Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3053 

entering the building. We note that all 

items brought into CMS, whether 

personal or for the purpose of 

presentation or to support a 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

presentation or to support a 

presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. All visitors must 

be escorted in areas other than the lower and 

first floor levels in the Central Building. 

Authority: 5 U.S.C. App. 2, section 10(a). 

Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program. 

Dated: January 9, 2009. 

Barry M. Straube, 

Chief Medical Officer and Director, Office 

of Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services. 

[FR Doc. E9–943 Filed 1–15–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Statement of Mission, Organization, 

Functions, and Delegations of 

Authority 

This notice amends Part K of the 

Statement of Mission, Organization, 

Functions, and Delegations of Authority 

of the Department of Health and Human 

Services (HHS), Administration for 

Children and Families (ACF), as 

follows: Chapter KE, Administration for 

Native Americans (ANA), as last 

amended in 60 FR 17084–85, 04/04/95. 

This notice establishes the Division of 

Policy, Planning and Evaluation and 

moves the support staff function to the 

Office of the Commissioner. The 

changes are as follows: 

I. Chapter KE. Administration for 

Native Americans 

A. Delete KE. 00 Mission in its 

entirety and replace with the following: 

KE. 00 Mission. The mission of the 

Administration for Native Americans is 

to promote the goal of self-sufficiency 

and cultural preservation for Native 

Americans by providing social and 

economic development opportunities 

through financial assistance, training, 

and technical assistance to eligible 

Tribes and Native American 

communities, including American 

Indians, Alaska Natives, Native 

Hawaiians, and other Native Pacific 

Islander organizations. ANA provides 

funding for community-based projects 

that are designed to improve the lives of 

Native children and families and reduce 

long-term dependency on public 

assistance. Competitive funding 

authorized under the Native American 

Programs Act of 1974, as amended, for 

community-based projects is provided 

through three competitive discretionary 

grant programs to eligible Tribes and 

non-profit Native American 

organizations: Social and economic 

development, language preservation, 

and environmental regulatory 

enhancement. 

B. Delete KE. 10 Organization in its 

entirety and replace with the following: 

KE.10 Organization. The 

Administration for Native Americans is 

headed by a Commissioner who is 

confirmed by the Senate and reports 

directly to the Assistant Secretary for 

Children and Families. 

The ANA organization includes the: 

Office of the Commissioner (KEA); IntraDepartmental Council on Native 

American Affairs (KEB); Division of 

Program Operations (KEC); Division of 

Policy, Planning and Evaluation (KED). 

C. Delete KE.20 Functions in its 

entirety and replace with the following: 

KE. 20 Functions 

A. The Office of the Commissioner 

provides executive leadership and 

management strategies for all 

components of ANA. As required by 

statute, the Commissioner is Chair of the 

Intra-Departmental Council on Native 

American Affairs and advises the 

Secretary on all matters affecting Native 

Americans that involve the Department. 

The Commissioner serves as an effective 

and visible advocate on behalf of Native 

Americans within the Department, and 

with other departments and agencies of 

the Federal Government regarding all 

Federal policies affecting Native 

Americans. The Commissioner provides 

policy direction and guidance to ACF 

Regional Offices with respect to 

programs for Urban Indians, offReservation Indians, and other Native 

American projects in Hawaii and the 

Pacific Islands. The Commissioner 

oversees the Native Hawaiian Revolving 

Loan Fund administered by the Office of 

Hawaiian Affairs. In the absence of the 

Commissioner, the Deputy 

Commissioner is responsible for all 

organizational management. 

The Management Operations Staff 

(MOS) is responsible for ANA Budget 

and Administrative functions. MOS 

coordinates ANA budget activities, the 

ANA funding decision memo, data 

collection, personnel actions, ANA’s 

electronic library, tracking of required 

grant reports, and oversees contract 

expenditures. The staff members control 

the flow of correspondence, including 

receipt of and response to Freedom of 

Information Act requests. 

B. The Commissioner is the Chair of 

the Intra-Departmental Council on 

Native American Affairs (ICNAA) and 

advises the Secretary on Native 

American issues. ICNAA staff members 

provide support to the Commissioner. 

ICNAA develops and promotes HHS 

policy to provide greater access and 

quality services for American Indians, 

Alaska Natives, and Native Americans 

(AI/AN/NAs) throughout the 

Department and where possible, the 

Federal Government; promotes 

implementation of HHS policy and 

agency plans on consultation with AI/ 

AN/NAs and Tribal Governments; 

identifies and develops legislative, 

administrative, and regulatory proposals 

that promotes an effective, meaningful 

AI/AN/NA policy to improve health and 

human services for AI/AN/NAs; 

identifies and develops comprehensive 

Departmental strategy proposal to 

promote self-sufficiency and selfdetermination for all AI/AN/NA people; 

and promotes the Tribal/Federal 

government-to-government relationship 

on a Department-wide basis in 

accordance with Presidential Executive 

Order. 

