83_FR_47803 83 FR 47620 - Privacy Act of 1974; Matching Program

83 FR 47620 - Privacy Act of 1974; Matching Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range47620-47622
FR Document2018-20510

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), ``Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.'' In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).

Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018)
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47620-47622]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Matching Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

[[Page 47621]]


ACTION: Notice of New Matching Program.

-----------------------------------------------------------------------

SUMMARY: In accordance with subsection (e)(12) of the Privacy Act of 
1974, as amended, the Department of Health and Human Services (HHS), 
Centers for Medicare & Medicaid Services (CMS) is providing notice of a 
new computer matching program between CMS and the Department of 
Homeland Security (DHS)/United States Citizenship and Immigration 
Services (USCIS), ``Verification of United States Citizenship and 
Immigration Status Data for Eligibility Determinations.'' In this 
matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, 
and naturalized or derived citizenship status information needed to 
make enrollment and exemption eligibility determinations as required by 
the Patient Protection and Affordable Care Act (ACA).

DATES: The deadline for comments on this notice is October 22, 2018. 
The re-established matching program will commence not sooner than 30 
days after publication of this notice, provided no comments are 
received that warrant a change to this notice. The matching program 
will be conducted for an initial term of 18 months (from approximately 
October 2018 to April 2020) and within 3 months of expiration may be 
renewed for one additional year if the parties make no change to the 
matching program and certify that the program has been conducted in 
compliance with the matching agreement.

ADDRESSES: Interested parties may submit comments on the new matching 
program to the CMS Privacy Officer by mail at: Division of Security, 
Privacy Policy & Governance, Information Security & Privacy Group, 
Office of Information Technology, Centers for Medicare & Medicaid 
Services, Location: N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-
1850, or walter.stone@cms.hhs.gov. Comments received will be available 
for review without redaction unless otherwise advised by the commenter 
at this location, by appointment, during regular business hours, Monday 
through Friday from 9:00 a.m. to 3:00 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions about the 
matching program, you may contact Jack Lavelle, Senior Advisor, 
Marketplace Eligibility and Enrollment Group, Centers for Consumer 
Information and Insurance Oversight, CMS, at (410) 786-0639, by email 
at Jack.Lavelle1@cms.hhs.gov, or by mail at 7501 Wisconsin Ave., 
Bethesda, MD 20814.

SUPPLEMENTARY INFORMATION: The Privacy Act of 1974, as amended (5 
U.S.C. 552a) provides certain protections for individuals applying for 
and receiving federal benefits. The law governs the use of computer 
matching by federal agencies when records in a system of records 
(meaning, federal agency records about individuals retrieved by name or 
other personal identifier) are matched with records of other federal or 
non-federal agencies. The Privacy Act requires agencies involved in a 
matching program to:
    1. Enter into a written agreement, which must be prepared in 
accordance with the Privacy Act, approved by the Data Integrity Board 
of each source and recipient federal agency, provided to Congress and 
the Office of Management and Budget (OMB), and made available to the 
public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).
    2. Notify the individuals whose information will be used in the 
matching program that the information they provide is subject to 
verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).
    3. Verify match findings before suspending, terminating, reducing, 
or making a final denial of an individual's benefits or payments or 
taking other adverse action against the individual, as required by 5 
U.S.C. 552a(p).
    4. Report the matching program to Congress and the OMB, in advance 
and annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and 
(u)(3)(D).
    5. Publish advance notice of the matching program in the Federal 
Register as required by 5 U.S.C. 552a(e)(12).
    This matching program meets these requirements.

Barbara Demopulos,
CMS Privacy Advisor, Division of Security, Privacy Policy and 
Governance, Information Security and Privacy Group, Office of 
Information Technology, Centers for Medicare & Medicaid Services.

PARTICIPATING AGENCIES:
    The Department of Health and Human Services (HHS), Centers for 
Medicare & Medicaid Services (CMS) is the recipient agency, and the 
Department of Homeland Security (DHS), United States Citizenship and 
Immigration Services (USCIS) is the source agency.

AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM:
    The statutory authority for the matching program is 42 U.S.C. 
18001.

