4912 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 

42 U.S.C. 1395b–6 

Gene L. Dodaro, 

Comptroller General of the United States. 

[FR Doc. 2016–01264 Filed 1–27–16; 8:45 am] 

BILLING CODE 1610–02–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 80 FR 76493–76499, 

dated December 9, 2015) is amended to 

reflect the reorganization of the Division 

of Communication Services, Office of 

the Associate Director for 

Communication, Centers for Disease 

Control and Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the title and the 

mission and function statements for the 

Division of Communication Services 

(CAUD) and insert the following: 

Division of Communication Services 

(CAUD). The Division of 

Communication Services (DCS) 

provides agency-wide CDC graphics, 

broadcast, photography, translation, 

interpretation, public information, and 

communication consultation/analysis 

leadership and support. To carry out its 

mission, the division performs the 

following functions: (1) Ensures 

broadcast functionality/broadcast 

engineering support including 

connectivity among physical assets such 

as the Global Communications Center, 

Emergency Operations Center, and 

continuity of operations for CDC; (2) 

develops and disseminates video and 

audio production; (3) manages CDC 

graphic design and production services 

including CDC branding and identity 

standards; (4) supports new broadcast 

communication mechanisms (e.g. HHS 

TV, CDC TV, radio/TV broadcast, 

podcast, webcast, and videos-ondemand) for CDC programs; (5) provides 

support for broadcast delivery press 

conferences and media interviews; (6) 

provides scientific and events 

photography; (7) provides multilingual 

translation and interpretation, and cross 

cultural communication assistance to 

Centers, Institute and Offices (CIOs) 

across CDC; (8) provides consultation 

and analysis of consumer research data 

to CIOs used for developing and 

evaluating health communication and 

marketing to specific audiences; (9) 

manages day-to-day operations of 

meeting space within CDC’s meeting 

center, the Global Communications 

Center; and (10) manages CDC–INFO 

(CDC’s telephone, email, and 

publications fulfillment services center); 

(11) oversees the agency-wide print 

management program; (12) manages 

CDC-wide information services 

including electronic and postal 

distribution lists, and electronic 

announcements; and (13) provides 

writer-editor services on behalf of CDC 

Office of the Director. 

Office of the Director (CAUD1). (1) 

Develops the strategic priorities and 

manages the program activities of the 

division; (2) provides leadership for 

ensuring all DCS products are of the 

highest quality; (3) helps CIOs use 

existing or develop new mechanisms for 

communicating with the public and 

CDC partners; (4) coordinates support 

for meetings held in the Global 

Communications Center with internal 

and external customers; (5) coordinates 

the use of the CDC exhibit for public 

health conferences; (6) manages overall 

IT-related functions for the division, 

including Create-IT (DCS’ online 

internal tracking and triage system), 

Trados SDL (translation memory 

application), and CDC–INFO IT 

applications; (7) provides and manages 

multi-year, multi-vendor CDC-wide 

communication contracts mechanism 

for use by CIO clients; (8) updates and 

manages Create-IT system for tracking 

and triage of work requests including 

associated customer satisfaction and 

other performance metrics for internal 

and external (CIO) use; (9) oversees the 

agency-wide print management 

program; (10) manages CDC-wide 

information services including 

electronic distribution lists, and 

electronic announcements; (11) 

administers CDC wide multi-year, 

multi-vendor communication contracts 

mechanism; (12) advises on methods for 

gaining public input on health issues 

and priorities (e.g., advisory 

mechanisms, focus groups, polling, 

legislative, and media tracking); (13) 

manages contract resources and 

provides analysis relative to audience 

segmentation and behavior, and (14) 

provides agency-wide multi-lingual 

service (MLS) support to include direct 

Spanish language translation, 

facilitating and coordinating support for 

other languages, and cross-cultural 

communication assistance as well as 

MLS leadership (e.g. implementation of 

agency Language Access Plan). 

Broadcast Services Branch (CAUDB). 

(1) Develops and produces audio, video, 

and multi-media health information 

products; (2) provides CDC with global 

communication capacity for highdefinition broadcast, webcast and 

emerging social and health media 

delivery channels; (3) supports the CDC 

Emergency Operations Center to provide 

response capacity and capability for 

emergency broadcasts; (4) develops and 

delivers health information broadcast 

programs in coordination with HHS for 

the public, including podcasts, CDC–TV 

and other channels; (5) creates and 

produces communication using new 

forms of social and electronic media; (6) 

collaborates with other areas of CDC to 

review and recommend potential audio 

and video technology; and (7) develops 

distance education, health 

communication, and training products 

to reach public health partners and 

professionals. 

Graphics Services Branch (CAUDC). 

(1) Leads and coordinates CDC visual 

information activities; (2) develops and 

produces graphic illustrations, 

including scientific posters, 

infographics, desktop published 

documents, visual presentations, 

conference materials, brochures and fact 

sheets, newsletters, and exhibits; (3) 

manages scientific and event 

photography; (4) provides creative 

direction and brand management 

guidance for graphics products and sets 

guidelines and standards for quality and 

consistency across the agency; (5) 

manages tracking and triage function 

within Create-IT system for management 

of work requests; and (6) provides 

technical assistance on large or 

multidisciplinary projects to provide a 

consistent approach across 

communication products. 

CDC–INFO and Print Services Branch 

(CAUDD). (1) Provides the public with 

accessible, accurate, and credible health 

information in English and Spanish, 24/ 

7, to include phone, email and U.S. 

mail; (2) ensures the CDC–INFO call 

center standards are kept for quality 

assurance, customer satisfaction, 

performance, and health impact when 

dealing with the public; (3) provides 

surge (to include 24/7) support through 

the 1–800 call center for public health 

emergencies and establishes policies 

and procedures with the CDC 

Emergency Operations Center, Joint 

Information Center; (4) manages CDC’s 

ordering and distribution facility for 

health publications; (5) liaisons with 

contract suppliers, the Government 


wgreen on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4913 

Printing Office, HHS, and other agencies 

on matters pertaining to print and 

publication procurement; (6) analyzes 

and reports CDC–INFO data to inform 

communication planning and programs 

throughout the agency; and (7) provides 

writer-editor support for the Office of 

the Director. 

Sherri A. Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2016–01676 Filed 1–27–16; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Bioequivalence 

Recommendations; Draft and Revised 

Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific bioequivalence (BE) 

recommendations. The 

recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site. The BE 

recommendations identified in this 

notice were developed using the process 

described in that 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 

either electronic or written comments 

on the draft guidance by March 28, 

2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Product-Specific 

Bioequivalence Recommendations; Draft 

and Revised Draft Guidances for 

Industry.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions: To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4730, 

Silver Spring, MD 20993–0002, 301– 

796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

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


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