Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79185 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials are part of 

the public record and are subject to 

public disclosure. Do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

CDC does not accept comment by email. 

Written Public Comment: Written 

comments must be received on or before 

December 14, 2020. Oral Public 

Comment: This meeting will include 

time for members of the public to make 

an oral comment. Oral public comment 

will occur before any scheduled votes 

including all votes relevant to the 

ACIP’s Affordable Care Act and 

Vaccines for Children Program roles. 

Priority will be given to individuals 

who submit a request to make an oral 

public comment before the meeting 

according to the procedures below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the December 13, 

2020 ACIP meeting must submit a 

request at http://www.cdc.gov/vaccines/ 

acip/meetings/ no later than 11:59 p.m., 

EST, December 11, 2020 according to 

the instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by 12:00 p.m., EST, December 12, 2020. 

To accommodate the significant interest 

in participation in the oral public 

comment session of ACIP meetings, 

each speaker will be limited to 3 

minutes, and each speaker may only 

speak once per meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, 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. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–27133 Filed 12–7–20; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No. 0970–0234] 

Proposed Information Collection 

Activity; Social Services Block Grant 

(SSBG) Post-Expenditure Report, PreExpenditure Report, and Intended Use 

Plan 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, HHS. 

ACTION: Request for Public Comment. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting a revision to the Social 

Services Block Grant (SSBG) PostExpenditure Report, Pre-Expenditure 

Report, and Intended Use Plan (OMB 

#0970–0234), previously titled, ‘‘Social 

Services Block Grant (SSBG) PostExpenditure Report’’). ACF is proposing 

to expand the information collection to 

include the collection of states’ 

Intended Use Plans and retitle the 

information collection to clarify the role 

of the Pre-Expenditure Report. 

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, 

ACF 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 emailing infocollection@

acf.hhs.gov. Alternatively, copies can 

also be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation (OPRE), 330 C Street 

SW, Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: On an annual basis, 

states and territories are required to 

submit the following reports: (1) An 

Intended Use Plan that provides data 

and narrative descriptions related to the 

state’s SSBG program. The Intended Use 

Plan includes details about the delivery 

of SSBG services and the state agency 

administering the SSBG Program. ACF 

is proposing to expand the currently 

approved information collection to 

include collection of states’ Intended 

Use Plans. Grantees are required to 

submit their Intended Use Plans no less 

than 30 days prior to the start of the 

budget period covered by the report. (2) 

A Pre-Expenditure Report that 

demonstrates the state’s anticipated 

allocation of SSBG funding among the 

29 pre-defined SSBG service categories. 

Historically, states have submitted this 

report using the Post-Expenditure 

Report Form, and the associated burden 

is included in the currently approved 

information collection. Grantees are 

required to submit their PreExpenditure Report no less than 30 days 

prior to the start of the budget period 

covered by the report. (3) A PostExpenditure Report that details the 

state’s actual use of SSBG funding 

among each of the 29 service categories. 

Grantees are required to submit their 

Post-Expenditure Report within 6 

months of the end of the period covered 

by the report. 

Respondents: Agencies that 

administer the SSBG at the state or 

territory level, including the 50 states; 

District of Columbia; Puerto Rico; and 

the territories of American Samoa, 

Guam, the Virgin Islands, and the 

Commonwealth of Northern Mariana 

Islands. 

Annual Burden Estimates 

This request is specific to the 

Intended Use Plan. Currently approved 

materials and associated burden can be 

found at: https://www.reginfo.gov/ 

public/do/PRAViewICR?ref_nbr=

202011-0970-006. 

Instrument Annual number 

of respondents 

Annual number 

of responses 

per respondent 

Average burden 

hours per 

response 

Total/annual 

burden hours 

Intended Use Plan ................................................................................... 56 1 40 2,240 


jbell on DSKJLSW7X2PROD with NOTICES
79186 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

Estimated Total Annual Burden 

Hours: 2,240. 

Comments: 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: 42 U.S.C. 1397 through 1397e. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–27015 Filed 12–8–20; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 pertaining to Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 8, 2021. 

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 February 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 8, 2021. 

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– 

2014–N–1076 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice.’’ 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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. 3501–3521), Federal 


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