30736 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total/annual 

number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Annual 

burden 

hours 

Needs Assessment Survey ............................................................................. 216 2 0.25 108 

Estimated Total Annual Burden 

Hours: 108. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of Section 3506(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. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded 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. Email 

address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 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. 

Authority: Sec. 413, Pub. L. 115–31. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–14037 Filed 6–28–18; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2029] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 July 30, 

2018. 

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 0910–0191. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Administrative Practices and 

Procedures; Formal Evidentiary Public 

Hearing 

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), 

a citizen petition requesting the 

Commissioner of Food and Drugs (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 (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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30737 

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, 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, an advisory 

opinion from the Commissioner 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. 

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 https://

www.regulations.gov, the U.S. 

Government’s consolidated docket 

website for Federal Agencies, for the 

initial electronic submission of all 

citizen petitions. The advantage to this 

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, 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, 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 

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. 

In the Federal Register of February 

22, 2018 (83 FR 7742), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

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 ......................................................... 220 1 220 24 5,280 

10.33—Administrative reconsideration of action ................. 6 1 6 10 60 

10.35—Administrative stay of action ................................... 6 1 5 10 50 

10.85—Requests for Advisory opinions .............................. 4 1 4 16 64 

12.22—Filing objections and requests for a hearing on a 

regulation or order ............................................................ 5 1 5 20 100 

12.45—Notice of participation .............................................. 5 1 5 3 15 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,569 

1.There 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. The increase in burden 

hours is due to an increase in the 

number of respondents under several 

provisions. 


sradovich on DSK3GMQ082PROD with NOTICES
30738 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14058 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0268] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Labeling of Certain 

Beers Subject to the Labeling 

Jurisdiction of the Food and Drug 

Administration 

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 

collection provisions of the 

recommended labeling of certain beers 

subject to our labeling jurisdiction. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 28, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 28, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 28, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 

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– 

2009–D–0268 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Labeling 

of Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug 

Administration.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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- 

23389.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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 


sradovich on DSK3GMQ082PROD with NOTICES