26768 Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices 

If an applicant does not have a PSUR 

waiver in place for an approved 

application, the applicant may submit a 

waiver request under § 314.90(a) or 

§ 600.90(a) to submit a PBRER instead of 

the PADER/PAER. The applicant should 

submit a request to FDA for each 

approved application for which a 

waiver is requested, and a single waiver 

request letter can include multiple 

applications. Waiver requests should be 

submitted to each of the application(s) 

in the request, and may be submitted 

electronically or by mail as described in 

the April 8, 2013, draft guidance. Each 

PBRER waiver request should include 

the following information: 

1. The product name(s) and 

application number(s); 

2. A brief description of the 

justification for the request; 

3. The U.S. approval date for the 

product(s) and current reporting interval 

used; 

4. The reporting interval of the last 

PADER/PAER submitted for the 

product(s); 

5. The data lock point that will be 

used for each PBRER. If a data lock 

point other than one aligned to the U.S. 

approval date is proposed, the applicant 

should describe how he/she will ensure 

that there are no gaps in reporting 

intervals (e.g., by submitting 

overlapping reports; submitting a onetime PADER/PAER to cover the gap 

period; or, if the gap is less than 2 

months, extending the reporting interval 

of the final PADER/PAER to close the 

gap). 

6. The frequency for submitting the 

PBRER, as described in section IV.C of 

the April 8, 2013, draft guidance. 

7. The email address and telephone 

number for the individual who can 

provide additional information 

regarding the waiver request. 

As explained earlier, existing 

regulations at §§ 314.90(a) or 600.90(a) 

permit applicants to request waivers of 

any postmarketing safety reporting 

requirement, and the information 

collections associated with such waiver 

requests generally are approved under 

OMB control numbers 0910–0001and 

0910–0308. FDA believes that the 

information submitted under numbers 1 

to 4 and number 7 in the list in the 

previous paragraph is information that 

is typical of any waiver request 

regarding postmarketing safety reporting 

and is accounted for in the existing 

approved collections of information for 

waiver requests and reports. Concerning 

numbers 5 and 6, FDA expects 

approximately 67 waiver requests to 

include the additional information for 

using a different data lock point and/or 

for using a different reporting frequency 

when submitting a PBRER. FDA expects 

approximately 29 applicants to make 

these submissions, and we estimate that 

the time for submitting the additional 

information described in the previous 

paragraph would be on average 

approximately 2 hours for each waiver 

request. 

In the Federal Register of December 

10, 2013 (78 FR 74151), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the additional burden 

of this collection of information as 

follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Additional information and/or notifications for using 

a different data lock point and/or a different 

reporting frequency 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Applicants that have a PSUR waiver for an approved application ............................................................................ 55 3.4 187 1 187 

Applicants that do not have a PSUR waiver for an approved application ............................................................ 29 2.3 67 2 134 

Total .............................................................................. ........................ ........................ ........................ ........................ 321 

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

Dated: May 5, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–10658 Filed 5–8–14; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Organ 

Transplantation; Cancellation of 

Meeting 

Name: Advisory Committee on Organ 

Transplantation. 

Dates and Times: May 15, 2014, 10:00 

a.m. to 4:00 p.m., Eastern Time. 

Status: The meeting of the Advisory 

Committee on Organ Transplantation 

scheduled for May 15, 2014, is 

cancelled. This cancellation applies to 

all sessions of the meeting. The meeting 

was announced in the Federal Register 

on April 22, 2014 (79 FR 22507). 

For Further Information Contact: 

Patricia Stroup, MBA, MPA, Office of 

the Associate Administrator, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Room 17W43, Rockville, 

Maryland 20857; telephone (301) 443– 

1127. 

Dated: May 5, 2014. 

Bahar Niakan, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2014–10739 Filed 5–8–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2014–0022] 

Privacy Act of 1974; Computer 

Matching Program 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice. 

OVERVIEW INFORMATION: Privacy Act of 

1974; Computer Matching Program 

between the Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services and the 

Massachusetts Division of 

Unemployment Assistance. 

SUMMARY: This document provides 

notice of the existence of a computer 

matching program between the 

Department of Homeland Security, U.S. 


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Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices 26769 

Citizenship and Immigration Services 

and the Massachusetts Division of 

Unemployment Assistance, titled 

‘‘Verification Division DHS–USCIS/

MA–DUA.’’ 

SUPPLEMENTARY INFORMATION: The 

Department of Homeland Security, U.S. 

Citizenship and Immigration Services 

provides this notice in accordance with 

The Privacy Act of 1974 (5 § U.S.C. 

552a), as amended by the Computer 

Matching and Privacy Protection Act of 

1988 (Pub. L. 100–503) and the 

Computer Matching and Privacy 

Protection Amendments of 1990 (Pub. L. 

101–508) (Privacy Act); Office of 

Management and Budget (OMB) Final 

Guidance Interpreting the Provisions of 

Public Law 100–503, the Computer 

Matching and Privacy Protection Act of 

1988, 54 FR 25818 (June 19, 1989); and 

OMB Circular A–130, Appendix I, 65 FR 

77677 (December 12, 2000). 

Participating Agencies: The 

Department of Homeland Security, U.S. 

Citizenship and Immigration Services 

(DHS–USCIS) is the source agency and 

the Massachusetts Division of 

Unemployment Assistance (MA–DUA) 

is the recipient agency. 

