24752 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting of the 

aforementioned committee: 

Times and Dates: 

8:00 a.m.–5:00 p.m., June 13, 2013 (Closed) 

8:00 a.m.–5:00 p.m., June 14, 2013 (Closed) 

Place: Embassy Suites, 1900 Diagonal 

Road, Alexandria, Virginia 22314, 

Telephone: (703) 684–5900, Fax: (703) 684– 

0653. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Purpose: The Safety and Occupational 

Health Study Section will review, discuss, 

and evaluate grant application(s) received in 

response to the Institute’s standard grants 

review and funding cycles pertaining to 

research issues in occupational safety and 

health, and allied areas. 

It is the intent of NIOSH to support broadbased research endeavors in keeping with the 

Institute’s program goals. This will lead to 

improved understanding and appreciation for 

the magnitude of the aggregate health burden 

associated with occupational injuries and 

illnesses, as well as to support more focused 

research projects, which will lead to 

improvements in the delivery of occupational 

safety and health services, and the 

prevention of work-related injury and illness. 

It is anticipated that research funded will 

promote these program goals. 

Matters To Be Discussed: The meeting will 

convene to address matters related to the 

conduct of Study Section business and for 

the study section to consider safety and 

occupational health-related grant 

applications. These portions of the meeting 

will be closed to the public in accordance 

with provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and the 

Determination of the Director, Management 

Analysis and Services Office, Centers for 

Disease Control and Prevention, pursuant to 

Section 10(d) Public Law 92–463. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Price 

Connor, Ph.D., NIOSH Health Scientist, CDC, 

2400 Executive Parkway, Mailstop E–20, 

Atlanta, Georgia 30345, Telephone: (404) 

498–2511, Fax: (404) 498–2571. 

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. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–09873 Filed 4–25–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Subcommittee for Dose 

Reconstruction Reviews (SDRR), 

Advisory Board on Radiation and 

Worker Health (ABRWH or the 

Advisory Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting for the 

aforementioned subcommittee: 

Time and Date: 9:00 a.m.–5:00 p.m. 

Eastern Time, May 21, 2013. 

Place: Cincinnati Airport Marriott, 2395 

Progress Drive, Hebron, Kentucky 41018, 

Telephone (859) 334–4611, Fax (859) 334– 

4619. 

Status: Open to the public, but without a 

public comment period. To access by 

conference call dial the following 

information 1 (866) 659–0537, Participant 

Pass Code 9933701. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

Act of 2000 to advise the President on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board 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 Advisory Board 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 Advisory Board 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, advise 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 reasonable likelihood 

that such radiation doses may have 

endangered the health of members of this 

class. The Subcommittee for Dose 

Reconstruction Reviews was established to 

aid the Advisory Board in carrying out its 

duty to advise the Secretary, HHS, on dose 

reconstruction. 

Matters to be Discussed: The agenda for the 

Subcommittee meeting includes: dose 

reconstruction program quality management 

and assurance activities, including: current 

findings from NIOSH internal dose 

reconstruction blind reviews; and discussion 

of dose reconstruction cases under review 

(sets 8–9, and Savannah River Site, Rocky 

Flats Plant, and Los Alamos National 

Laboratory cases from sets 10–13). 

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 M. Katz, M.P.A., Designated 

Federal Officer, NIOSH, CDC, 1600 Clifton 

Road, NE., Mailstop E–20, Atlanta, Georgia 

30333, Telephone (513) 533–6800, Toll Free 

1–800–CDC–INFO, Email ocas@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. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–09877 Filed 4–25–13; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–685, CMS– 

10436, CMS–10452, CMS–10180 and CMS– 

R–199] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 


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Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 24753 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a previously 

approved collection; Title of 

Information Collection: End Stage Renal 

Disease (ESRD) Network Semi-Annual 

Cost Report Forms and Supporting 

Regulations in 42 CFR section 405.2110 

and 42 CFR 405.2112; Use: Section 

1881(c) of the Social Security Act 

establishes End Stage Renal Disease 

(ESRD) Network contracts. The 

regulations found at 42 CFR 405.2110 

and 405.2112 designated 18 ESRD 

Networks which are funded by 

renewable contracts. These contracts are 

on 3-year cycles. To better administer 

the program, CMS is requiring 

contractors to submit semi-annual cost 

reports. The purpose of the cost reports 

is to enable the ESRD Networks to 

report costs in a standardized manner. 

