Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51277 

groups, online surveys, direct 

observation, and document review. 

Respondents: Up to 18 early 

childhood centers will be invited to 

express interest in participating in the 

BSC. Up to 8 centers will be selected to 

participate in the BSC and feasibility 

study. Core BSC Teams consisting of up 

to 6 individuals (e.g., directors, lead 

teachers, assistant teachers, teacher 

aides, parents, curriculum specialists, 

etc.) each from four Early Head Start or 

Head Start programs and four child care 

programs in a selected geographic 

location (for a total of 48 individuals); 

and up to 24 additional teachers or 

program staff at the same centers who 

are not part of the Core BSC Team. 

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 

BSC Selection Questionnaire ............................................ 18 9 1 1 9 

Pre-Work Assignment: Team Building Activities ............... 48 24 1 1 24 

Pre-Work Assignment: Data Collection Planning Worksheet ............................................................................... 16 8 1 2 16 

Plan, Do, Study, Act Planning Form & Tracker ................. 48 24 48 .25 288 

Discussion Forum Prompts ................................................ 48 24 48 .25 288 

Learning Session Day 1 Evaluation .................................. 48 24 4 .17 16 

Learning Session Overall Evaluation ................................. 48 24 4 .25 24 

Action Planning Form ........................................................ 48 24 4 .25 24 

Teaching Pyramid Observation Tool (TPOT)/Teaching 

Pyramid Infant-Toddler Observation Scale (TPITOS) ... 28 14 2 .33 9 

Early Childhood Work Environment Survey (ECWES) ..... 72 36 2 .25 18 

Pre/Post Survey ................................................................. 72 36 2 .68 49 

Self-report of BSC Activities .............................................. 72 36 1 .17 6 

Core BSC Team Focus Group Topic Guide ..................... 48 24 1 1 .25 30 

Estimated Total Annual Burden 

Hours: 801. 

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, 330 

C Street SW., Washington, DC 20201, 

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. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2017–23970 Filed 11–2–17; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1147] 

Controlled Correspondence Related to 

Generic Drug Development; Draft 

Guidance 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 a draft 

guidance for industry entitled 

‘‘Controlled Correspondence Related to 

Generic Drug Development.’’ This 

guidance provides information 

regarding the process by which generic 

drug manufacturers and related industry 

can submit controlled correspondence 

to FDA requesting information related to 

generic drug development and the 

Agency’s process for providing 

communications related to such 

correspondence. This guidance also 

describes the process by which generic 

drug manufacturers and related industry 

can submit requests to clarify 

ambiguities in FDA’ controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. This draft guidance 

revises the guidance for industry 

‘‘Controlled Correspondence Related to 

Generic Drug Development’’ issued in 

September 2015. 

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 January 2, 

2018. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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 


ethrower on DSK3G9T082PROD with NOTICES
51278 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 

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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2014–D–1147 for ‘‘Controlled 

Correspondence Related to Generic Drug 

Development; Draft Guidance for 

Industry; Availability.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov

/fdsys/pkg/FR-2015-09-18/pdf/2015-233

89.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 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: Lisa 

Bercu, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1611, Silver Spring, 

MD 20993–0002, 240–402–6902. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Controlled Correspondence Related to 

Generic Drug Development.’’ This 

guidance provides information 

regarding the process by which generic 

drug manufacturers and related industry 

can submit to FDA controlled 

correspondence requesting information 

related to generic drug development and 

the Agency’s process for providing 

communications related to such 

correspondence. This guidance also 

describes the process by which generic 

drug manufacturers and related industry 

can submit requests to clarify 

ambiguities in FDA’s controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. In accordance with the 

Generic Drug User Fee Amendments 

(GDUFA) Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2018–2022 (GDUFA II Goals 

Letter or GDUFA II Commitment Letter), 

FDA agreed to certain review goals and 

procedures for the review of controlled 

correspondence received both before, 

and on or after October 1, 2017. 

The GDUFA II Commitment Letter 

defines standard controlled 

correspondence and complex controlled 

correspondence, and the draft guidance 

provides additional details and 

recommendations concerning what 

inquiries FDA considers controlled 

correspondence for the purposes of 

meeting the Agency’s GDUFA II 

commitment. In addition, this guidance 

provides details and recommendations 

concerning what information requestors 

should include in a controlled 

correspondence to facilitate FDA’s 

consideration of and response to a 

controlled correspondence and what 

information FDA will provide in its 

communications to requestors that have 

submitted controlled correspondence. 

The GDUFA II Commitment Letter also 

states that FDA will review and respond 

to requests to clarify ambiguities in the 

controlled correspondence response, 

and the guidance provides information 

on how requestors may submit these 

requests and the Agency’s process for 

responding to them. 

