consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if

required) the review of a Section are published in the Federal Register
pursuant to paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (8) 42 CFR part 73.
    (9) 42 CFR 100.3.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec. Sec.  1.2 through 1.5  [Reserved]

CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF
HEALTH AND HUMAN SERVICES

0
3. Add part 404 to subchapter A to read as follows:

PART 404--REVIEW OF REGULATIONS

Sec.
404.1 Retrospective Review of Existing Regulations
404.2 through 404.5 [Reserved]

    Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 9701; 42 U.S.C.
263a; 42 U.S.C. 273; 42 U.S.C. 300e; 42 U.S.C. 300e-5; 42 U.S.C.
300e-9; 42 U.S.C. 405(a), 42 U.S.C. 1302; 42 U.S.C. 1306; 42 U.S.C.
1315a; 42 U.S.C. 1320a-7; 42 U.S.C. 1320a-7j; 42 U.S.C. 1320b-8; 42
U.S.C. 1320b-12; 42 U.S.C. 1395; 42 U.S.C. 1395aa(m); 42 U.S.C.
1395cc; 42 U.S.C. 1395d(d); 42 U.S.C. 1395ddd; 42 U.S.C. 1395eee(f);
42 U.S.C. 1395f(b); 42 U.S.C. 1395ff; 42 U.S.C. 1395g; 42 U.S.C.
1395hh; 42 U.S.C. 1395i; 42 U.S.C. 1395i-3; 42 U.S.C. 1395l(a), (i),
(n), and (t); 42 U.S.C. 1395jjj; 42 U.S.C. 1395kk; 42 U.S.C. 1395m;
42 U.S.C. 1395nn; 42 U.S.C. 1395rr; 42 U.S.C. 1395rr(b)(l); 42
U.S.C. 1395tt; 42 U.S.C. 1395w-5; 42 U.S.C. 1395w-101 through 1395w-
152; 42 U.S.C. 1395ww; 42 U.S.C. 1395ww(k); 42 U.S.C. 1395x;
1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16));
42 U.S.C. 1395x(v); 42 U.S.C. 1395y(a); 42 U.S.C. 1396r; 42 U.S.C.
1396r-8; 42 U.S.C. 1396u-4(f); 44 U.S.C. Chapter 35; Section 1331 of
the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-

148, 124 Stat. 119), as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat 1029); Pub. L.
112-202 amendments to 42 U.S.C. 263a; sec. 105, Pub. L. 114-10, 129
Stat. 87.

Sec.  404.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (8) The annual Medicare payment update rules.

    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec. Sec.  404.2 through 404.5  [Reserved]

CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH CARE, DEPARTMENT OF
HEALTH AND HUMAN SERVICES

0
4. Add subpart A to part 1000 to read as follows:

PART 1000--Introduction, General Definitions

Subpart A--Review of regulations

Sec.
1000.1 Retrospective Review of Existing Regulations
1000.2 through 1000.5 [Reserved]

    Authority:  5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 6101 note; 42
U.S.C. 262a; 42 U.S.C. 405(a); 42 U.S.C. 405(b); 42 U.S.C. 405(d);
42 U.S.C. 405(e); 42 U.S.C. 1302; 42 U.S.C.1320; 42 U.S.C. 1320a-
7d(b); 1320b-10; 42 U.S.C. 1320c-5; 42 U.S.C. 1395cc(b)(2)(D), (E),
and (F); 42 U.S.C. 1395cc(j); 42 U.S.C. 1395dd(d)(1); 42 U.S.C.
1395hh; 42 U.S.C. 1395mm; 42 U.S.C. 1395nn(g); 42 U.S.C. 1395ss(d);
42 U.S.C. 1395u(j); 42 U.S.C. 1395u(k); 42 U.S.C. 1395w-104(e)(6);
42 U.S.C. 1395w-141(i)(3); 42 U.S.C. 1395y(d); 42 U.S.C. 1395y(e);
42 U.S.C. 1396(a)(4)(A); 42 U.S.C. 1396a(p); 42 U.S.C. 1396a(a)(39);
42 U.S.C. 1396a(a)(41); 42 U.S.C. 1396a(a)(61); 42 U.S.C.
1396b(a)(6); 42 U.S.C. 1396b(b)(3); 42 U.S.C. 1396b(i)(2); 42 U.S.C.
1396b(m); 42 U.S.C. 1396b(q); 42 U.S.C. 1842(j)(1)(D)(iv); 42 U.S.C.
1842(k)(1); 42 U.S.C. 11131(c); 42 U.S.C. 11137(b)(2).

