35488 Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 

C. Notice Upon Completion of 

Evaluation 

Upon completion of our evaluation, 

including evaluation of public 

comments received as a result of this 

notice, we will publish a final notice in 

the Federal Register announcing the 

result of our evaluation. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

IV. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Dated: July 20, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–15951 Filed 7–23–18; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: National Youth in Transition 

Database (NYTD) and Youth Outcomes 

Survey. 

OMB No.: 0970–0340. 

Description: The John H. Chafee 

Foster Care Program for Successful 

Transition to Adulthood (42 U.S.C. 677, 

as amended by Pub. L. 115–123, the 

Family First Prevention Services Act 

within Division E, Title VII of the 

Bipartisan Budget Act of 2018) requires 

State child welfare agencies to collect 

and report to the Administration for 

Children and Families (ACF) data on the 

characteristics of youth receiving 

independent living services and 

information regarding their outcomes. 

The regulation implementing the 

National Youth in Transition Database 

(NYTD), listed in 45 CFR 1356.80, 

contains standard data collection and 

reporting requirements for States to 

meet the law’s requirements. ACF uses 

the information collected under the 

regulation to track independent living 

services, assess the collective outcomes 

of youth, and assess performance with 

regard to those outcomes, consistent 

with the law’s mandate. 

Respondents: State agencies 

(including agencies of the District of 

Columbia, Puerto Rico and the U.S. 

Virgin Islands) that administer the John 

H. Chafee Foster Care Program for 

Successful Transition to Adulthood. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

Youth Outcome Survey ................................................................................... 21,064 1 0.50 10,529 

Data File .......................................................................................................... 53 2 1,849 195,994 

Estimated Total Annual Burden 

Hours: 206,253. 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35), the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

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: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

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. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15989 Filed 7–25–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1011] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Permanent 

Discontinuation or Interruption in 

Manufacturing of Certain Drug and 

Biological Products 

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 August 27, 

2018. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 35489 

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 0910–0759. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Permanent Discontinuation or 

Interruption in Manufacturing of 

Certain Drug and Biological Products— 

21 CFR 310.306, 314.81(b)(3)(iii), and 

600.82 

OMB Control Number 0910–0759— 

Extension 

Sections 310.306, 314.81(b)(3)(iii), 

and 600.82 (21 CFR 310.306, 

314.81(b)(3)(iii), and 600.82) were 

modified to implement sections 506C 

and 506E of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 356c and 356e) 

as amended by the Food and Drug 

Administration Safety and Innovation 

Act. Under these sections, applicants 

with an approved new drug application 

(NDA) or abbreviated new drug 

application (ANDA) for a covered drug 

product, manufacturers of a covered 

drug product marketed without an 

approved application, and applicants 

with an approved biologics license 

application (BLA) for a covered 

biological product (including certain 

applications of blood or blood 

components) must notify FDA in 

writing of a permanent discontinuance 

of the manufacture of the drug or 

biological product, or an interruption in 

manufacturing of the drug or biological 

product, that is likely to lead to a 

meaningful disruption in the applicant’s 

supply (or a significant disruption for 

blood or blood components) of that 

product. The notification is required if 

the drug or biological product is life 

supporting, life sustaining, or intended 

for use in the prevention or treatment of 

a debilitating disease or condition, 

including use in emergency medical 

care or during surgery, and if the drug 

or biological product is not a 

radiopharmaceutical drug product. 

The regulations also require that the 

notification include the following 

information: (1) The name of the drug or 

biological product subject to the 

notification, including the National 

Drug Code Directory (NDC) (or, for a 

biological product that does not have an 

NDC, an alternative standard for 

identification and labeling that has been 

recognized as acceptable by the Center 

Director); (2) the name of each applicant 

of the drug or biological product; (3) 

whether the notification relates to a 

permanent discontinuance of the drug 

or biological product or an interruption 

in manufacturing of the product; (4) a 

description of the reason for the 

permanent discontinuance or 

interruption in manufacturing; and (5) 

the estimated duration of the 

interruption in manufacturing. The 

notification must be submitted to FDA 

electronically at least 6 months prior to 

the date of the permanent 

discontinuance or interruption in 

manufacturing. If 6 months’ advance 

notice is not possible because the 

permanent discontinuance or 

interruption in manufacturing was 

unanticipated 6 months in advance, the 

applicant must notify FDA as soon as 

practicable, but in no case later than 5 

business days after the permanent 

discontinuance or interruption in 

manufacturing occurs. 

If an applicant fails to submit the 

required notification, FDA will issue a 

letter informing the applicant or 

manufacturer of its noncompliance. The 

applicant must submit to FDA, not later 

than 30 calendar days after FDA issues 

the letter, a written response setting 

forth the basis for noncompliance and 

providing the required notification. 

Description of Respondents: 

Applicants of prescription drugs and 

biological products subject to an 

approved NDA, ANDA, or BLA, and 

manufacturers of prescription drug 

products marketed without an approved 

ANDA or NDA, if the product is life 

supporting, life sustaining, or intended 

for use in the prevention or treatment of 

a debilitating disease or condition, 

including use in emergency medical 

care or during surgery, or is not a 

radiopharmaceutical product. If the BLA 

applicant is a manufacturer of blood or 

blood components, it is only subject to 

these regulations if it manufactures a 

significant percentage of the nation’s 

blood supply. 