This will allow CMS to review, compare 

and project ESRD Network costs during 

the life of the contract. Since the last 

collection, the survey instrument has 

been revised. The burden has not 

changed. Form Number: CMS–685 

(OMB#: 0938–0657); Frequency: 

Reporting—Semi-annually; Affected 

Public: Not-for-profit institutions; 

Number of Respondents: 18; Total 

Annual Responses: 36; Total Annual 

Hours: 108. (For policy questions 

regarding this collection contact 

Benjamin Bernstein at 410–786–6570. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Evaluation of 

the Multi-Payer Advanced Primary Care 

Practice Demonstration; Use: On 

September 16, 2009, the Department of 

Health and Human Services announced 

the establishment of the Multi-Payer 

Advanced Primary Care Practice 

(MAPCP) Demonstration, under which 

Medicare joined Medicaid and private 

insurers as a payer participant in statesponsored initiatives to promote the 

principles that characterize advanced 

primary care, often referred to as the 

‘‘patient-centered medical home’’ 

(PCMH). The CMS selected eight states 

to participate in this demonstration: 

Maine, Vermont, Rhode Island, New 

York, Pennsylvania, North Carolina, 

Michigan, and Minnesota. These states 

vary on a number of important 

dimensions, such as features of their 

public (Medicaid) and private insurance 

markets, delivery system, prior 

experience with medical home 

initiatives, and nature of their statesponsored multi-payer initiative. 

CMS is conducting an evaluation of 

the demonstration to assess the effects 

of advanced primary care practice when 

supported by Medicare, Medicaid, and 

private health plans. As part of this 

evaluation, qualitative and quantitative 

data will be collected and analyzed to 

answer research questions focused on: 

(1) State initiative features and 

implementation, including various 

payment models; (2) practice 

characteristics, particularly medical 

home transformation; and (3) outcomes, 

including access to and coordination of 

care, clinical quality of care and patient 

safety, beneficiary experience with care, 

patterns of utilization, Medicare and 

Medicaid expenditures, and budget 

neutrality. 

Subsequent to the publication of the 

60-day Federal Register notice (May 31, 

2012; 77 FR 32118), the interview 

protocols have been revised by adding, 

revising and/or deleting questions. Also, 

there have been protocols added to the 

information collection request. Form 

Number: CMS–10436 (OCN: 0938– 

New); Frequency: Yearly; Affected 

Public: Individuals and households; 

Number of Respondents: 472; Total 

Annual Responses: 472; Total Annual 

Hours: 478 (For policy questions 

regarding this collection contact 

Suzanne Goodwin at 410–786–0226. For 

all other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: CMS Enterprise 

Identity Management System; Use: The 

Enterprise Identity Management (EIDM) 

solution will provide an enterprise-wide 

solution that will also support CMS’ 

senior management goal to improve the 

Provider and Health Information 

Exchange experience by providing an 

enterprise-wide set of credentials and 

single sign-on capability for multiple 

CMS applications. In order to prove the 

identity of an individual requesting 

electronic access to CMS protected 

information or services, CMS will 

collect a core set of attributes about that 

individual. These core attributes will be 

used to: 

1. Provide the identity proofing 

service sufficient data to establish that 

the individual’s identity is provable to 

a NIST assurance level; 

2. Store the approval information 

returned by the identity proofing 

service; 

3. Provide CMS with additional data 

for multi-factor identification (personal 

questions and answers); 

4. Provide the user a single sign-on, 

federated CMS EIDM ID and Password; 

5. Authenticate the user; and 

6. Authorize the user for application 

access. 

The information collected will be 

gathered and used solely by CMS and 

approved contractor(s) and state health 

insurance exchanges. Information 

confidentiality will conform to HIPAA 

and FISMA requirements. Respondents 

may also access CMS Terms of Service 

and CMS Privacy Statement on the Web. 

Form Numbers: CMS–10452 (OCN: 

0938–New); Frequency: Reporting—On 

occasion; Affected Public: Individuals 

and households; Number of Annual 

Respondents: 26,000,000; Total Annual 

Responses: 26,000,000; Total Annual 

Hours: 8,666,667. (For policy questions 

regarding this collection contact Robert 

Burger at 410–786–2125. For all other 

issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Children’s Health Insurance Program 

(CHIP) Report on Payables and 

Receivables; Use: Collection of 

Children’s Health Insurance Program 

(CHIP) data and the calculation of the 

CHIP Incurred But Not Reported (IBNR) 

estimate are pertinent to CMS’ financial 

audit. The Chief Financial Officer 

auditors have reported the lack of an 

estimate for CHIP IBNR payables and 

receivables as a reportable condition in 

the FY 2005 audit of CMS’s financial 

statements. It is essential that CMS 

collect the necessary data from State 

agencies in FY 2006, so that CMS 

continues to receive an unqualified 

audit opinion on its financial 

statements. Program expenditures for 

the CHIP have increased since its 

inception; as such, CHIP receivables and 

payables may materially impact the 

financial statements. The CHIP Report 

on Payables and Receivables will 

provide the information needed to 

calculate the CHIP IBNR; Form Number: 

CMS–10180 (OCN: 0938–0988); 

Frequency: Reporting—Annually; 

Affected Public: State, Local or Tribal 

governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 392. (For policy 

questions regarding this collection 

contact Michele Myers at 410–786– 

7911. For all other issues call 410–786– 

1326.) 