Purpose of the Match: This Computer 

Matching agreement allows DHS–USCIS 

to provide MA–DUA with electronic 

access to immigration status information 

contained within the DHS–USCIS 

Verification Information System (VIS). 

The immigration status information will 

enable MA–DUA to determine whether 

an applicant is eligible for benefits 

under the Unemployment 

Compensation (UC) program 

administered by MA–DUA. 

Authority for Conducting the 

Matching Program: Section 121 of the 

Immigration Reform and Control Act 

(IRCA) of 1986, Public Law 99–603, as 

amended by the Personal Responsibility 

and Work Opportunity Reconciliation 

Act of 1996 (PRWORA), requires DHS to 

establish a system for the verification of 

immigration status of alien applicants 

for, or recipients of, certain types of 

benefits and to make this system 

available to state agencies that 

administer such benefits. Section 121(c) 

of IRCA amends Section 1137 of the 

Social Security Act and certain other 

sections of law that pertain to Federal 

entitlement benefit programs to require 

state agencies administering these 

programs to use the DHS–USCIS 

verification system to make eligibility 

determinations in order to prevent the 

issuance of benefits to alien and 

naturalized/derived United States 

citizen applicants who are not entitled 

to program benefits because of their 

immigration status. The VIS database is 

the DHS–USCIS system established and 

made available to MA–DUA and other 

covered agencies for use in making 

these eligibility determinations. 

MA–DUA seeks access to the 

information contained in DHS–USCIS 

VIS database for the purpose of 

confirming the immigration status of 

alien applicants for, or recipients of, the 

benefits it administers, in order to 

discharge its obligation to conduct such 

verifications pursuant to Section 1137 of 

the Social Security Act, 42 U.S.C. 

1320b-7, and to Mass. Gen. Laws ch. 

151A, § 25(h). 

Categories of Records and Individuals 

Covered: DHS/USCIS will provide the 

following to MA–DUA: Records in the 

DHS–USCIS VIS database containing 

information related to the status of 

aliens and other persons on whom 

DHS–USCIS has a record as an 

applicant, petitioner, or beneficiary. See 

DHS/USCIS–004 Systematic Alien 

Verification for Entitlements Program 

System of Records Notice, 77 FR 47415 

(August 8, 2012). 

MA–DUA will provide the following 

to DHS–USCIS: MA–DUA records 

pertaining to alien and naturalized/

derived United States citizen applicants 

for, or recipients of entitlement benefit 

programs administered by the State. 

MA–DUA will match the following 

records with DHS–USCIS records: 

• Alien Registration Number 

• 1–94 Number 

• Last Name 

• First Name 

• Middle Name 

• Date of Birth 

• Nationality 

• Social Security Number (SSN) 

DHS–USCIS will match the following 

records with MA–DUA records: 

• Alien Registration Number 

• Last Name 

• First Name 

• Middle Name 

• Date of Birth 

• Country of Birth (not nationality) 

• SSN (if available) 

• Date of Entry 

• Immigration Status Data 

• Sponsorship Information (sponsor’s 

full name, SSN, and address) 

Inclusive Dates of the Matching 

Program: The inclusive dates of the 

matching program are from June 14, 

2014, and continuing for 18 months 

through December 13, 2015. The 

matching program may be extended for 

up to an additional 12 months 

thereafter, if certain conditions are met. 

Address for Receipt of Public 

Comments or Inquires: Individuals 

wishing to comment on this matching 

program or obtain additional 

information about the program, 

including requesting a copy of the 

computer matching agreement between 

DHS–USCIS and MA–DUA, may 

contact: 

For general questions please contact: 

Donald K. Hawkins, 202–272–8030, 

Privacy Officer, U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security, 20 Massachusetts 

Avenue NW., Washington, DC 20529. 

For privacy questions please contact: 

Karen L. Neuman (202–343–1717), 

Chief Privacy Officer, Privacy Office, 

Department of Homeland Security, 

Washington, DC 20528. 

Dated: April 29, 2014. 

Karen L. Neuman 

Chief Privacy Officer, Department of 

Homeland Security. 

[FR Doc. 2014–10594 Filed 5–8–14; 8:45 am] 

BILLING CODE 9110–9L–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2014–0025] 

Privacy Act of 1974; Computer 

Matching Program 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice. 

Overview Information: Privacy Act of 

1974; Computer Matching Program 

between the Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services and the Texas 

Workforce Commission. 

SUMMARY: This document provides 

notice of the existence of a computer 

matching program between the 

Department of Homeland Security, U.S. 

Citizenship and Immigration Services 

and the Texas Workforce Commission, 

titled ‘‘Verification Division DHS– 

USCIS/TWC.’’ 

SUPPLEMENTARY INFORMATION: The 

Department of Homeland Security, U.S. 

Citizenship and Immigration Services 

provides this notice in accordance with 

the Privacy Act of 1974 (5 U.S.C. 552a), 

as amended by the Computer Matching 

and Privacy Protection Act of 1988 (Pub. 

L. 100–503) and the Computer Matching 

and Privacy Protection Amendments of 

1990 (Pub. L. 101–508) (Privacy Act); 

Office of Management and Budget 

(OMB) Final Guidance Interpreting the 

Provisions of Public Law 100–503, the 

Computer Matching and Privacy 

Protection Act of 1988, 54 FR 25818 

(June 19, 1989); and OMB Circular A– 


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