Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 64391 

adoptive placements based on the race, 

color, or national origin of any of the 

individuals involved. The enforcement 

provisions include the execution and 

completion of corrective action plans 

when a state is in violation of section 

471(a)(18) of the Act. The information 

collection is needed: (1) To ensure 

compliance with title IV–E foster care 

eligibility requirements; (2) to monitor 

state plan requirements under titles IV– 

B and IV–E of the Act, as required by 

federal statute; and (3) to enforce the 

title IV–E anti-discrimination 

requirements through state corrective 

action plans. The resultant information 

will allow ACF to determine if states are 

in compliance with state plan 

requirements and are achieving desired 

outcomes for children and families, help 

ensure that claims by states for title IV– 

E funds are made only on behalf of title 

IV–E eligible children, and require 

states to revise applicable statutes, rules, 

policies and procedures, and provide 

proper training to staff, through the 

development and implementation of 

corrective action plans. These reviews 

not only address compliance with 

eligibility requirements but also assist 

states in enhancing the capacities to 

serve children and families. In 

computing the number of burden hours 

for this information collection, ACF 

based the annual burden estimates on 

ACF’s and states’ experiences in 

conducting reviews and developing 

program improvement plans. 

Respondents: State Title IV–B and 

Title IV–E Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

45 CFR 1356.7(i) Program Improvement Plan (FCER) .................................. 2 1 90 180 

45 CFR 1366.33(b) Statewide Assessment (CFSR) ....................................... 13 1 120 1,560 

45 CFR 1355.33(c) On-site Review (CFSR) ................................................... 13 1 1,186 15,418 

45 CFR 1355.35(a) Program Improvement Plan (CFSR) ............................... 13 1 300 3,900 

45 CFR 1355.38(b) and (c) Corrective Action ................................................. 1 1 780 780 

Estimated Total Annual Burden 

Hours: 21,838. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV, Attn: Desk Officer for 

the Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–25644 Filed 10–28–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Intergovernmental Reference 

Guide (IRG). 

OMB No.: 0970–0209. 

Description: The Intergovernmental 

Reference Guide (IRG) is a centralized 

and automated repository of state and 

tribal profiles, which contains highlevel descriptions of each state and 

tribe’s child support enforcement (CSE) 

program. These profiles provide state 

and tribal CSE agencies, and foreign 

countries with an effective and efficient 

method for updating and accessing 

information needed to process 

intergovernmental child support cases. 

The IRG information collection 

activities are authorized by: (1) 42 

U.S.C. 652(a)(7), which requires OCSE 

to provide technical assistance to state 

child support enforcement agencies to 

help them establish effective systems for 

collecting child and spousal support; (2) 

42 U.S.C. 666(f), which requires states to 

enact the Uniform Interstate Family 

Support Act; and (3) 45 CFR 303.7, 

which requires state child support 

agencies to provide services in 

intergovernmental cases. 

Respondents: All state and tribal CSE 

agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Intergovernmental Referral Guide: State Profile Guidance—(States and Territories) ......................................................................................................... 54 18 0.30 291.60 

Intergovernmental Referral Guide: Tribal Profile Guidance ............................ 60 18 0.30 324.00 

Estimated Total Annual Burden 

Hours: 615.60. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

mstockstill on DSK4VPTVN1PROD with NOTICES

64392 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 

1Please note that throughout the regulations 

referenced in relation to these information 

collections, licensed biological products refers to 

biologics licensed under any provision of section 

351 of the PHS Act. 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–25684 Filed 10–28–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0231] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

28, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0308. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adverse Experience Reporting for 

Licensed Biological Products; and 

General Records—21 CFR Part 600— 

(OMB Control Number 0910–0308)— 

Extension 

Under the Public Health Service 

(PHS) Act (42 U.S.C. 262), FDA may 

only approve a biologics license 

application for a biological product that 

is safe, pure, and potent. When a 

biological product is approved and 

enters the market, the product is 

introduced to a larger patient 

population in settings different from 

clinical trials. New information 

generated during the postmarketing 

period offers further insight into the 

benefits and risks of the product, and 

evaluation of this information is 

important to insure its safe use. FDA 

issued the Adverse Experience 

Reporting (AER) requirements in part 

600 (21 CFR part 600) to enable FDA to 

take actions necessary for the protection 

of the public health in response to 

reports of adverse experiences related to 

licensed biological products.1

The primary purpose of FDA’s AER 

system is to identify potentially serious 

safety problems with licensed biological 

products. Although the premarket 

approval process is meant to disclose a 

general safety profile of a biological 

product’s comparatively common 

adverse effects, the larger and more 

diverse patient populations exposed to 

the licensed biological product provides 

the opportunity to collect information 

on rare, latent, and long-term effects. In 

addition, production and/or distribution 

problems have contaminated biological 

products in the past. AER reports are 

obtained from a variety of sources, 

including manufacturers, patients, 

physicians, foreign regulatory agencies, 

and clinical investigators. Identification 

of new and unexpected safety issues 

through the analysis of the data in AERS 

contributes directly to increased public 

health protection. For example, 

evaluation of these safety issues enables 

FDA to take focused regulatory action. 

Such action may include, but is not 

limited to, important changes to the 

product’s labeling (such as adding a 

new warning), coordination with 

manufacturers to ensure adequate 

corrective action is taken, and removal 

of a biological product from the market 

when necessary. 

Section 600.80(c)(1) requires licensed 

manufacturers or any person whose 

name appears on the label of a licensed 

biological product to report each 

adverse experience that is both serious 

and unexpected, whether foreign or 

domestic, as soon as possible but in no 

case later than 15 calendar days of 

initial receipt of the information by the 

licensed manufacturer. These reports 

are known as postmarketing 15-day 

Alert reports. This section also requires 

licensed manufacturers to submit any 

follow-up reports within 15 calendar 

days of receipt of new information or as 

requested by FDA, and if additional 

information is not obtainable, to 

maintain records of the unsuccessful 

steps taken to seek additional 

information. In addition, this section 

requires a person who submits an 

adverse action report to the licensed 

manufacturer, rather than FDA, to 

maintain a record of this action. 

Section 600.80(e) requires licensed 

manufacturers to submit a 15-day Alert 

report for an adverse experience 

obtained from a postmarketing clinical 

study only if the licensed manufacturer 

concludes that there is a reasonable 

possibility that the product caused the 

adverse experience. Section 600.80(c)(2) 

requires licensed manufacturers to 

report each adverse experience not 

reported in a postmarketing 15-day 

Alert report at quarterly intervals, for 3 

years from the date of issuance of the 

biologics license, and then at annual 

intervals. The majority of these periodic 

reports are submitted annually since a 

large percentage of currently licensed 

biological products have been licensed 

longer than 3 years. Section 600.80(i) 

requires licensed manufacturers to 

maintain for a period of 10 years records 

of all adverse experiences known to the 

licensed manufacturer, including raw 

data and any correspondence relating to 

the adverse experiences. Section 600.81 

requires licensed manufacturers to 

submit, at an interval of every 6 months, 

information about the quantity of the 

product distributed under the biologics 

mstockstill on DSK4VPTVN1PROD with NOTICES