PURPOSE(S):
    The matching program will provide CMS with USCIS data, including 
immigrant, nonimmigrant, and naturalized or derived citizenship status 
information from USCIS's SAVE program and VIS system. This data will 
indicate whether an applicant or enrollee is lawfully present, a 
qualified non-citizen, a naturalized or derived citizen, and whether 
the five-year waiting period for many non-citizens applies and has been 
met. CMS and state administering entities will use the data to 
determine the individual's eligibility for enrollment in a qualified 
health plan through a federally-facilitated exchange (FFE) and for 
insurance affordability programs and certificates of exemption, and to 
make eligibility redetermination and renewal decisions, including 
appeal determinations. USCIS will provide the data from USCIS's SAVE 
program and VIS system about individuals whose identifying information 
matches identifying information that CMS submits to USCIS. CMS will 
make the USCIS data available to requesting state administering 
entities through a data services hub (Hub).

CATEGORIES OF INDIVIDUALS:
    The individuals whose information will be used in the matching 
program are consumers who apply for any of the following eligibility 
determinations: eligibility to enroll in a qualified health plan 
through an exchange established under the ACA, eligibility for 
insurance affordability programs and certificates of exemption, and 
subsequent eligibility redeterminations and renewals, including appeal 
determinations

CATEGORIES OF RECORDS:
    The categories of records used in the matching program are identity 
and citizenship status records. The data elements are described below.
     From the CMS to USCIS. CMS will submit data elements 
pertaining to applicants and enrollees through SAVE to the USCIS VIS. 
These data elements may include the following: identification number 
(e.g., foreign passport number, I-94 number, alien registration number/
USCIS number); immigration document type; last name; middle initial; 
first name; date of birth; document expiration date (if applicable); 
and information contained in the comment field, such as USCIS benefit 
application receipt numbers, maiden names, nicknames, and additional 
immigration document numbers.
     From USCIS to CMS. USCIS through SAVE will send the Hub 
responses that contain data from records provided to VIS and databases 
VIS accesses. These responses may include

[[Page 47622]]

the following data elements: alien registration number/USCIS number; I-
94 number; last name; first name; date of birth; date of entry; status 
grant date, if available; and immigration status data.

SYSTEM OF RECORDS:
    The records used in this matching program are disclosed from the 
following systems of records, as authorized by routine uses published 
in the System of Records Notices (SORNs) cited below:
    A. CMS System of Records:
     CMS Health Insurance Exchanges System (HIX), CMS System 
No. 09-70-0560, last published in full at 78 FR 63211 (Oct. 23, 2013), 
as amended at 83 FR 6591 (Feb. 14, 2018). Routine use 3 supports CMS's 
disclosures to USCIS.
    B. USCIS System of Records:
     DHS/USCIS-004 Systematic Alien Verification for 
Entitlements Program, 81 FR 78619 (Nov. 8, 2016). Routine use H permits 
USCIS' disclosures to CMS.

[FR Doc. 2018-20510 Filed 9-19-18; 8:45 am]
 BILLING CODE 4120-03-P



                                              47620                            Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices

