13008 Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 

or other forms of information 

technology to minimize the information 

collection burden. 

Terry S. Clark, 

Deputy Information Collection Clearance 

Officer. 

[FR Doc. 2015–05619 Filed 3–11–15; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

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 a meeting for the initial 

review of applications in response to 

[(FOA) GH15–001, Conducting Public 

Health Research in Kenya, Funding 

Opportunity Announcement. 

Time and Date: 12:00 p.m.—5:00 p.m., 

April 1, 2015 (Closed). 

Place: Teleconference. 

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. 

Matters for Discussion: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Conducting Public Health 

Research in Kenya, FOA GH15–001’’. 

Contact Person for More Information: 

Hylan Shoob, Scientific Review Officer, 

Center for Global Health (CGH) Science 

Office, CGH, CDC, 1600 Clifton Road, NE., 

Mailstop D–69, Atlanta, Georgia 30033, 

Telephone: (404) 639–4796. 

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. 2015–05577 Filed 3–11–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

2015 Parenteral Drug Association/Food 

and Drug Administration Joint 

Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA), is announcing a public 

conference, to be held in co-sponsorship 

with the Parenteral Drug Association 

(PDA), entitled ‘‘Mission Possible: 

Patient-Focused Manufacturing, 

Quality, and Regulatory Solutions.’’ The 

conference will cover current issues 

affecting the industry as well as explore 

strategies to facilitate the development 

and continuous improvement of safe 

and effective medical products. The 

conference establishes a unique forum 

to discuss the foundations, emerging 

technologies, and innovations in 

regulatory science, as well as the current 

quality and compliance areas of 

concerns. Meeting participants will hear 

from FDA and industry speakers about 

the requirements and best practices to 

consider while implementing robust 

quality systems in order to deliver the 

best quality product. 

Date and Time: The public conference 

will be held on September 28, 2015, 

from 7 a.m. to 7:30 p.m.; September 29, 

2015, from 7 a.m. to 9:30 p.m.; and 

September 30, 2015, from 7 a.m. to 

12:30 p.m. 

Location: The public conference will 

be held at the Renaissance Washington 

Hotel, 999 Ninth Street NW., 

Washington, DC 20001, 202–898–9000, 

FAX: 202–289–0947. 

Contact: Wanda Neal, Parenteral Drug 

Association, PDA Global Headquarters, 

Bethesda Towers, 4350 East West Hwy., 

Suite 150, Bethesda, MD 20814, 301– 

656–5900, ext. 111, FAX: 301–986– 

1093, email: info@pda.org; or Ken 

Nolan, Office of Communications, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–8629, email: 

kenneth.nolan@fda.hhs.gov. 

Accommodations: Attendees are 

responsible for their own 

accommodations. To make reservations, 

contact the Renaissance Washington 

Hotel (see Location) and reference ‘‘the 

2015 PDA/FDA Joint Regulatory 

Conference’’ to receive the PDA group 

rate. Room rates are: Single: $305 plus 

14.5 percent State and local taxes. 

Requests will be processed on a firstcome, first-served basis. 

Registration: Attendees are 

encouraged to register at their earliest 

convenience. The PDA registration fees 

cover the cost of facilities, materials, 

and refreshments. Seats are limited; 

please submit your registration as soon 

as possible. Conference space will be 

filled in order of receipt of registration. 

Those accepted for the conference will 

receive confirmation. Registration will 

close after the conference is filled. 

