15762 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

compensation program. Key functions of 

the ABRWH include providing advice 

on the development of probability of 

causation guidelines that have been 

promulgated by the Department of 

Health and Human Services (HHS) as a 

final rule; advice on methods of dose 

reconstruction which have also been 

promulgated by HHS as a final rule; 

advice on the scientific validity and 

quality of dose estimation and 

reconstruction efforts being performed 

for purposes of the compensation 

program; and advice on petitions to add 

classes of workers to the Special 

Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the ABRWH to 

HHS, which subsequently delegated this 

authority to CDC. NIOSH implements 

this responsibility for CDC. The charter 

was issued on August 3, 2001, renewed 

at appropriate intervals, and will expire 

on August 3, 2013. 

Purpose: The ABRWH is charged with 

(a) providing advice to the Secretary, 

HHS, on the development of guidelines 

under Executive Order 13179; (b) 

providing advice to the Secretary, HHS, 

on the scientific validity and quality of 

dose reconstruction efforts performed 

for this program; and (c) upon request 

by the Secretary, HHS, advising the 

Secretary on whether there is a class of 

employees at any Department of Energy 

facility who were exposed to radiation 

but for whom it is not feasible to 

estimate their radiation dose, and on 

whether there is a reasonable likelihood 

that such radiation doses may have 

endangered the health of members of 

this class. The Subcommittee on 

Procedures Review was established to 

aid the ABRWH in carrying out its duty 

to advise the Secretary, HHS, on dose 

reconstructions. The Subcommittee on 

Procedures Review is responsible for 

overseeing, tracking, and participating 

in the reviews of all procedures used in 

the dose reconstruction process by the 

NIOSH Division of Compensation 

Analysis and Support (DCAS) and its 

dose reconstruction contractor. 

Matters to be Discussed: The agenda 

for the Subcommittee meeting includes 

discussion of the following Oak Ridge 

Associated Universities (ORAU) and 

Division of Compensation Analysis and 

Support (DCAS) procedures: Office of 

Compensation Analysis and Support 

(OCAS) TIB–0010 ‘‘Best Estimate 

External Dose Reconstruction for 

Glovebox Workers’’); DCAS TIB–0013 

(‘‘Selected Geometric Exposure Scenario 

Considerations for External Dose 

Reconstruction at Uranium Facilities’’), 

OTIB–0052 (‘‘Parameters to Consider 

When Processing Claims for 

Construction Trade Workers’’), OTIB– 

0054 (‘‘Fission and Activation Product 

Assignment for Internal Dose-Related 

Gross Beta and Gross Gamma 

Analyses’’), and PER 20 (‘‘Blockson TBD 

Revision’’); Identification of 

Overarching Dose Reconstruction 

Issues; Discussion of Completed 

Procedure Reviews for Summarization; 

and a continuation of the commentresolution process for other dose 

reconstruction procedures under review 

by the Subcommittee. 

The agenda is subject to change as 

priorities dictate. 

In the event an individual cannot 

attend, written comments may be 

submitted. Any written comments 

received will be provided at the meeting 

and should be submitted to the contact 

person below well in advance of the 

meeting. 

Contact Person for More Information: 

Theodore Katz, Executive Secretary, 

NIOSH, CDC, 1600 Clifton Road NE., 

Mailstop E–20, Atlanta, Georgia 30333, 

Telephone (513) 533–6800, Toll Free 1 

(800) CDC–INFO, Email dcas@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 9, 2012. 

John Kastenbauer, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2012–6475 Filed 3–15–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0627] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; General 

Administrative Procedures: Citizen 

Petitions; Petition for Reconsideration 

or Stay of Action; Advisory Opinions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 16, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0183. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

General Administrative Procedures: 

Citizen Petitions; Petition for 

Reconsideration or Stay of Action; 

Advisory Opinions—(OMB Control 

Number 0910–0183)—Extension 

The Administrative Procedures Act (5 

U.S.C. 553(e)), provides that every 

Agency shall give an interested person 

the right to petition for issuance, 

amendment, or repeal of a rule. Section 

10.30 (21 CFR 10.30) sets forth the 

format and procedures by which an 

interested person may submit to FDA, in 

accordance with § 10.20 (21 CFR 10.20) 

(submission of documents to Division of 

Dockets Management), a citizen petition 

requesting the Commissioner of FDA 

(the Commissioner) to issue, amend, or 

revoke a regulation or order, or to take 

or refrain from taking any other form of 

administrative action. 

The Commissioner may grant or deny 

such a petition, in whole or in part, and 

may grant such other relief or take other 

action as the petition warrants. 

Respondents are individuals or 

households, State or local governments, 

not-for-profit institutions or groups. 

Section 10.33 (21 CFR 10.33) issued 

under section 701(a) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 371(a)), sets forth 

the format and procedures by which an 

interested person may request 

reconsideration of part or all of a 

decision of the Commissioner on a 

petition submitted under 21 CFR 10.25 

(initiation of administrative 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15763 

proceedings). A petition for 

reconsideration must contain a full 

statement in a well-organized format of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision involved. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals of 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting from the 

Commissioner a reconsideration of a 

matter. 

Section 10.35 (21 CFR 10.35), issued 

under section 701(a) of the FD&C Act, 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20, the 

Commissioner to stay the effective date 

of any administrative action. 

Such a petition must do the following: 

(1) Identify the decision involved; (2) 

state the action requested, including the 

length of time for which a stay is 

requested; and (3) include a statement of 

the factual and legal grounds on which 

the interested person relies in seeking 

the stay. FDA uses the information 

provided in the request to determine 

whether to grant the petition for stay of 

action. 

Respondents to this information 

collection are interested persons who 

choose to file a petition for an 

administrative stay of action. 

Section 10.85 (21 CFR 10.85), issued 

under section 701(a) of the FD&C Act 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20, an advisory 

opinion from the Commissioner on a 

matter of general applicability. An 

advisory opinion represents the formal 

position of FDA on a matter of general 

applicability. When making a request, 

the petitioner must provide a concise 

statement of the issues and questions on 

which an opinion is requested, and a 

full statement of the facts and legal 

points relevant to the request. 

Respondents to this collection of 

information are interested persons 

seeking an advisory opinion from the 

Commissioner on the Agency’s formal 

position for matters of general 

applicability. 

In accordance with 5 CFR 1320.8(d), 

FDA published a 60-day notice for 

public comment in the Federal Register 

of September 7, 2011 (76 FR 55396), to 

which the Agency received one 

comment. However, this comment did 

not address the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.30 .................................................................................... 207 1 207 24 4,968 

10.33 .................................................................................... 4 1 4 10 40 

10.35 .................................................................................... 5 1 5 10 50 

10.85 .................................................................................... 4 1 4 16 64 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,122 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. In 2010, FDA received 

approximately 207 petitions (§ 10.30), 4 

administrative reconsiderations of 

action (§ 10.33), 5 administrative stays 

of action (§ 10.35), and 4 advisory 

opinions (§ 10.85). 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6392 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0625] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 16, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0184. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES