Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13513 

1See Enhanced Prudential Standards and Early 

Remediation Requirements for Covered Companies, 

77 FR 594 (Jan. 5, 2012). 

2 Id. 

3 Id. 

4See, e.g., Comment letters to the Board from The 

Clearing House et al. (Jan. 25, 2012); and The 

Geneva Association (Feb. 13, 2013). 

http://www.fsis.usda.gov/ 

News_&_Events/Email_Subscription/. 

Options range from recalls to export 

information to regulations, directives, 

and notices. Customers can add or 

delete subscriptions themselves, and 

have the option to password protect 

their accounts. 

USDA Nondiscrimination Statement 

USDA prohibits discrimination in all 

its programs and activities on the basis 

of race, color, national origin, gender, 

religion, age, disability, political beliefs, 

sexual orientation, and marital or family 

status (Not all prohibited bases apply to 

all programs). 

Persons with disabilities who require 

alternative means for communication of 

program information (Braille, large 

print, and audiotape) should contact 

USDA’s Target Center at (202) 720–2600 

(voice and TTY). 

To file a written complaint of 

discrimination, write USDA, Office of 

the Assistant Secretary for Civil Rights, 

1400 Independence Avenue SW., 

Washington, DC 20250–9410 or call 

(202) 720–5964 (voice and TTY). USDA 

is an equal opportunity provider and 

employer. 

Done at Washington, DC, on March 5, 

2012. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. 2012–5656 Filed 3–5–12; 4:15 pm] 

BILLING CODE 3410–DM–P 

FEDERAL RESERVE SYSTEM 

12 CFR Part 252 

[Regulation YY; Docket No. 1438] 

RIN 7100–AD–86 

Enhanced Prudential Standards and 

Early Remediation Requirements for 

Covered Companies 

AGENCY: Board of Governors of the 

Federal Reserve System (Board). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: On January 5, 2012, the Board 

published in the Federal Register a 

notice of proposed rulemaking for 

public comment to implement the 

enhanced prudential standards required 

to be established under section 165 of 

the Dodd-Frank Wall Street Reform and 

Consumer Protection Act (Dodd-Frank 

Act or Act) and the early remediation 

requirements established under section 

166 of the Act. 

Due to the range and complexity of 

the issues addressed in the rulemaking, 

the Board has determined that an 

extension of the end of the public 

comment period from March 31, 2012, 

until April 30, 2012, is appropriate. This 

action will allow interested persons 

additional time to analyze the proposed 

rules and prepare their comments. 

DATES: Comments on the proposed rule 

must be received on or before April 30, 

2012. 

ADDRESSES: You may submit comments 

by any of the methods identified in the 

proposed rule.1 Please submit your 

comments using only one method. 

FOR FURTHER INFORMATION CONTACT: 

Molly E. Mahar, Senior Supervisory 

Financial Analyst, (202) 973–7360, 

Division of Banking Supervision and 

Regulation; or Laurie Schaffer, Associate 

General Counsel, (202) 452–2272, or 

Dominic A. Labitzky, Senior Attorney, 

(202) 452–3428, Legal Division. 

SUPPLEMENTARY INFORMATION: The 

proposed rule was published in the 

Federal Register on January 5, 2012,2

and would implement the enhanced 

prudential standards required to be 

established under section 165 of the 

Dodd-Frank Act and the early 

remediation requirements established 

under section 166 of the Act. The 

enhanced standards include risk-based 

capital and leverage requirements, 

liquidity standards, requirements for 

overall risk management (including 

establishing a risk committee), singlecounterparty credit limits, stress test 

requirements, and a debt-to-equity limit 

for companies that the Financial 

Stability Oversight Council has 

determined pose a grave threat to 

financial stability. 

In recognition of the complexities of 

the issues addressed and the variety of 

considerations involved with 

implementation of the proposal, the 

Board requested that commenters 

respond to numerous questions. The 

proposed rule stated that the public 

comment period would close on March 

31, 2012.3

The Board has received requests from 

the public for an extension of the 

comment period to allow for additional 

time for comments related to the 

provisions of the proposed rule.4 The 

Board believes that the additional 

period for comment will facilitate 

public comment on the provisions of the 

proposed rule and the questions posed 

by the Board. Therefore, the Board is 

extending the comment period for the 

proposed rule from March 31, 2012 to 

April 30, 2012. 