                                              Secretary) to publish changes to the AIC                               accordance with 42 CFR 417.600(b). The                 II. Provisions of the Notice—Annual
                                              threshold amounts in the Federal                                       Medicare Part C appeals rules also apply               AIC Adjustments
                                              Register (§ 405.1006(b)(2)). In order to                               to health care prepayment plan appeals
                                              be entitled to a hearing before an ALJ,                                in accordance with 42 CFR 417.840.                     A. AIC Adjustment Formula and AIC
                                              a party to a proceeding must meet the                                                                                         Adjustments
                                              AIC requirements at § 405.1006(b).                                     D. Medicare Part D (Prescription Drug
                                                                                                                     Plan) Appeals                                            As previously noted, section 940 of
                                              Similarly, a party must meet the AIC
                                                                                                                                                                            the MMA requires that the AIC
                                              requirements at § 405.1006(c) at the time                                 The annually adjusted AIC threshold                 threshold amounts be adjusted
                                              judicial review is requested for the court                             amounts for ALJ hearings and judicial
                                              to have jurisdiction over the appeal                                                                                          annually, beginning in January 2005, by
                                                                                                                     review that apply to Medicare Parts A,                 the percentage increase in the medical
                                              (§ 405.1136(a)).                                                       B, and C appeals also apply to Medicare                care component of the CPI for all urban
                                              B. Medicare Part C/MA Appeals                                          Part D appeals. Section 101 of the MMA                 consumers (U.S. city average) from July
                                                                                                                     added section 1860D–4(h)(1) of the Act                 2003 to July of the year preceding the
                                                 Section 940(b)(2) of the MMA applies
                                                                                                                     regarding Part D appeals. This statutory
                                              the AIC adjustment requirement to                                                                                             year involved and rounded to the
                                                                                                                     provision requires a prescription drug
                                              Medicare Part C appeals by amending                                                                                           nearest multiple of $10.
                                              section 1852(g)(5) of the Act. The                                     plan sponsor to meet the requirements
                                              implementing regulations for Medicare                                  set forth in sections 1852(g)(4) and (g)(5)            B. Calendar Year 2019
                                              Part C appeals are found at 42 CFR 422,                                of the Act, in a similar manner as MA
                                                                                                                     organizations. As noted previously, the                  The AIC threshold amount for ALJ
                                              subpart M. Specifically, §§ 422.600 and                                                                                       hearings will remain at $160 and the
                                              422.612 discuss the AIC threshold                                      annually adjusted AIC threshold
                                                                                                                     requirement was added to section                       AIC threshold amount for judicial
                                              amounts for ALJ hearings and judicial
                                                                                                                     1852(g)(5) of the Act by section                       review will rise to $1,630 for CY 2019.
                                              review. Section 422.600 grants any party
                                              to the reconsideration (except the MA                                  940(b)(2)(A) of the MMA. The                           These amounts are based on the 63.035
                                              organization) who is dissatisfied with                                 implementing regulations for Medicare                  percent increase in the medical care
                                              the reconsideration determination a                                    Part D appeals can be found at 42 CFR                  component of the CPI, which was at
                                              right to an ALJ hearing as long as the                                 423, subparts M and U. The regulations                 297.600 in July 2003 and rose to 485.193
                                              amount remaining in controversy after                                  at § 423.562(c) prescribe that, unless the             in July 2018. The AIC threshold amount
                                              reconsideration meets the threshold                                    Part D appeals rules provide otherwise,                for ALJ hearings changes to $163.04
                                              requirement established annually by the                                the Part C appeals rules (including the                based on the 63.035 percent increase
                                              Secretary. Section 422.612 states, in                                  annually adjusted AIC threshold                        over the initial threshold amount of
                                              part, that any party, including the MA                                 amount) apply to Part D appeals to the                 $100 established in 2003. In accordance
                                              organization, may request judicial                                     extent they are appropriate. More                      with section 1869(b)(1)(E)(iii) of the Act,
                                              review if the AIC meets the threshold                                  specifically, §§ 423.1970 and 423.1976                 the adjusted threshold amounts are
                                              requirement established annually by the                                of the Part D appeals rules discuss the                rounded to the nearest multiple of $10.
                                              Secretary.                                                             AIC threshold amounts for ALJ hearings                 Therefore, the CY 2019 AIC threshold
                                                                                                                     and judicial review. Section 423.1970(a)               amount for ALJ hearings is $160.00. The
                                              C. Health Maintenance Organizations,                                   grants a Part D enrollee, who is
                                              Competitive Medical Plans, and Health                                                                                         AIC threshold amount for judicial
                                                                                                                     dissatisfied with the independent
                                              Care Prepayment Plans                                                                                                         review changes to $1,630.35 based on
                                                                                                                     review entity (IRE) reconsideration
                                                                                                                                                                            the 63.035 percent increase over the
                                                Section 1876(c)(5)(B) of the Act states                              determination, a right to an ALJ hearing
                                                                                                                                                                            initial threshold amount of $1,000. This
                                              that the annual adjustment to the AIC                                  if the amount remaining in controversy
                                                                                                                     after the IRE reconsideration meets the                amount was rounded to the nearest
                                              dollar amounts set forth in section
                                              1869(b)(1)(E)(iii) of the Act applies to                               threshold amount established annually                  multiple of $10, resulting in the CY
                                              certain beneficiary appeals within the                                 by the Secretary. Sections 423.1976(a)                 2019 AIC threshold amount of $1,630.00
                                              context of health maintenance                                          and (b) allow a Part D enrollee to                     for judicial review.
                                              organizations and competitive medical                                  request judicial review of an ALJ or                   C. Summary Table of Adjustments in
                                              plans. The applicable implementing                                     Medicare Appeals Council decision if,                  the AIC Threshold Amounts
                                              regulations for Medicare Part C appeals                                in part, the AIC meets the threshold
                                              are set forth in 42 CFR 422, subpart M                                 amount established annually by the                       In the following table we list the CYs
                                              and apply to these appeals in                                          Secretary.                                             2015 through 2019 threshold amounts.

