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
13010 Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Postmarketing Adverse Drug 

Experience Reporting (OMB Control 

Number 0910–0230)—(Extension) 

Sections 201, 502, 505, and 701 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 321, 352, 355, and 371) 

require that marketed drugs be safe and 

effective. In order to know whether 

drugs that are not safe and effective are 

on the market, FDA must be promptly 

informed of adverse experiences 

associated with the use of marketed 

drugs. In order to help ensure this, FDA 

issued regulations at §§ 310.305 and 

314.80 (21 CFR 310.305 and 314.80) to 

impose reporting and recordkeeping 

requirements on the drug industry that 

would enable FDA to take the action 

necessary to protect the public health 

from adverse drug experiences. 

All applicants who have received 

marketing approval of drug products are 

required to report to FDA serious, 

unexpected adverse drug experiences 

(‘‘15-day Alert reports’’), as well as 

follow up reports (§ 314.80(c)(1)). This 

includes reports of all foreign or 

domestic adverse experiences as well as 

those based on information from 

applicable scientific literature and 

certain reports from postmarketing 

studies. Section 314.80(c)(1)(iii) pertains 

to such reports submitted by nonapplicants. 

Under § 314.80(c)(2), applicants must 

provide periodic reports of adverse drug 

experiences. A periodic report includes, 

for the reporting interval, reports of 

serious, expected adverse drug 

experiences and all nonserious adverse 

drug experiences and an index of these 

reports, a narrative summary and 

analysis of adverse drug experiences, an 

analysis of the 15-day Alert reports 

submitted during the reporting interval, 

and a history of actions taken because 

of adverse drug experiences. Under 

§ 314.80(i), applicants must keep for 10 

years records of all adverse drug 

experience reports known to the 

applicant. 

For marketed prescription drug 

products without approved new drug 

applications or abbreviated new drug 

applications, manufacturers, packers, 

and distributors are required to report to 

FDA serious, unexpected adverse drug 

experiences as well as follow-up reports 

(§ 310.305(c)). Section 310.305(c)(5) 

pertains to the submission of follow-up 

reports to reports forwarded to the 

manufacturers, packers, and distributors 

by FDA. Under § 310.305(f), each 

manufacturer, packer, and distributor 

shall maintain for 10 years records of all 

adverse drug experiences required to be 

reported. 

The primary purpose of FDA’s 

adverse drug experience reporting 

system is to enable identification of 

signals for potentially serious safety 

problems with marketed drugs. 

Although premarket testing discloses a 

general safety profile of a new drug’s 

comparatively common adverse effects, 

the larger and more diverse patient 

populations exposed to the marketed 

drug provide the opportunity to collect 

information on rare, latent, and longterm effects. Signals are obtained from 

a variety of sources, including reports 

from patients, treating physicians, 

foreign regulatory agencies, and clinical 

investigators. Information derived from 

the adverse drug experience reporting 

system contributes directly to increased 

public health protection because the 

information enables FDA to make 

important changes to the product’s 

labeling (such as adding a new 

warning), decisions about risk 

evaluation and mitigation strategies or 

the need for postmarket studies or 

clinical trials, and when necessary, to 

initiate removal of a drug from the 

market. 

Respondents to this collection of 

information are manufacturers, packers, 

distributors, and applicants. The 

following estimates are based on FDA’s 

knowledge of adverse drug experience 

reporting, including the time needed to 

prepare the reports, and the number of 

reports submitted to the Agency. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

310.305(c)(5) ......................................... 3 1 3 1 3 

314.80(c)(1)(iii) ....................................... 5 1 5 1 5 

314.80(c)(2) ........................................... 724 19.33 13,996 60 839,760 

Total ................................................ .............................. .............................. .............................. .............................. 839,768 

1The reporting burden for § 310.305(c)(1), (c)(2), and (c)(3), and § 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910–0291. 

2The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 13011 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

21 CFR section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

310.305(f) ............................................... 25 1 25 16 400 

314.80(i) ................................................. 724 508 367,959 16 5,887,344 

Total ................................................ .............................. .............................. .............................. .............................. 5,887,744 

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

2There are maintenance costs of approximately $22,000 annually. 

Dated: March 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05591 Filed 3–11–15; 8:45 am] 

BILLING CODE 4164–01–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 

DP15–007, Effectiveness of Teen 

Pregnancy Prevention Programs 

Designed Specifically for Young Males. 

Time and Date: 9:00 a.m.—6:00 p.m., April 

7–9, 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 ‘‘Effectiveness of Teen Pregnancy 

Prevention Programs Designed Specifically 

for Young Males’’, DP15–007. 

Contact Person for More Information: M. 

Chris Langub, Ph.D., Scientific Review 

Officer, CDC, 4770 Buford Highway, NE., 

Mailstop F–80, Atlanta, Georgia 30341, 

Telephone: (770) 488–3585, EEO6@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. 2015–05575 Filed 3–11–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–0990—New– 

60D] 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

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

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, announces plans 

to submit a new Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, OS seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on the ICR must be 

received on or before May 11, 2015. 

ADDRESSES: Submit your comments to 

Information.CollectionClearance@

hhs.gov or by calling (202) 690–6162. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@

hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

document identifier HHS–OS–0990— 

New–60D for reference. 

Information Collection Request Title: 

HHS Entrepreneurs-in-Residence 

Program (EIR). 

Abstract: The HHS IDEA Lab, in the 

Immediate Office of the Secretary, is 

requesting an approval by Office of 

Management and Budget (OMB) on a 

new information collection, which is 

critical to the success of the HHS EIR 

program, and identifies private sector 

entrepreneurs with unique skill sets not 

available in government to join HHS for 

a year to work on critical initiatives. The 

information collection for the HHS EIR 

custom form management system 

involves obtaining candidate resumes 

and responses to short essay questions 

specifically designed to determine 

whether entrepreneurs have the 

knowledge, skills and abilities to 

successfully complete HHS EIR projects 

in the government context and mentor 

existing government staff to acquire 

new, entrepreneurial skills. 

Likely Respondents: The candidate 

pools, targeted for the HHS EIR program 

are serial private sector entrepreneurs 

with no prior federal government 

experience. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

HHS EIR Application ....................................................................................... 150 1 1 150 

Total .......................................................................................................... 150 1 1 150 


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