By order of the Board of Governors of the 

Federal Reserve System, acting through the 

Secretary under delegated authority, March 

2, 2012. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. 2012–5522 Filed 3–6–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2012–N–0170] 

Modernizing the Regulation of Clinical 

Trials and Approaches to Good 

Clinical Practice; Public Hearing; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public hearing to obtain input 

from interested persons on FDA’s scope 

and direction in modernizing the 

regulations, policies, and practices that 

apply to the conduct of clinical trials of 

FDA-regulated products. Clinical trials 

are a critical source of evidence to 

inform medical policy and practice, and 

effective regulatory oversight is needed 

to ensure that human subjects are 

protected and resulting clinical trial 

data are credible and accurate. FDA is 

aware of concerns within the clinical 

trial community that certain regulations 

and policies applicable to the conduct 

of clinical trials may result in 

inefficiencies or increased cost and may 

not facilitate the use of innovative 

methods and technological advances to 

improve clinical trial quality. The 

Agency is involved in an effort to 

modernize the regulatory framework 

that governs clinical trials and 

approaches to good clinical practice 

(GCP). The purpose of this hearing is to 

solicit public input from a broad group 

of stakeholders on the scope and 

direction of this effort, including 

encouraging the use of innovative 

models that may enhance the 

effectiveness and efficiency of the 

clinical trial enterprise. 

DATES: Date and Time: The public 

hearing will be held on April 23 and 24, 

2012, from 8:30 a.m. to 4:30 p.m. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
13514 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

1For more information on FDA’s Critical Path 

Initiative, see http://www.fda.gov/ScienceResearch/ 

SpecialTopics/CriticalPathInitiative/default.htm. 

2For more information on FDA’s Human Subject 

Protection and Bioresearch Monitoring Initiative, 

see http://www.fda.gov/ScienceResearch/

SpecialTopics/RunningClinicalTrials/ucm226306.

htm. 

3For more information on the Clinical Trials 

Transformation Initiative, see https://www.

trialstransformation.org/. 

4 76 FR 23520; April 27, 2011. 

5 76 FR 3821. 

Individuals who wish to attend or 

present at the public hearing must 

register on or before close of business on 

April 2, 2012. To register for the public 

hearing, email your registration 

information to ClinTrialPublicMt@fda.

hhs.gov. Section IV of this document 

provides attendance and registration 

information. Electronic or written 

comments will be accepted after the 

public hearing until May 31, 2012. 

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. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Identify comments with the 

corresponding docket number found in 

brackets in the heading of this 

document. 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the public 

hearing (see section VII of this 

document). 

A live webcast of this public hearing 

can be viewed at the following Web 

address on the days of the public 

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

NewsEvents/ucm284118.htm. A video 

record of the public hearing will be 

available at the same Web address for 1 

year. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Hymiller, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6333, 

Silver Spring, MD 20993–0002, 301– 

796–2147, FAX: 301–847–3529, Email: 

ClinTrialPublicMt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Clinical trials that yield reliable data 

are critical to FDA’s mission to ensure 

that drugs, biologics, and medical 

devices are safe and effective. The 

regulations that govern the conduct of 

clinical trials and the protection of 

human subjects have been in existence 

for more than 25 years. In the 

intervening years, there have been 

dramatic changes in the clinical trial 

enterprise, including increased size and 

complexity of clinical trials, increases in 

the number of clinical trials performed 

globally, greater use of contract research 

organizations (CROs), participation of 

vulnerable populations, and numerous 

scientific and technological advances. 

Given these changes and the evolution 

of the clinical trial enterprise, FDA is 

evaluating its regulatory approach to 

clinical trial oversight to ensure that it 

meets the regulatory objectives of 

ensuring human subject protection and 

the quality and integrity of data 

supporting regulatory decision-making, 

without being unnecessarily 

burdensome or unduly impeding 

implementation of innovative 

approaches. FDA has already taken a 

number of steps to improve and 

modernize its regulations, policies, and 

practices to ensure they provide for 

optimal clinical trial quality, data 

integrity, human subject protection, and 

flexibility. 

In 2004, FDA introduced the Critical 

Path Initiative (CPI),1 intended to 

transform the way medical products are 

developed, evaluated, and 

manufactured. One of the CPI’s key 

areas of focus is modernizing clinical 

trial sciences to make trials safer and 

more efficient. As part of this larger 

initiative, FDA launched two initiatives 

to specifically address human subject 

protection, data integrity, and clinical 

trial quality and efficiency. 

In 2006, FDA launched the Human 

Subject Protection and Bioresearch 

Monitoring Initiative 2 aimed at 

modernizing and strengthening FDA’s 

oversight and protection of human 

subjects and the integrity of data in 

clinical trials. FDA’s Office of Good 

Clinical Practice in the Office of the 

Commissioner is leading this effort. 