Sec.  1000.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the

Department shall have two years from the date that the findings of the
review are published in the Federal Register pursuant to paragraph (f)
of this section to amend or rescind the Section. If the Secretary
determines that completion of the amendment or rescission is not
feasible by the established date, he shall so certify in a statement
published in the Federal Register and may extend the completion date by
one year at a time, no more than three times, for a total of not more
than five years (inclusive of the initial two-year period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (8) 42 CFR 1001.952.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec. Sec.  1000.2 through 1000.5  [Reserved]

Title 45--Public Welfare

Subtitle A--Department of Health and Human Services

0
5. Add part 8 to read as follows:

PART 8--REVIEW OF REGULATIONS

Sec.
8.1 Retrospective Review of Existing Regulations
8.2 through 8.5 [Reserved]

    Authority: 5 U.S.C. 301; 5 U.S.C. 504(c)(1); 5 U.S.C. 552; 5
U.S.C. 552a; 5 U.S.C. 553; 5 U.S.C. 5514; 5 U.S.C. 7301; 8 U.S.C.
1182(e)); 8 U.S.C. 1182(j)(2)(A); 18 U.S.C. 207(j); 18 U.S.C. 1905;
20 U.S.C. 91; 20 U.S.C. 1405; 20 U.S.C. 1681 et seq.; 20 U.S.C. 1681
through 1688; 21 U.S.C. 1174; 22 U.S.C. 2151b(f) (e.g., Pub. L. 116-
6, Div. F, sec. 7018); 22 U.S.C. 2451 et seq.; 22 U.S.C. 7631(d); 22
U.S.C. 7631(f); 26 U.S.C. 36B; 26 U.S.C. 5000A(d)(2); 28 U.S.C.
2672; 29 U.S.C. 669(a)(5); 29 U.S.C. 794; 31 U.S.C. 1243 note; 31
U.S.C. 1352; 31 U.S.C. 3711(d); 31 U.S.C. 3720A; 31 U.S.C. 3720D; 31
U.S.C. 3721; 31 U.S.C. 3801-3812; 31 U.S.C. 6506; 31 U.S.C. 7501-
7507; 31 U.S.C. 9701; 40 U.S.C. 121(c); 40 U.S.C. 318-318d; 40
U.S.C. 484; 40 U.S.C. 484(k); 40 U.S.C. 486; 42 U.S.C. 216; 42
U.S.C. 216(b); 42 U.S.C. 238n; 42 U.S.C. 263a(f)(1)(E); 42 U.S.C.
280g-1(d); 42 U.S.C. 289(a); 42 U.S.C. 289b-1; 42 U.S.C. 290bb-
36(f); 42 U.S.C. 290dd-2; 42 U.S.C. 299c-4; 42 U.S.C. 300a-7; 42
U.S.C. 300aa-11; 42 U.S.C. 300gg through 300gg-63; 42 U.S.C. 300gg-1
through 300gg-5; 42 U.S.C. 300gg-11 through 300gg-23; 42 U.S.C.
300gg-18; 42 U.S.C. 300gg-91; 42 U.S.C. 300gg-92; 42 U.S.C. 300gg-
94; 42 U.S.C. 300jj-11; 42 U.S.C 300jj-14; 42 U.S.C. 300jj-52; 42
U.S.C. 300w et seq.; 42 U.S.C. 300x et seq.; 42 U.S.C. 300y et seq.;
42 U.S.C. 618; 42 U.S.C. 622(b); 42 U.S.C. 629b(a); 42 U.S.C.
652(a); 42 U.S.C. 652(d); 42 U.S.C. 654A; 42 U.S.C. 671(a); 42
U.S.C. 701 et seq.; 42 U.S.C. 1302; 42 U.S.C. 1302(a); 42 U.S.C.
1306(c); 42 U.S.C. 1310; 42 U.S.C. 1315; 42 U.S.C. 1315a; 42 U.S.C.
1320a-1; 42 U.S.C. 1320a-7e; 42 U.S.C. 1320c-11; 42 U.S.C.
1395cc(f); 42 U.S.C. 1320d-2 (note); 42 U.S.C. 1320d-1320d-9; 42
U.S.C. 1395i-3; 42 U.S.C. 1395i-5; 42 U.S.C. 1395w-22(j)(3)(B); 42
U.S.C. 1395w-26; 42 U.S.C. 1395w-27; 42 U.S.C. 1395x; 42 U.S.C.