                                                                                                                                        CY 2015           CY 2016           CY 2017           CY 2018       CY 2019

                                              ALJ Hearing .........................................................................           $150                $150               $160           $160          $160
                                              Judicial Review ....................................................................            1,460               1,500              1,560         1,600         1,630



                                              III. Collection of Information                                         Paperwork Reduction Act of 1995 (44                    DEPARTMENT OF HEALTH AND
                                              Requirements                                                           U.S.C. 3501 et seq.).                                  HUMAN SERVICES
                                                This document does not impose                                          Dated: August 31, 2018.
                                                                                                                                                                            Centers for Medicare & Medicaid
amozie on DSK3GDR082PROD with NOTICES1




                                              information collection requirements,                                   Seema Verma,
                                                                                                                                                                            Services
                                              that is, reporting, recordkeeping or                                   Administrator, Centers for Medicare &
                                              third-party disclosure requirements.                                   Medicaid Services.                                     Privacy Act of 1974; Matching Program
                                              Consequently, there is no need for                                     [FR Doc. 2018–20506 Filed 9–19–18; 8:45 am]
                                              review by the Office of Management and                                 BILLING CODE 4120–01–P                                 AGENCY:  Centers for Medicare &
                                              Budget under the authority of the                                                                                             Medicaid Services (CMS), Department
                                                                                                                                                                            of Health and Human Services (HHS).


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                                                                       Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices                                            47621