FDA also established a Human Subject 

Protection and Bioresearch Monitoring 

Council that manages and sets FDA 

policy on bioresearch monitoring, GCP, 

and human subject protection. 

In 2007, FDA and Duke University 

formed the Clinical Trials 

Transformation Initiative (CTTI),3 a 

public-private partnership with the goal 

of improving the quality and efficiency 

of clinical trials. CTTI has been 

involved in a range of projects, 

including projects to identify best 

practices for monitoring and designing 

quality into clinical trials, improve 

serious adverse event reporting to 

investigators, and gather best practices 

for premarket safety surveillance. 

In 2011, FDA published a Federal 

Register notice requesting comment on 

the development of a plan for the 

retrospective review of existing FDA 

regulations 4 in accordance with 

Executive Order 13563, ‘‘Improving 

Regulation and Regulatory Review.’’ As 

part of this plan, FDA is conducting a 

review of existing regulations to 

determine which, if any, of its rules are 

outmoded, ineffective, insufficient or 

excessively burdensome and may be 

good candidates to be modified, 

streamlined, expanded or repealed. The 

Agency is also evaluating its framework 

for periodically analyzing existing 

rules.5

Over the past few years, FDA has 

issued a number of regulations and 

guidance documents related to clinical 

trial conduct. The following regulations 

and guidances are highlighted below to 

exemplify the direction and scope of 

FDA’s effort to modernize the 

regulations, policies, and practices that 

apply to the conduct of clinical trials. 

The CPI, Human Subject Protection and 

Bioresearch Monitoring Initiative, and 

CTTI have helped inform these 

regulations and guidances: 

1. Investigational New Drug Safety 

Reporting Requirements for Human 

Drug and Biological Products and Safety 

Reporting Requirements for 

Bioavailability and Bioequivalence 

Studies—Final Rule, published 

September 29, 2010 (75 FR 59935); 

2. Investigator Responsibilities— 

Protecting the Rights, Safety, and 

Welfare of Study Subjects—Final 

Guidance, published October 26, 2009 

(74 FR 55052); 

3. Oversight of Clinical Investigations: 

A Risk-Based Approach to Monitoring— 

Draft Guidance, published August 29, 

2011 (76 FR 53683); 

4. Electronic Source Documentation 

in Clinical Investigations—Draft 

Guidance, published January 7, 2011 (76 

FR 1173); 

5. Adverse Event Reporting to IRBs— 

Improving Human Subject Protection— 

Final Guidance, published January 15, 

2009 (74 FR 2599); 

6. Exception from Informed Consent 

Requirements for Emergency Research— 

Final Guidance, published April 4, 2011 

(76 FR 18558); 

The collaborative effort with CTTI 

also identified Quality Risk 

Management (QRM) principles and 

Quality by Design (QbD) as models that, 

with adaptations, could contribute to 

improved data quality and integrity in 

clinical trials. QRM is a systematic 

process to identify, assess, control, 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13515 

6For more information on the EMA–FDA Good 

Clinical Practice Initiative, see http://www.fda.gov/ 

downloads/InternationalPrograms/

FDABeyondOurBordersForeignOffices/

EuropeanUnion/EuropeanUnion/

EuropeanCommission/UCM266259.pdf. 

communicate, and review the risks 

associated with a process or activity. 

QbD, a risk-based, quality approach that 

has been successful in the 

manufacturing arena, emphasizes 

building quality into a process from the 

beginning. Applied to clinical trials, this 

approach would prospectively define 

factors most critical to trial quality and 

data integrity (e.g., proper 

randomization, effective blinding to 

ensure unbiased ascertainment and 

analysis of study outcomes) and 

prospectively identify risks critical to 

those factors. The sponsor would then 

design the protocol, oversight and 

monitoring mechanisms, as well as data 

management, archiving, and analysis 

processes to eliminate or mitigate those 

risks. 

FDA has also taken steps to improve 

its clinical trial inspection processes 

and coordinate inspection processes 

globally. Ongoing efforts are aimed at 

developing new approaches for 

selecting clinical investigator sites for 

inspection and for improving the 

warning letter process. FDA is also 

involved in a Good Clinical Practice 

Initiative 6 with the European Medicines 

Agency (EMA), in which FDA and the 

EMA have shared information on 

applications, collaborated on joint and 

observational inspections, participated 

in bilateral training, and kept each other 

informed of GCP-related legislation, 

regulatory guidance, and related 

documents. These steps have facilitated 

improvements in FDA’s inspection 

coverage and decision-making 

processes. 

