73320 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

respondents’ current location and 

follow-up with respondents in the 

future. 

The Head Start Impact Study is a 

longitudinal study involving 4,667 firsttime enrolled three- and four-year-old 

preschool children across 84 nationally 

representative grantee/delegate agencies 

(in communities where there were more 

eligible children and families than can 

be served by the program). Participants 

were randomly assigned to either a 

Head Start group (that could enroll in 

Head Start services) or a control group 

(that could not enroll in Head services) 

or a control group (that could not enroll 

in Head Start services but could enroll 

in other available services selected by 

their parents). Data collection for the 

study began in fall of 2002 and has 

continued through late spring 2008 to 

include the participants’ 3rd grade year. 

Location and contact information for 

participants has continued every spring 

beginning in 2009 and continued 

through spring 2014. 

ACF will continue to collect a small 

amount of information for the sample 

through the spring of the participant’s 

12th grade year. To maintain adequate 

sample size, telephone interviews (with 

in-person follow-up as necessary) will 

be conducted in order to update the 

children’s status and their location and 

contact information. Additionally, the 

parent interview will include a small set 

of items on children’s special education 

needs, grade retention, school safety, 

school engagement, and parental 

monitoring to provide information on 

factors during adolescence that may 

influence long-term impacts of Head 

Start examined in a potential follow-up 

study. This information will be 

collected from parents or guardians in 

the spring of 2015 and 2016. Updates 

will take about 20 minutes to complete. 

Respondents: The original sample of 

4,667 treatment and control group 

members in the Head Start Impact 

Study, less 432 families that have given 

a ‘‘hard’’ refusal to participate in the 

study (e.g., refused to participate if they 

were contacted again). The number of 

respondents for this requested data 

collection is 4,235. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Parent Interview ................................................................... 8470 4235 1 1/3 1412 

Estimated Total Annual Burden 

Hours: 1412. 

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: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. Email address: 

OPREinfocollection@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, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration, for 

Children and Families. 

Naomi Goldstein, 

Director, Office of Planning, Research and 

Evaluation; Administration for Children and 

Families. 

[FR Doc. 2014–28843 Filed 12–9–14; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2029] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Practices and Procedures; Formal 

Evidentiary Public Hearing 

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 

reporting requirements contained in 

current FDA regulations: Administrative 

Practices and Procedures; Formal 

Evidentiary Public Hearing. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 9, 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 

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. 

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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73321 

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. 

Administrative Practices and 

Procedures (21 CFR 10.30, 10.33, 10.35, 

10.85); Formal Evidentiary Public 

Hearing (21 CFR 12.22, 12.45) (OMB 

Control Number 0910–0191)—Extension 

The Administrative Procedures Act (5 

U.S.C. 553(e)) provides that every 

Agency shall give an interested person 

the right to petition for issuance, 

amendment, or repeal of a rule. Section 

10.30 (21 CFR 10.30) sets forth the 

format and procedures by which an 

interested person may submit to FDA, in 

accordance with § 10.20 (21 CFR 10.20) 

(Submission of documents to Division 

of Dockets Management), a citizen 

petition requesting the Commissioner to 

issue, amend, or revoke a regulation or 

order, or to take or refrain from taking 

any other form of administrative action. 

The Commissioner may grant or deny 

such a petition, in whole or in part, and 

may grant such other relief or take other 

action as the petition warrants. 

Respondents are individuals or 

households, State or local governments, 

and not-for profit institutions or groups. 

Section 10.33 (21 CFR 10.33), issued 

under section 701(a) of the Federal, 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 371(a)), sets forth 

the format and procedures by which an 

interested person may request 

reconsideration of part or all of a 

decision of the Commissioner on a 

petition submitted under 21 CFR 10.25 

(Initiation of administrative 

proceedings). A petition for 

reconsideration must contain a full 

statement in a well-organized format of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision involved. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals of 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting from the 

Commissioner of FDA a reconsideration 

of a matter. 

Section 10.35 (21 CFR 10.35), issued 

under section 701(a) of the FD&C Act, 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20 (Submission 

of documents to Division of Dockets 

Management), the Commissioner to stay 

the effective date of any administrative 

action. 

Such a petition must do the following: 

(1) Identify the decision involved; (2) 

state the action requested, including the 

length of time for which a stay is 

requested; and (3) include a statement of 

the factual and legal grounds on which 

the interested person relies in seeking 

the stay. FDA uses the information 

provided in the request to determine 

whether to grant the petition for stay of 

action. 

Respondents to this information 

collection are interested persons who 

choose to file a petition for an 

administrative stay of action. 