This guidance revises the guidance for 

industry ‘‘Controlled Correspondence 

Related to Generic Drug Development’’ 

issued in September 2015 available at: 

https://www.fda.gov/downloads/drugs/ 

guidances/ucm411478.pdf. When 

finalized, this guidance will replace the 

September 2015 final guidance. Changes 

from the 2015 version include: 

Recommendations on requests 

concerning postapproval submission 

requirements and complex controlled 

correspondence, and information on 

how requestors can submit requests to 

clarify ambiguities in FDA’s controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on controlled correspondence related to 

generic drug development. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The title and 

description of the information collection 

are given under this section, with an 

estimate of the reporting burden. 

Included in the estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing the collection 

of information. 


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Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51279 

We invite 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. 

Title: Controlled Correspondence 

Related to Generic Drug Development— 

OMB Control Number 0910–0797— 

Revision. 

Description: FDA has agreed to 

specific program enhancements and 

performance goals specified in the 

GDUFA II Commitment Letter. One of 

the performance goals applies to 

controlled correspondence related to 

generic drug development. The GDUFA 

II Commitment Letter includes details 

on FDA’s commitment to respond to 

questions submitted as controlled 

correspondence within certain time 

frames. To facilitate FDA’s prompt 

consideration of the controlled 

correspondence and to assist in meeting 

the prescribed time frames, FDA 

recommends including the following 

information in the inquiry: (1) Name, 

title, address, phone number, and entity 

of the person submitting the inquiry; (2) 

a letter of authorization, if applicable; 

(3) the FDA-assigned control number 

and submission date of any previous, 

related controlled correspondence that 

was accepted for substantial review and 

response, if any, as well as a copy of 

that previous controlled correspondence 

and FDA’s response, if any; (4) the 

relevant reference listed drug(s), as 

applicable, including the application 

number, proprietary (brand) name, 

manufacturer, active ingredient, dosage 

form, and strength(s); (5) a statement 

that the controlled correspondence is 

related to a potential abbreviated new 

drug application (ANDA) submission to 

the Office of Generic Drugs, and the 

ANDA number, if applicable; (6) a 

concise statement of the inquiry; (7) a 

recommendation of the appropriate FDA 

review discipline; and (8) relevant prior 

research and supporting materials. 

The GDUFA II Commitment Letter 

also includes details on FDA’s 

commitment to respond to requests to 

clarify ambiguities in FDA’s controlled 

correspondence response within certain 

time frames. To facilitate FDA’s prompt 

consideration of the request, and to 

assist in meeting the prescribed time 

frames, FDA recommends including the 

following information in the inquiry: (1) 

Name, title, address, phone number, and 

entity of the person submitting the 

inquiry; (2) a letter of authorization, if 

applicable; (3) the FDA-assigned control 

number, submission date of the 

controlled correspondence on which the 

requestor is seeking clarification, a copy 

of that previous controlled 

correspondence, and FDA’s response to 

the controlled correspondence; and (4) 

the clarifying questions and the 

corresponding section(s) of FDA’s 

controlled correspondence response on 

which the requestor is seeking 

clarification. 

The following information is based on 

inquiries considered controlled 

correspondence and submitted to FDA 

for fiscal years 2014, 2015, and 2016. 

FDA estimates approximately 390 

generic drug manufacturers and related 

industry (e.g., contract research 

organizations conducting bioanalytical 

or bioequivalence clinical trials) or their 

representatives would each submit an 

average of 3.8 inquiries annually for a 

total of 1,496 inquiries [1,496 ÷ 390 = 

3.8]. Information submitted with each 

inquiry varies widely in content, 

depending on the complexity of the 

request. Inquiries that are defined as 

controlled correspondence may range 

from a simple inquiry on generic drug 

labeling to a more complex inquiry for 

a formulation assessment for a specific 

proposed generic drug product. As a 

result, these inquiries can vary between 

1 to 10 burden hours, respectively. 

Because the content of inquiries 

considered controlled correspondence is 

widely varied, we are providing an 

average burden hour for each inquiry. 

We estimate that it will take an average 

of 5 hours per inquiry for industry to 

gather necessary information, prepare 

the request, and submit the request to 

FDA. As a result, we estimate that it will 

take an average of 7,480 total hours 

annually for industry to prepare and 

submit inquiries considered controlled 

correspondence. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Submission of controlled correspondence Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Generic drug manufacturers, related industry, and representatives ...................................................................... 390 3.8 1,496 5 7,480 

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

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https:// 

www.regulations.gov. 

Dated: October 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23947 Filed 11–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0510] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (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 


ethrower on DSK3G9T082PROD with NOTICES