order of presentation. Participants who 


tkelley on DSK3SPTVN1PROD with NOTICES
12062 Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 

are not present when called risk 

forfeiting their scheduled time. 

If you need special accommodations 

due to a disability, contact Lee Lemley 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance. 

V. Notice of Hearing Under 21 CFR Part 

15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, who 

will be accompanied by FDA senior 

management from the Office of the 

Commissioner and the relevant centers. 

Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation (21 CFR 15.30(e)). Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10), subpart C) 

(§ 10.203(a)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). (See section VII of this 

document for more details.) To the 

extent that the conditions for the 

hearing as described in this document 

conflict with any provisions set out in 

part 15, this document acts as a waiver 

of those provisions as specified in 

§ 15.30(h)). 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments for consideration. Persons 

who wish to provide additional 

materials for consideration should file 

these materials with the Division of 

Dockets Management. You should 

annotate and organize your comments to 

identify the specific questions identified 

by the topic to which they refer. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VII. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript also will 

be available in either hard copy or on 

CD–ROM after submission of a Freedom 

of Information request. Written requests 

are to be sent to the Division of Freedom 

of Information (ELEM–1029), Office of 

Management Programs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4597 Filed 2–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Cardiovascular and Renal Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Cardiovascular 

and Renal Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 27, 2012, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

Building 31 Conference Center, the 

Great Room (rm. 1503), 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Kristina Toliver, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: CRDAC@fda.hhs.

gov, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), and follow the prompts to the 

desired center or product area. Please 

call the Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On March 27, 2012, the 

committee will begin with a closed 

session from 8 a.m. to 10:45 a.m. 

Following the closed session, from 11 

a.m. to 5 p.m., the meeting will be open 

to the public. The committee will 

discuss biologics license application 

125410, proposed tradename 

REPLAGAL (agalsidase alfa), submitted 

by Shire Human Genetics Therapies, for 

an enzyme replacement therapy for 

patients with Fabry disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: On March 27, 2012, from 

11 a.m. to 5 p.m., the meeting is open 

to the public. Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 13, 2012. 

Oral presentations from the public will 

be scheduled between approximately 

2:10 p.m. and 3:10 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 5, 2012. Time allotted 


tkelley on DSK3SPTVN1PROD with NOTICES