C. The Division of Program 

Operations (DPO) is responsible for the 

administration of discretionary grant 

programs to eligible Tribes and nonprofit Native American organizations. 

The responsibilities include (1) Annual 

grant competitions and coordination of 

the panel review process, (2) 

development of ANA’s Program 

Announcements, (3) grant oversight, 

and (4) grant close-out procedures. The 

DPO also manages and coordinates 

activities that support the ACF Native 

American Affairs Workgroup. 

D. The Division of Policy, Planning 

and Evaluation (DPPE) is responsible for 

development of organizational policies 

and planning; community impact 

evaluation; management of quarterly 

grantee project assessment; oversight of 

training and technical contracts; 

coordination of training and technical 

assistance activities in Alaska, the 

Pacific Basin, and the lower forty-eight 

states; development of organizational 

and Congressional reports; and 

completion of special organizational 

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3054 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

studies. In coordination with the Office 

of Planning, Research and Evaluation, 

DPPE coordinates ANA’s performance 

goals. 

Dated: January 9, 2009. 

Daniel C. Schneider, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. E9–983 Filed 1–15–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0001] 

Draft Guidance for Industry on 

Standards for Securing the Drug 

Supply Chain—Standardized 

Numerical Identification for 

Prescription Drug Packages; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Standards for 

Securing the Drug Supply Chain— 

Standardized Numerical Identification 

for Prescription Drug Packages.’’ This 

draft guidance is being issued under the 

Federal Food, Drug, and Cosmetic Act 

(the act), which requires FDA to develop 

standardized numerical identifiers for 

prescription drugs. We are also 

requesting responses from interested 

stakeholders to questions posed in this 

Federal Register notice related to the 

draft guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by April 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Submit written 

comments on the draft guidance 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Ilisa B.G. Bernstein, Office of the 

Commissioner/Office of Policy, 

Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796– 

4840, e-mail: 

ilisa.bernstein@fda.hhs.gov; 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 301–827– 

6210, e-mail: 

Stephen.ripley@fda.hhs.gov; 

Jennifer Devine, Center for Drug 

Evaluation and Research, 10903 

New Hampshire Ave.,Silver Spring, 

MD 20993–0002, 301–796–3347, email: Jennifer.devine@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Draft Guidance for Industry on 

Standards for Securing the Drug Supply 

Chain—Standardized Numerical 

Identification for Prescription Drug 

Packages.’’ On September 27, 2007, the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85) was signed into 

law. Section 913 of this legislation 

created section 505D of the act, which 

requires the Secretary of Health and 

Human Services (the Secretary) to 

develop standards and identify and 

validate effective technologies for the 

purpose of securing the drug supply 

chain against counterfeit, diverted, 

subpotent, substandard, adulterated, 

misbranded, or expired drugs. Section 

505D of the act directs the Secretary to 

consult with specific entities to 

prioritize and develop standards for 

identification, validation, 

authentication, and tracking and tracing 

of prescription drugs. No later than 30 

months after the date of enactment of 

FDAAA, the statute also directs the 

Secretary to develop a standardized 

numerical identifier (SNI) to be applied 

to a prescription drug at the point of 

manufacturing and repackaging at the 

package or pallet level, sufficient to 

facilitate the identification, validation, 

authentication, and tracking and tracing 

of the prescription drug. An SNI applied 

at the point of repackaging is to be 

linked to the SNI applied at the point of 

manufacturing, and to the extent 

practicable, the SNI should be 

harmonized with international 

consensus standards for such an 

identifier. (See section 505D(b)(2) of the 

act.) The provisions in section 505D(b) 

of the act complement and build on 

FDA’s longstanding efforts to further 

secure the U.S. drug supply. 

FDA sought public comment on 

specific questions related to 

development of an SNI. We received 59 

comments from a range of stakeholders 

including manufacturers, wholesalers, 

pharmacies, trade and health 

professional organizations, technology 

vendors, health professionals, 

consumers, and state governments. The 

standards included in this draft 

guidance are based on information 

received in response to our request for 

comment and the agency’s familiarity 

with identification standards already in 

use for certain prescription biologics. 

This draft guidance addresses only 

package-level SNI. Linking of a 

repackager SNI to a manufacturer SNI is 

not addressed in this guidance. 

Additionally, standards for track and 

trace, authentication, and validation are 

not included in this guidance. This draft 

guidance is intended to be the first of 

several guidances and regulations that 

FDA may issue to implement section 

505D of the act; issuance of this 

guidance is intended to assist with the 

development of standards and systems 

for identification, authentication, and 

tracking and tracing of prescription 

drugs. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on Standards for Drug Supply Chain 

Security—Standardized Numerical 

Identification for Prescription Drug 

Packages. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Request for Information 

To assist us in finalizing the draft 

guidance and aid us in future guidance 

development and rulemaking related to 

section 505D of the act, we are seeking 

responses from interested stakeholders 

on the following questions. We also 

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