                                              ACTION:Notice of New Matching                                              The
                                                                                                      SUPPLEMENTARY INFORMATION:                            immigrant, nonimmigrant, and
                                              Program.                                  Privacy Act of 1974, as amended (5                                  naturalized or derived citizenship status
                                                                                        U.S.C. 552a) provides certain                                       information from USCIS’s SAVE
                                              SUMMARY: In accordance with subsection protections for individuals applying for                               program and VIS system. This data will
                                              (e)(12) of the Privacy Act of 1974, as    and receiving federal benefits. The law                             indicate whether an applicant or
                                              amended, the Department of Health and governs the use of computer matching                                    enrollee is lawfully present, a qualified
                                              Human Services (HHS), Centers for         by federal agencies when records in a                               non-citizen, a naturalized or derived
                                              Medicare & Medicaid Services (CMS) is     system of records (meaning, federal                                 citizen, and whether the five-year
                                              providing notice of a new computer        agency records about individuals                                    waiting period for many non-citizens
                                              matching program between CMS and          retrieved by name or other personal                                 applies and has been met. CMS and
                                              the Department of Homeland Security       identifier) are matched with records of                             state administering entities will use the
                                              (DHS)/United States Citizenship and       other federal or non-federal agencies.                              data to determine the individual’s
                                              Immigration Services (USCIS),             The Privacy Act requires agencies                                   eligibility for enrollment in a qualified
                                              ‘‘Verification of United States           involved in a matching program to:                                  health plan through a federally-
                                              Citizenship and Immigration Status Data      1. Enter into a written agreement,                               facilitated exchange (FFE) and for
                                              for Eligibility Determinations.’’ In this which must be prepared in accordance                                insurance affordability programs and
                                              matching program, DHS/USCIS               with the Privacy Act, approved by the                               certificates of exemption, and to make
                                              provides CMS with immigrant,              Data Integrity Board of each source and                             eligibility redetermination and renewal
                                              nonimmigrant, and naturalized or          recipient federal agency, provided to                               decisions, including appeal
                                              derived citizenship status information    Congress and the Office of Management                               determinations. USCIS will provide the
                                              needed to make enrollment and             and Budget (OMB), and made available                                data from USCIS’s SAVE program and
                                              exemption eligibility determinations as   to the public, as required by 5 U.S.C.                              VIS system about individuals whose
                                              required by the Patient Protection and    552a(o), (u)(3)(A), and (u)(4).                                     identifying information matches
                                              Affordable Care Act (ACA).                   2. Notify the individuals whose                                  identifying information that CMS
                                              DATES: The deadline for comments on
                                                                                        information will be used in the                                     submits to USCIS. CMS will make the
                                              this notice is October 22, 2018. The re-  matching program that the information                               USCIS data available to requesting state
                                              established matching program will         they provide is subject to verification                             administering entities through a data
                                              commence not sooner than 30 days after through matching, as required by 5                                     services hub (Hub).
                                              publication of this notice, provided no   U.S.C. 552a(o)(1)(D).
                                                                                                                                                            CATEGORIES OF INDIVIDUALS:
                                                                                           3. Verify match findings before
                                              comments are received that warrant a                                                                             The individuals whose information
                                                                                        suspending, terminating, reducing, or
                                              change to this notice. The matching                                                                           will be used in the matching program
                                                                                        making a final denial of an individual’s
                                              program will be conducted for an initial                                                                      are consumers who apply for any of the
                                                                                        benefits or payments or taking other
                                              term of 18 months (from approximately                                                                         following eligibility determinations:
                                                                                        adverse action against the individual, as
                                              October 2018 to April 2020) and within                                                                        eligibility to enroll in a qualified health
                                                                                        required by 5 U.S.C. 552a(p).
                                              3 months of expiration may be renewed                                                                         plan through an exchange established
                                                                                           4. Report the matching program to
                                              for one additional year if the parties                                                                        under the ACA, eligibility for insurance
                                                                                        Congress and the OMB, in advance and
                                              make no change to the matching                                                                                affordability programs and certificates of
                                                                                        annually, as required by 5 U.S.C.
                                              program and certify that the program                                                                          exemption, and subsequent eligibility
                                                                                        552a(o) (2)(A)(i), (r), and (u)(3)(D).
                                              has been conducted in compliance with                                                                         redeterminations and renewals,
                                                                                           5. Publish advance notice of the
                                              the matching agreement.                                                                                       including appeal determinations
                                                                                        matching program in the Federal
                                              ADDRESSES: Interested parties may         Register as required by 5 U.S.C.                                    CATEGORIES OF RECORDS:
                                              submit comments on the new matching       552a(e)(12).
                                                                                                                                                               The categories of records used in the
                                              program to the CMS Privacy Officer by        This matching program meets these
                                                                                                                                                            matching program are identity and
                                              mail at: Division of Security, Privacy    requirements.
                                                                                                                                                            citizenship status records. The data
                                              Policy & Governance, Information
                                                                                        Barbara Demopulos,                                                  elements are described below.
                                              Security & Privacy Group, Office of
                                                                                        CMS Privacy Advisor, Division of Security,                             • From the CMS to USCIS. CMS will
                                              Information Technology, Centers for
                                                                                        Privacy Policy and Governance, Information                          submit data elements pertaining to
                                              Medicare & Medicaid Services,             Security and Privacy Group, Office of                               applicants and enrollees through SAVE
                                              Location: N1–14–56, 7500 Security         Information Technology, Centers for Medicare                        to the USCIS VIS. These data elements
                                              Blvd., Baltimore, MD 21244–1850, or       & Medicaid Services.                                                may include the following:
                                              walter.stone@cms.hhs.gov. Comments
                                                                                        PARTICIPATING AGENCIES:
                                                                                                                                                            identification number (e.g., foreign
                                              received will be available for review
                                                                                                                                                            passport number, I–94 number, alien
                                              without redaction unless otherwise           The Department of Health and Human
                                                                                                                                                            registration number/USCIS number);
                                              advised by the commenter at this          Services (HHS), Centers for Medicare &
                                                                                                                                                            immigration document type; last name;
                                              location, by appointment, during regular Medicaid Services (CMS) is the
                                                                                                                                                            middle initial; first name; date of birth;
                                              business hours, Monday through Friday recipient agency, and the Department of
                                                                                                                                                            document expiration date (if
                                              from 9:00 a.m. to 3:00 p.m.               Homeland Security (DHS), United States
                                                                                                                                                            applicable); and information contained
                                              FOR FURTHER INFORMATION CONTACT: If
                                                                                        Citizenship and Immigration Services
                                                                                                                                                            in the comment field, such as USCIS
                                              you have questions about the matching     (USCIS) is the source agency.
                                                                                                                                                            benefit application receipt numbers,
                                              program, you may contact Jack Lavelle,                  AUTHORITY FOR CONDUCTING THE MATCHING                 maiden names, nicknames, and
amozie on DSK3GDR082PROD with NOTICES1