In various forums, FDA has been told 

that certain regulations and compliance 

practices may result in inefficiencies or 

may not facilitate the use of innovative 

methods to improve clinical trial quality 

or the use of technological advances 

(e.g., use of the Internet to gather data, 

conduct certain types of research, obtain 

informed consent). FDA has also heard 

from clinical trial sponsors and CROs 

that sponsors and CROs are reluctant to 

change their processes related to clinical 

trial oversight and management because 

of uncertainty about whether new 

processes would be in compliance with 

applicable regulations. FDA recognizes 

that it must effectively leverage its 

available resources and take additional 

steps to strategically evolve and 

modernize its regulatory approach to the 

conduct of clinical trials. FDA is 

striving to align regulatory processes to 

meet the needs of its many stakeholders, 

including those who design and 

conduct trials, those who participate in 

trials, and those who depend on the 

results of those trials to make informed 

health care decisions. 

II. Purpose of Hearing 

The purpose of this public hearing is 

to obtain input from clinical trial 

sponsors, CROs, clinical investigators, 

academic institutions, institutional 

review boards (IRBs), professional 

societies, trade organizations, patient 

and consumer groups, and other 

interested parties on the scope and 

direction of FDA’s future efforts to 

evolve and modernize its regulatory 

approach to the conduct and oversight 

of clinical trials. FDA’s primary focus is 

on good clinical practice, including 

clinical protocol design to ensure the 

reliability of data, safety surveillance 

and reporting, quality control processes 

(e.g., monitoring and training), quality 

assurance (e.g., auditing), and any other 

processes directed at ensuring trial 

quality, data integrity, or human subject 

protection. FDA is interested in ways 

(e.g., workshops, strategic alliances) to 

foster implementation of innovative 

methods to ensure human subject 

protection and data quality and 

integrity, including risk-based 

approaches in the design, oversight, and 

conduct of clinical investigations. FDA 

is seeking feedback on specific GCP 

regulations, policies, and practices that 

may need clarification or revision to 

facilitate advances in the ways that 

clinical trials are conducted, remove 

impediments to the use of innovative 

approaches, or otherwise improve the 

conduct of clinical trials. FDA also 

welcomes comments on additional 

issues that will help the Agency 

modernize its oversight and improve the 

quality and efficiency of clinical trials. 

III. Issues for Discussion 

In addition to the general information 

requests in section II of this document, 

FDA is interested in obtaining 

information and public comment on the 

following specific issues. 

1. Increasing clinical trial complexity 

(e.g., participation of vulnerable 

populations, increased frequency of 

outsourcing) and globalization are 

posing challenges for sponsors, clinical 

investigators, IRBs, patients, and FDA. 

FDA has been involved in a number of 

efforts to ensure that the Agency’s GCP 

regulations, policies, and practices are 

optimal for ensuring clinical trial 

quality, data integrity, and human 

subject protection while providing 

flexibility to conduct trials in the 21st 

century. 

a. What additional efforts should FDA 

pursue to modernize the Agency’s GCP 

regulations, policies, and practices? For 

example, are there specific FDA 

regulations, guidances, or practices (e.g., 

compliance programs) that should be a 

high priority for clarification or 

revision? Are there other steps (e.g., 

pilot projects, strategic alliances) that 

would help ensure clinical trial quality 

and subject safety, provide flexibility, or 

improve the efficiency of the clinical 

trial process? For each of the suggested 

efforts, specifically identify the reasons 

that the current approach is not optimal, 

how the suggested effort would ensure 

clinical trial quality, subject safety, and/ 

or improve the efficiency of the clinical 

trial process, and what the preferred 

priority of the efforts should be. 

b. What efforts could FDA consider 

that could help mitigate some of the 

challenges resulting from increased 

clinical trial complexity and 

globalization? For each of the suggested 

efforts, specifically identify how the 

effort could help mitigate these 

challenges. 

2. FDA is interested in fostering the 

use of innovative methods and models, 

including QRM principles and QbD, as 

well as the use of technological 

advances (e.g., use of the Internet to 

gather data, conduct certain types of 

research, obtain informed consent). The 

Agency seeks comments on how the use 

of innovative methods, models, and 

technological advances could contribute 

to data integrity, clinical trial quality, 

and the safety of human subjects, as 

well as streamline the conduct of 

clinical trials. 

a. What are some innovative methods 

or models that facilitate building quality 

into the conduct of trials (e.g., by 

identifying, preventing, or minimizing 

errors that have the potential to 

compromise human subject safety and 

data integrity)? FDA requests feedback 

on experiences with implementing such 

methods or models (e.g., lessons 

learned), as well as data supporting the 

use of any suggested methods or 

models. 