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24754 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 

5. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Medicaid Report on Payables and 

Receivables; Use: The Chief Financial 

Officers (CFO) Act of 1990, as amended 

by the Government Management Reform 

Act (GMRA) of 1994, requires 

government agencies to produce 

auditable financial statements. Because 

the Centers for Medicare & Medicaid 

Services (CMS) fulfills its mission 

through its contractors and the States; 

these entities are the primary source of 

information for the financial statements. 

There are three basic categories of data: 

Expenses, payables, and receivables. 

The CMS–64 is used to collect data on 

Medicaid expenses. The CMS–R–199 

collects Medicaid payable and 

receivable accounting data from the 

States. Form Number: CMS–R–199 

(OCN: 0938–0697); Frequency: 

Reporting—Annually; Affected Public: 

State, Local or Tribal governments; 

Number of Respondents: 56; Total 

Annual Responses: 56; Total Annual 

Hours: 336. (For policy questions 

regarding this collection contact 

Michele Myers at 410–786–7911. For all 

other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on May 28, 2013. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: April 23, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–09913 Filed 4–25–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0800] 

Guidance for Industry on Regulatory 

Classification of Pharmaceutical CoCrystals; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Regulatory Classification of 

Pharmaceutical Co-Crystals.’’ This 

guidance provides applicants of new 

drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) with the Center for Drug 

Evaluation and Research’s (CDER’s) 

current thinking on the appropriate 

regulatory classification of 

pharmaceutical co-crystal solid-state 

forms. This guidance also provides 

information about the data the applicant 

should submit to support the 

appropriate classification of a co-crystal, 

as well as the regulatory implications of 

the classification. 

The recommendations in this 

guidance apply to materials that the 

Agency has not previously evaluated 

and determined to be pharmaceutical 

co-crystals. The recommendations do 

not apply to materials that the Agency 

has previously designated as salts, 

complexes, or other non-co-crystalline 

forms. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance 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. 

FOR FURTHER INFORMATION CONTACT: 

Andre Raw, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, Metro Park North II, 

7500 Standish Pl., Rockville, MD 

20855, 240–276–8500; or 

Richard Lostritto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 21, rm. 

1626, 10903 New Hampshire Ave., 

Silver Spring, MD 20993, 301–796– 

1900. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Regulatory Classification of 

Pharmaceutical Co-Crystals.’’ This 

guidance provides applicants of NDAs 

and ANDAs with CDER’s current 

thinking on the appropriate regulatory 

classification of pharmaceutical cocrystal solid-state forms. This guidance 

also provides information about the data 

the applicant should submit to support 

the appropriate classification of a cocrystal, as well as the regulatory 

implications of the classification. 

On December 2, 2011 (76 FR 75551), 

FDA announced the availability of the 

draft version of this guidance. The 

public comment period closed on March 

1, 2012. A number of comments were 

received from the public, all of which 

the Agency considered carefully as it 

finalized the guidance and made 

appropriate changes. Any changes to the 

guidance were minor and made to 

clarify statements in the draft guidance. 

Co-crystals are solids that are 

crystalline materials composed of two or 

more molecules in the same crystal 

lattice. These solid-state forms, 

composed of an active pharmaceutical 

ingredient (API) with a neutral guest 

compound (also referred to as a 

conformer), have been the focus of 

significant interest in drug product 

development. Pharmaceutical cocrystals have opened the opportunity for 

engineering solid-state forms designed 

to have tailored properties to enhance 

drug product bioavailability and 

stability, as well as enhance 

processability of the solid material 

inputs in drug product manufacture. 

Pharmaceutical co-crystals are of 

interest because they offer the advantage 

of generating a diverse array of solidstate forms from APIs that lack ionizable 

functional groups needed for salt 

formation. 

Traditionally, solid-state polymorphic 

forms of an API are classified as either 

crystalline, amorphous, or solvate and 

hydrate forms, and applicable regulatory 

schemes for these solid-state 

polymorphic forms are well-defined. 

Co-crystals, however, are 

distinguishable from these traditional 

pharmaceutical solid-state forms. Unlike 


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