Section 10.85 (21 CFR 10.85), issued 

under section 701(a) of the FD&C Act, 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20 (Submission 

of documents to Division of Dockets 

Management), an advisory opinion from 

the Commissioner on a matter of general 

applicability. An advisory opinion 

represents the formal position of FDA 

on a matter of general applicability. 

When making a request, the petitioner 

must provide a concise statement of the 

issues and questions on which an 

opinion is requested, and a full 

statement of the facts and legal points 

relevant to the request. Respondents to 

this collection of information are 

interested persons seeking an advisory 

opinion from the Commissioner on the 

Agency’s formal position for matters of 

general applicability. 

FDA has developed a method for 

electronic submission of citizen 

petitions. The Agency still allows for 

non-electronic submissions; however, 

electronic submissions of a citizen 

petition to a specific electronic docket 

presents a simpler and more 

straightforward approach. FDA has 

created a single docket on http://

www.regulations.gov, the U.S. 

Government’s consolidated docket Web 

site for Federal Agencies, for the initial 

electronic submission of all citizen 

petitions. The advantage to this change 

is that it ensures efficiency and ease in 

communication, quicker interaction 

between citizen petitioners and FDA, 

and easier access to FDA to seek input 

through the citizen petition process. 

The regulations in 21 CFR 12.22, 

issued under section 701(e)(2) of the 

FD&C Act (21 U.S.C. 371(e)(2)), set forth 

the instructions for filing objections and 

requests for a hearing on a regulation or 

order under § 12.20(d) (21 CFR 

12.20(d)). Objections and requests must 

be submitted within the time specified 

in § 12.20(e). Each objection, for which 

a hearing has been requested, must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under 21 CFR 12.24 and does 

not limit the evidence that may be 

presented if a hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

Section 12.45 (21 CFR 12.45) issued 

under section 701 of the FD&C Act (21 

U.S.C. 371), sets forth the format and 

procedures for any interested person to 

file a petition to participate in a formal 

evidentiary hearing, either personally or 

through a representative. Section 12.45 

requires that any person filing a notice 

of participation state their specific 

interest in the proceedings, including 

the specific issues of fact about which 

the person desires to be heard. This 

section also requires that the notice 

include a statement that the person will 

present testimony at the hearing and 

will comply with specific requirements 

in 21 CFR 12.85, or, in the case of a 

hearing before a Public Board of Inquiry, 

concerning disclosure of data and 

information by participants (21 CFR 

13.25). In accordance with § 12.45(e) the 

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73322 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

presiding officer may omit a 

participant’s appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the prehearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses, or other for-profit groups 

and institutions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.30—Citizen Petition ........................................................ 207 1 207 24 4,968 

10.33—Administrative reconsideration of action ................. 4 1 4 10 40 

10.35—Administrative Stay of Action .................................. 5 1 5 10 50 

10.85—Advisory Opinions ................................................... 4 1 4 16 64 

12.22—Filing Objections and Requests for a Hearing on a 

Regulation or Order .......................................................... 3 1 3 20 60 

12.45—Notice of Participation ............................................. 4 1 4 3 12 

Total .............................................................................. 5,194 

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

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28825 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1067] 

Patient Counseling Information 

Section of Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a 

guidance for industry entitled ‘‘Patient 

Counseling Information Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The recommendations in this 

guidance are intended to assist 

applicants in developing the ‘‘Patient 

Counseling Information’’ section of 

labeling and to help ensure that this 

section of labeling is clear, useful, 

informative, and to the extent possible, 

consistent in content and format. This 

guidance finalizes the draft guidance 

issued on September 18, 2013. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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, or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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 guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jonas Santiago, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6348, 

Silver Spring, MD 20993–0002, 301– 

796–5346; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Patient 

Counseling Information Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ This guidance is intended to 

assist applicants in developing the 

Patient Counseling Information section 

of labeling required under 21 CFR 

201.57(c)(18). Recommendations 

include the following: (1) How to decide 

what topics to include in the section, (2) 

how to present information within the 

section, and (3) how to format and 

organize section contents. 

This guidance is one of a series of 

guidances FDA is developing, or has 

developed, to assist applicants with the 

content and format of labeling for 

human prescription drug and biological 

products. In the Federal Register of 

January 24, 2006 (71 FR 3922), FDA 

published a final rule on labeling for 

human prescription drug and biological 

products. The final rule and additional 

guidances can be accessed at http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/

LawsActsandRules/ucm084159.htm. 

The labeling requirements and these 

guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

This guidance finalizes the draft 

guidance issued on September 18, 2013 

(78 FR 57394). FDA reviewed all 

received comments carefully during the 

finalization of the guidance. Other than 

clarifying edits, no changes of 

significance were made to the final 

version of the guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

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