Burden Estimates: Based on the 

number of drug and biological product 

shortage related notifications we have 

seen in the past 12 months, we estimate 

that annually a total of approximately 

75 respondents (‘‘No. of Respondents’’ 

in table 1) will notify us of a permanent 

discontinuance of the manufacture of a 

drug or biological product or an 

interruption in manufacturing of a drug 

or biological product that is likely to 

lead to a meaningful disruption in the 

respondent’s supply of that product. We 

estimate that these respondents will 

submit annually a total of 

approximately 352.5 notifications as 

required under §§ 310.306, 

314.81(b)(3)(iii), and 600.82. We 

estimate 4.7 notifications per 

respondent, because a respondent may 

experience multiple discontinuances or 

interruptions in manufacturing in a year 

that requires notification (‘‘No. of 

Responses per Respondent’’ in table 1). 

We also estimate that preparing and 

submitting these notifications to FDA 

will take approximately 2 hours per 

respondent (‘‘Average Burden per 

Response’’ in table 1). 

In the Federal Register of April 13, 

2018, (83 FR 16108), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Notifications required under §§ 310.306 (unapproved 

drugs), 314.81(b)(3)(iii) (products approved under an 

NDA or ANDA), and 600.82 (products approved under a 

BLA) .................................................................................. 75 4.7 352.5 2 705 

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


sradovich on DSK3GMQ082PROD with NOTICES
35490 Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 

The estimated burden for this 

information collection has changed 

since the previous OMB approval. The 

current burden is based on the number 

of actual new notifications received 

including notifications that were 

counted previously under the OMB 

approval for the interim final rule 

entitled ‘‘Permanent Discontinuance or 

Interruption in Manufacturing of Certain 

Drug or Biological Products’’ (80 FR 

38915, July 8, 2015) (OMB control 

number 0910–0699). 

Dated: July 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15948 Filed 7–25–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal for the Advisory 

Commission on Childhood Vaccines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: HHS is hereby giving notice 

that the Advisory Commission on 

Childhood Vaccines (ACCV) has been 

rechartered. The effective date of the 

renewed charter is July 20, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Narayan Nair, MD, MPH, Executive 

Secretary, Advisory Commission on 

Childhood Vaccines, Health Resources 

and Services Administration, 

Department of Health and Human 

Services, Room 08N146B, 5600 Fishers 

Lane, Rockville, MD 20857; phone: 

(301) 443–6593; fax: (301) 443–8196; 

email: nnair@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The ACCV 

was established by section 2119 of the 

Public Health Service Act (the Act) (42 

U.S.C. 300aa–19), as enacted by Public 

Law (Pub. L.) 99–660, and as 

subsequently amended, and advises the 

Secretary of Health and Human Services 

(the Secretary) on issues related to 

implementation of the National Vaccine 

Injury Compensation Program (VICP). 

Other activities of the ACCV include: 

Recommending changes in the Vaccine 

Injury Table at its own initiative or as 

the result of the filing of a petition; 

advising the Secretary in implementing 

section 2127 of the Act regarding the 

need for childhood vaccination 

products that result in fewer or no 

significant adverse reactions; surveying 

federal, state, and local programs and 

activities related to gathering 

information on injuries associated with 

the administration of childhood 

vaccines, including the adverse reaction 

reporting requirements of section 

2125(b) of the Act; advising the 

Secretary on the methods of obtaining, 

compiling, publishing, and using 

credible data related to the frequency 

and severity of adverse reactions 

associated with childhood vaccines; 

consulting on the development or 

revision of Vaccine Information 

Statements; and recommending to the 

Director of the National Vaccine 

Program research related to vaccine 

injuries which should be conducted to 

carry out the VICP. 

The charter renewal for ACCV was 

approved on July 20, 2018, which will 

also stand as the filing date. Renewal of 

the ACCV charter gives authorization for 

the Commission to operate until July 20, 

2020. 

A copy of the ACCV charter is 

available on the VICP website at: 

https://www.hrsa.gov/advisorycommittees/vaccines/index.html. A 

copy of the charter also can be obtained 

by accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

website address for the FACA database 

is http://www.facadatabase.gov/. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–15994 Filed 7–25–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Resource-Related 

Research Projects (R24). 

Date: August 23, 2018. 

Time: 2:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Dharmendar Rathore, 

Ph.D., Senior Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3G30, National 

Institutes of Health/NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

240–669–5058, rathored@mail.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Implementation Cooperative Agreement 

(U01). 

Date: August 24, 2018. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Chelsea D. Boyd, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, MSC 9823, Rockville, MD 

20852–9834, 240–669–2081, chelsea.boyd@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: July 20, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–15953 Filed 7–25–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5976–N–07] 

Housing Opportunity Through 

Modernization Act of 2016: Final 

Implementation of Public Housing 

Income Limit 

AGENCY: Office of the Assistant 

Secretary for Public and Indian 

Housing, HUD. 

ACTION: Notice. 

SUMMARY: The Housing Opportunity 

Through Modernization Act of 2016 

(HOTMA) was signed into law on July 

29, 2016. One of the statutory 

amendments made by HOTMA adds an 

income limit to the Public Housing 

program. This notice informs the public 

of how HUD is setting that income limit 

and makes the income limit effective, 

while providing information to public 


sradovich on DSK3GMQ082PROD with NOTICES