Onsite registration will be available on 

a space available basis beginning at 1 

p.m. on September 27, 2015, and at 7 

a.m. from September 28 through 30, 

2015. The cost of registration is as 

follows: 

COST OF REGISTRATION

Affiliation Before July 

19, 2015 

July 19– 

August 18, 

2015 

After August 

18, 2015 

Premier Package (Includes Conference and Workshop Registration) 

Member .................................................................................................................................................... $3,240 $3,490 $3,740 

Nonmember ............................................................................................................................................. 3,599 3,849 4,099 

Conference Only 

Member .................................................................................................................................................... 1,895 2,095 2,295 

Nonmember ............................................................................................................................................. 2,154 2,354 2,554 

Government/Health Authority Member .................................................................................................... 700 700 700 

Government/Health Authority Nonmember * ........................................................................................... 800 800 800 

Academic Member ................................................................................................................................... 700 700 700 

Academic Nonmember * .......................................................................................................................... 800 800 800 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 13009 

COST OF REGISTRATION—Continued 

Affiliation Before July 

19, 2015 

July 19– 

August 18, 

2015 

After August 

18, 2015 

Student Member ...................................................................................................................................... 280 280 280 

Student Nonmember * .............................................................................................................................. 310 310 310 

* For this member type, online registration is not available and must be faxed in. 

Please visit PDA’s Web site: 

www.pda.org/pdafda2015 to confirm 

the prevailing registration fees. (FDA 

has verified the Web site address, but 

FDA is not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

If you need special accommodations 

due to a disability, please contact 

Wanda Neal (see Contact), at least 7 

days in advance of the conference. 

Registration Instructions: To register, 

please submit your name, affiliation, 

mailing address, telephone, fax number, 

and email address, along with a check 

or money order payable to ‘‘PDA.’’ Mail 

to: PDA, Global Headquarters, Bethesda 

Towers, 4350 East West Hwy., Suite 

150, Bethesda, MD 20814. To register 

via the Internet, go to PDA’s Web site: 

www.pda.org/pdafda2015. 

The registrar will also accept payment 

by major credit cards (VISA/American 

Express/MasterCard only). For more 

information on the meeting, or for 

questions on registration, contact PDA 

(see Contact). 

Transcripts: As soon as a transcript is 

available, it can be obtained in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(ELEM–1029), Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The PDA/ 

FDA Joint Regulatory Conference offers 

the unique opportunity for participants 

to join FDA representatives and 

industry experts in face-to-face 

dialogues. Each year, FDA speakers 

provide updates on current efforts 

affecting the development of global 

regulatory strategies, while industry 

professionals from pharmaceutical 

companies present case studies on how 

they employ global strategies in their 

daily processes. 

Through a series of sessions and 

meetings, the conference will provide 

participants with the opportunity to 

hear directly from FDA experts and 

representatives of global regulatory 

authorities on best practices, including: 

• Product Quality 

• Data Integrity 

• Breakthrough Therapies 

• Regulatory Challenges and 

Opportunities 

• Lifecycle Management 

• Clinically Relevant Specifications 

• Food and Drug Administration 

Safety and Innovation Act 

• Quality Metrics/Quality Culture 

• Manufacturing of the Future With 

Submissions 

• Continuous Verification and 

Validation 

• Continuous Manufacturing 

• ‘‘Fishbowl’’ Role Play 

• Quality Systems 

• Contract Manufacturing 

Organizations 

• Maturity of Quality Systems 

• Investigations 

• Case Studies for Quality 

• Quality Submissions 

• Prescription Drug User Fee Act 

• Risk-Based Control Strategies 

• Supply Chain 

• Quality Risk Management Systems 

• Drug Shortages 

• Customer Complaint Reviews and 

Trending 

• Human Factors 

• Office of Pharmaceutical Quality 

and Program Alignment Group 

• Patient Perspective 

• Compliance Update 

• Center Initiatives—Regulatory 

Submission Update 

To help ensure the quality of FDAregulated products, the workshop helps 

to achieve objectives set forth in section 

406 of the FDA Modernization Act of 

1997 (21 U.S.C. 393), which includes 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The workshop also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

government agencies to small 

businesses. 

Dated: March 4, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05513 Filed 3–11–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0253] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Adverse Drug Experience Reporting 

and Recordkeeping Biological 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

FDA’s postmarketing adverse drug 

experience reporting and recordkeeping 

requirements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 11, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 


asabaliauskas on DSK5VPTVN1PROD with NOTICES