40520 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 

795–7732 or kristen.hudgins@

acl.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, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following collection 

of information, ACL invites comments 

on our burden estimates or any other 

aspect of this collection of information, 

including: 

(1) Whether the proposed collection 

of information is necessary for the 

proper performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) The accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(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. 

The data collection materials for the 

annual performance data for the 

Administration for Community Living’s 

American Indian, Alaskan Natives and 

Native Hawaiian Programs (OAA Title 

VI) is a revision of a currently approved 

annual program performance data 

collection (OMB# 0985–0059). These 

data collection materials have been 

updated to better align with comparable 

data collected for ACL’s other 

nutritional, supportive, and caregiving 

grants. Proposed changes include 

adding data components and updating 

others for more accurate reporting of 

persons served and activities provided 

through the Title VI-funded programs. 

The revised data collection will provide 

data necessary to determine the 

effectiveness of the program. Some 

examples of these changes are updating 

definitions in Title VI to be more in line 

with Title III, asking for unduplicated 

numbers of people served for different 

services and the number of hours spent 

providing said services. Additionally, 

the caregiver portion of the PPR has 

been updated to collect more 

information around types of caregivers 

served and unduplicated numbers of 

caregivers. Another element added has 

to do with information on expenditures. 

This data collection will also support 

ACL in tracking performance outcomes 

and efficiency measures with respect to 

the annual and long-term performance 

targets established in compliance with 

the Government Performance Results 

Modernization Act (GPRAMA). 

The proposed data collection tools 

may be found on the ACL website for 

review at https://www.acl.gov/aboutacl/public-input. 

Estimated Program Burden: Title VI 

funding is broken into three categories. 

Parts A and B are for nutritional and 

supportive programming, and ask for 

the same information. Part A is for 

American Indian and Alaska Native 

grantees, and Part B is for Native 

Hawaiian grantees. Part C is for 

caregiver programming. All Part C 

grantees must have Part A/B funding; 

but not all Part A/B grantees will have 

Part C programs. Therefore, there are 

270 unique respondents, but only 237 

will have to complete all portions of the 

PPR. ACL believes that the increase in 

burden hours is justified by the 

improved quality of the data and will 

ultimately improve the services 

provided to Native Elders. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

PPR Part A/B ................................................................................................... 270 1 1.83 494.1

PPR Part C ...................................................................................................... 237 1 1.66 393.4 

Total: ......................................................................................................... ........................ ........................ ........................ 887.5 

Dated: August 8, 2018. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2018–17576 Filed 8–14–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0915] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Nonprescription 

Human Drug Products Marketed 

Without an Approved Application 

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 collection of 

information entitled ‘‘Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Nonprescription 

Human Drug Products Marketed 

Without an Approved Application.’’ 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 40521 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 15, 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 October 15, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 15, 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– 

2011–N–0915 for ‘‘Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Nonprescription 

Human Drug Products Marketed 

Without an Approved Application.’’ 

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 

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. 

Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application; OMB Control 

Number 0910–0636—Extension 

This information collection supports 

Agency guidance directed to 

manufacturers, packers, and/or 

distributors whose names appear on the 

label of a nonprescription drug 

marketed in the United States under 

section 502(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 352(b)(1)). FDA is requesting 

public comment on estimates of annual 

submissions from these respondents, as 

required by the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Pub. L. 109–462) and 

described in the guidance. The guidance 

document discusses what should be 

included in a serious adverse drug event 

report submitted under section 760(b)(1) 


daltland on DSKBBV9HB2PROD with NOTICES
40522 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 

of the FD&C Act (21 U.S.C. 379aa(b)(1)), 

including followup reports under 

760(c)(2) of the FD&C Act (21 U.S.C. 

379aa(c)(2)), and how to submit these 

reports. The estimates for the annual 

reporting and recordkeeping burdens 

are based on FDA data on the number 

of adverse drug experience reports 

submitted for nonprescription drug 

products marketed without an approved 

application and on prior input from 

comments received from prior Federal 

Register publications. 

Based on FDA records, we received 

194,449 total annual responses from 

approximately 283 respondents for 

nonprescription drugs marketed without 

an approved application. We estimate 

that each submission will take 

approximately 6 hours to prepare and 

submit. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Reports of serious adverse drug events (21 U.S.C. 

379aa((b) and (c)) ............................................................ 283 687.099 194,449 6 1,166,694 

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

Section 760(e) of the FD&C Act (21 

U.S.C. 379aa(e)) also requires that 

responsible persons maintain records of 

nonprescription adverse event reports, 

whether or not the event is serious, for 

a period of 6 years. The guidance 

recommends that respondents maintain 

records of efforts to obtain the minimum 

data elements for a report of a serious 

adverse drug event and any followup 

reports. We estimate that there are 

approximately 265,700 records per year 

maintained by approximately 300 

respondents, and that it takes 

approximately 8 hours to maintain each 

record. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 300 885.6667 265,700 8 2,125,600 

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

Our estimated burden for the 

information collection reflects an 

overall increase. We attribute this 

adjustment to an increase in the number 

of submissions we received in the last 

few years. 

Dated: August 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17526 Filed 8–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2944] 

Pharmaceutical Science and Clinical 

Pharmacology Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pharmaceutical Science 

and Clinical Pharmacology Advisory 

Committee. The general function of the 

committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

September 20, 2018, from 8 a.m. to 5 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–2944. 

The docket will close on September 19, 

2018. Submit either electronic or 

written comments on this public 

meeting by September 19, 2018. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 19, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

September 19, 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. 

Comments received on or before 

September 5, 2018, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. 

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, 


daltland on DSKBBV9HB2PROD with NOTICES