                                              Senior Advisor, Marketplace Eligibility                 PROGRAM:                                              additional immigration document
                                              and Enrollment Group, Centers for                        The statutory authority for the                      numbers.
                                              Consumer Information and Insurance                      matching program is 42 U.S.C. 18001.                     • From USCIS to CMS. USCIS
                                              Oversight, CMS, at (410) 786–0639, by                                                                         through SAVE will send the Hub
                                              email at Jack.Lavelle1@cms.hhs.gov, or                  PURPOSE(S):                                           responses that contain data from records
                                              by mail at 7501 Wisconsin Ave.,                          The matching program will provide                    provided to VIS and databases VIS
                                              Bethesda, MD 20814.                                     CMS with USCIS data, including                        accesses. These responses may include


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                                              47622                    Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices

                                              the following data elements: alien                      Electronic Submissions                                with a heading or cover note that states
                                              registration number/USCIS number; I–                      Submit electronic comments in the                   ‘‘THIS DOCUMENT CONTAINS
                                              94 number; last name; first name; date                  following way:                                        CONFIDENTIAL INFORMATION.’’ The
                                              of birth; date of entry; status grant date,               • Federal eRulemaking Portal:                       Agency will review this copy, including
                                              if available; and immigration status                    https://www.regulations.gov. Follow the               the claimed confidential information, in
                                              data.                                                   instructions for submitting comments.                 its consideration of comments. The
                                                                                                      Comments submitted electronically,                    second copy, which will have the
                                              SYSTEM OF RECORDS:
                                                                                                      including attachments, to https://                    claimed confidential information
                                                 The records used in this matching                                                                          redacted/blacked out, will be available
                                              program are disclosed from the                          www.regulations.gov will be posted to
                                                                                                      the docket unchanged. Because your                    for public viewing and posted on
                                              following systems of records, as                                                                              https://www.regulations.gov. Submit
                                              authorized by routine uses published in                 comment will be made public, you are
                                                                                                      solely responsible for ensuring that your             both copies to the Dockets Management
                                              the System of Records Notices (SORNs)                                                                         Staff. If you do not wish your name and
                                              cited below:                                            comment does not include any
                                                                                                      confidential information that you or a                contact information to be made publicly
                                                 A. CMS System of Records:                                                                                  available, you can provide this
                                                 • CMS Health Insurance Exchanges                     third party may not wish to be posted,
                                                                                                      such as medical information, your or                  information on the cover sheet and not
                                              System (HIX), CMS System No. 09–70–                                                                           in the body of your comments and you
                                              0560, last published in full at 78 FR                   anyone else’s Social Security number, or
                                                                                                      confidential business information, such               must identify this information as
                                              63211 (Oct. 23, 2013), as amended at 83                                                                       ‘‘confidential.’’ Any information marked
                                              FR 6591 (Feb. 14, 2018). Routine use 3                  as a manufacturing process. Please note
                                                                                                      that if you include your name, contact                as ‘‘confidential’’ will not be disclosed
                                              supports CMS’s disclosures to USCIS.                                                                          except in accordance with 21 CFR 10.20
                                                 B. USCIS System of Records:                          information, or other information that
                                                                                                      identifies you in the body of your                    and other applicable disclosure law. For
                                                 • DHS/USCIS–004 Systematic Alien                                                                           more information about FDA’s posting
                                              Verification for Entitlements Program,                  comments, that information will be
                                                                                                      posted on https://www.regulations.gov.                of comments to public dockets, see 80
                                              81 FR 78619 (Nov. 8, 2016). Routine use                                                                       FR 56469, September 18, 2015, or access
                                                                                                        • If you want to submit a comment
                                              H permits USCIS’ disclosures to CMS.                                                                          the information at: https://www.gpo.gov/
                                                                                                      with confidential information that you
                                              [FR Doc. 2018–20510 Filed 9–19–18; 8:45 am]             do not wish to be made available to the               fdsys/pkg/FR-2015-09-18/pdf/2015-
                                              BILLING CODE 4120–03–P                                  public, submit the comment as a                       23389.pdf.
                                                                                                      written/paper submission and in the                      Docket: For access to the docket to
                                                                                                      manner detailed (see ‘‘Written/Paper                  read background documents or the
                                              DEPARTMENT OF HEALTH AND                                Submissions’’ and ‘‘Instructions’’).                  electronic and written/paper comments
                                              HUMAN SERVICES                                                                                                received, go to https://
                                                                                                      Written/Paper Submissions                             www.regulations.gov and insert the
                                              Food and Drug Administration                                                                                  docket number, found in brackets in the
                                                                                                        Submit written/paper submissions as
                                                                                                      follows:                                              heading of this document, into the
                                              [Docket No. FDA–2017–D–6526]
                                                                                                        • Mail/Hand delivery/Courier (for                   ‘‘Search’’ box and follow the prompts
                                              Grandfathering Policy for Packages                      written/paper submissions): Dockets                   and/or go to the Dockets Management
                                              and Homogenous Cases of Product                         Management Staff (HFA–305), Food and                  Staff, 5630 Fishers Lane, Rm. 1061,
                                              Without a Product Identifier; Guidance                  Drug Administration, 5630 Fishers                     Rockville, MD 20852.
                                              for Industry; Availability                              Lane, Rm. 1061, Rockville, MD 20852.                     You may submit comments on any
                                                                                                        • For written/paper comments                        guidance at any time (see 21 CFR
                                              AGENCY:    Food and Drug Administration,                submitted to the Dockets Management                   10.115(g)(5)).
                                              HHS.                                                    Staff, FDA will post your comment, as                    Submit written requests for single
                                              ACTION:   Notice of availability.                       well as any attachments, except for                   copies of this guidance to the Division
                                                                                                      information submitted, marked and                     of Drug Information, Center for Drug
                                              SUMMARY:   The Food and Drug                            identified, as confidential, if submitted             Evaluation and Research, Food and
                                              Administration (FDA or Agency) is                       as detailed in ‘‘Instructions.’’                      Drug Administration, 10001 New
                                              announcing the availability of a final                    Instructions: All submissions received              Hampshire Ave., Hillandale Building,
                                              guidance for industry entitled                          must include the Docket No. FDA–                      4th Floor, Silver Spring, MD 20993–
                                              ‘‘Grandfathering Policy for Packages and                2017–D–6526 for ‘‘Grandfathering                      0002, or the Office of Communication,
                                              Homogenous Cases of Product Without                     Policy for Packages and Homogenous                    Outreach, and Development, Center for
                                              a Product Identifier.’’ This guidance                   Cases of Product Without a Product                    Biologics Evaluation and Research,
                                              specifies whether and under what                        Identifier.’’ Received comments will be               Food and Drug Administration, 10903
                                              circumstances packages and                              placed in the docket and, except for                  New Hampshire Ave., Bldg. 71, Rm.
                                              homogenous cases of product not                         those submitted as ‘‘Confidential                     3128, Silver Spring, MD 20993–0002.
                                              labeled with a product identifier shall                 Submissions,’’ publicly viewable at                   Send one self-addressed adhesive label
                                              be grandfathered from certain                           https://www.regulations.gov or at the                 to assist that office in processing your
                                              requirements of the Federal Food, Drug,                 Dockets Management Staff between 9                    requests. See the SUPPLEMENTARY
                                              and Cosmetic Act (FD&C Act). This                       a.m. and 4 p.m., Monday through                       INFORMATION section for electronic
                                              guidance finalizes the draft guidance                   Friday.                                               access to the guidance document.
                                              issued on November 27, 2017.                              • Confidential Submissions—To                       FOR FURTHER INFORMATION CONTACT:
amozie on DSK3GDR082PROD with NOTICES1