b. FDA recognizes that the clinical 

trial process involves various 

stakeholders (e.g., sponsors, CROs, IRBs, 

investigators, patients) with different 

roles and responsibilities in ensuring 

human subject protection and 

generating valid study data. What are 

the specific stakeholder challenges 

presented by FDA’s GCP regulations, 

policies, and/or practices to building 

quality into the clinical trial process 

(e.g., for a study that is conducted and 

overseen by multiple entities)? 

c. What are some ways in which FDA 

could encourage adoption of these 


tkelley on DSK3SPTVN1PROD with PROPOSALS
13516 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

methods and models? For example, how 

can FDA support effective 

communication and coordination 

among all entities involved in the 

conduct of a trial to ensure a focus on 

the protection of human subjects and 

quality across the clinical trial process? 

d. How should FDA focus its efforts 

in GCP regulations, policies, or practices 

to facilitate the use of technological 

advances, while maintaining the 

protection of research participants and 

the quality and integrity of data 

supporting regulatory decision-making? 

IV. Attendance and Registration 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures and limited 

seating. Attendance is free and will be 

on a first-come, first-serve basis. 

Individuals who wish to attend the 

public hearing must register by sending 

an email to ClinTrialPublicMt@fda.hhs.

gov on or before April 2, 2012, and 

provide complete contact information, 

including: Name, title, affiliation, 

address, email, and phone number. 

Those without email access may register 

by contacting Jennifer Hymiller (see FOR

FURTHER INFORMATION CONTACT). Because 

seating is limited, FDA may limit the 

numbers of participants from each 

organization. Registrants will receive 

confirmation once they have been 

accepted for participation in the 

hearing. Onsite registration on the day 

of the hearing will be based on space 

availability on the day of the event 

starting at 7:30 a.m. If registration 

reaches maximum capacity, FDA will 

post a notice closing the meeting 

registration for the hearing at http://

www.fda.gov/Drugs/NewsEvents/

ucm284118.htm. 

Individuals who wish to present at 

the public hearing must register on or 

before April 2, 2012, through the email 

ClinTrialPublicMt@fda.hhs.gov, and 

state this intention on their notice of 

participation. You must provide 

complete contact information, 

including: Name, title, affiliation, 

address, email, and phone number. FDA 

has included questions for comment in 

section III of this document. You should 

identify the topic or section and the 

number of each question you wish to 

address in your presentation, so that 

FDA can consider that in organizing the 

presentations. Individuals and 

organizations with common interests 

should consolidate or coordinate their 

presentations and request time for a 

joint presentation. FDA will do its best 

to accommodate requests to speak and 

will determine the amount of time 

allotted for each oral presentation, and 

the approximate time that each oral 

presentation is scheduled to begin. FDA 

will notify registered presenters of their 

scheduled times, and make available a 

draft agenda on http://www.fda.gov/

Drugs/NewsEvents/ucm284118.htm 

approximately 2 weeks before the public 

hearing. Once FDA notifies registered 

presenters of their scheduled times, 

presenters should submit to electronic 

copy of their presentation to 

ClinTrialPublicMt@fda.hhs.gov on or 

before April 16, 2012. 

If you need special accommodations 

because of disability, please contact 

Jennifer Hymiller (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

A live webcast of this public hearing 

can be viewed at the following Web 

address on the days of the public 

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

NewsEvents/ucm284118.htm. A video 

record of the public hearing will be 

available at the same Web address for 

1 year. 

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, the Center for Drug 

Evaluation and Research, the Center for 

Biologics Evaluation and Research, and 

the Center for Devices and Radiological 

Health. 

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. 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, subpart C (21 CFR 

part 10, subpart C)). 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). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

VI. Request for Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

either electronic or written comments to 

the Division of Dockets Management 

(see ADDRESSES). 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 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management (see ADDRESSES) 

and on the Internet at http://www.

regulations.gov approximately 30 days 

after the public hearing. A transcript 

will also be made available in either 

hard copy or on CD–ROM, upon 

submission of a Freedom of Information 

request. Written requests are to be sent 

to the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. 

Dated: March 1, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5476 Filed 3–6–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2012–0043] 

RIN 1625—AA00 

Safety Zone; Antique Boat Show, 

Niagara River, Grand Island, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish a temporary safety zone on 

Niagara River, Grand Island, NY. This 

proposed rule is intended to restrict 

vessels from a portion of the Niagara 

River during the Antique Boat Show 

powerboat races. The safety zone 

established by this proposed rule is 

necessary to protect spectators, 

participants, and vessels from the 

hazards associated with powerboat 

races. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before April 6, 2012. 


tkelley on DSK3SPTVN1PROD with PROPOSALS