                                              DATES: The announcement of the                          submit a comment with confidential                    Abha Kundi, Office of Compliance,
                                              guidance is published in the Federal                    information that you do not wish to be                Center for Drug Evaluation and
                                              Register on September 20, 2018.                         made publicly available, submit your                  Research, Food and Drug
                                              ADDRESSES: You may submit either                        comments only as a written/paper                      Administration, 10903 New Hampshire
                                              electronic or written comments on                       submission. You should submit two                     Ave., Silver Spring, MD 20993–0002,
                                              Agency guidances at any time as                         copies total. One copy will include the               301–796–3130, drugtrackandtrace@
                                              follows:                                                information you claim to be confidential              fda.hhs.gov.


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Document Created: 2018-09-20 02:08:15
Document Modified: 2018-09-20 02:08:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of New Matching Program.
DatesThe deadline for comments on this notice is October 22, 2018. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately October 2018 to April 2020) and within 3 months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.
ContactIf you have questions about the matching program, you may contact Jack Lavelle, Senior Advisor, Marketplace Eligibility and Enrollment Group, Centers for Consumer Information and Insurance Oversight, CMS, at (410) 786-0639, by email at [email protected], or by mail at 7501 Wisconsin Ave., Bethesda, MD 20814.
FR Citation83 FR 47620 

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