1396a; 42 U.S.C. 1396a(a); 42 U.S.C. 1396a(w)(3); 42 U.S.C. 1396f;
42 U.S.C. 1396r; 42 U.S.C. 1396r-2; 42 U.S.C. 1396s(c)(2)(B)(ii); 42
U.S.C. 1396u-2(b)(3)(B); 42 U.S.C. 1397 et seq.; 42 U.S.C. 1397j-
1(b); 42 U.S.C. 2000d et seq.; 42 U.S.C. 2000d-1; 42 U.S.C. 2942; 42
U.S.C. 3334; 42 U.S.C. 3505; 42 U.S.C. 3535(d); 42 U.S.C. 5106i(a);
42 U.S.C. 6101 et seq.; 42 U.S.C. 8621 et seq.; 42 U.S.C. 9858; 42
U.S.C. 9901 et seq.; 42 U.S.C. 11101-11152; 42 U.S.C. 11411; 42
U.S.C. 14406; 42 U.S.C. 18021-18024; 42 U.S.C. 18031-18033; 42
U.S.C. 18041(a); 42 U.S.C. 18041-18042; 42 U.S.C. 18044; 42 U.S.C.
18051; 42 U.S.C. 18054; 42 U.S.C. 18061 through 18063; 42 U.S.C.
18071; 42 U.S.C. 18081-18083; 42 U.S.C. 18113; 42 U.S.C. 18116; 48
U.S.C. 1469a; 50 U.S.C. App. 2061-2171; 27 Stat. 395; Sec. 1(a), 80
Stat. 306; secs. 1, 5, 6, and 7 of Reorganization Plan No. 1 of
1953, 18 FR 2053, 67 Stat. 631 and authorities cited in the
Appendix; Sec. 203, 63 Stat. 385; Section 213, Uniform Relocation
Assistance and Real Property Acquisition Policies Act of 1970, Pub.
L. 91-646, 84 Stat. 1894 (42 U.S.C. 4633) as amended by the Surface
Transportation and Uniform Relocation Assistance Act of 1987, Title
IV of Pub. L. 100-17, 101 Stat. 246-256 (42 U.S.C. 4601 note); Sec.
223, 58 Stat. 683, as amended by 81 Stat. 539: 42 U.S.C. 217b; Sec.
602, 78 Stat. 252; Sec. 501 of Pub. L. 100-77, 101 Stat. 509-10, 42
U.S.C 11411; Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988); 5 U.S.C.
301, Pub. L. 100-259, 102 Stat. 28 (Mar. 22 1988); Public Law 101-
410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812; Section
5301 of Pub. L. 100-690, the Anti-Drug Abuse Act of 1988, 102 Stat.
4310, 21 U.S.C. 853a; secs. 13400-13424, Pub. L. 111-5, 123 Stat.
258-279; Sec. 1101 of the Patient Protection and Affordable Care Act
(Pub. L. 111-148); Section 1103 of the Patient Protection and
Affordable Care Act (Pub. L. 111-148); secs. 1104 and 10109 of Pub.
L. 111-148, 124 Stat. 146-154 and 915-917; Title I of the Affordable
Care Act, Sections 1311, 1312, 1411, 1412, Pub. L. 111-148, 124
Stat. 119; Medicare Advantage (e.g., Pub. L. 115-245, Div. B, sec.
209); the Weldon Amendment (e.g., Pub. L. 115-245, Div. B, sec.
507(d)); 5 U.S.C. 610.

Sec.  8.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this subtitle.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in

consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (8) The annual Notice of Benefit and Payment Parameters update
rules.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by

which comments must be received. There shall also be a general docket
on Regulations.gov where the public can submit comments requesting that
the Department assess or review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  8.2 through 8.5   [Reserved]

Subtitle B--Regulations Relating to Public Welfare

CHAPTER II--OFFICE OF FAMILY ASSISTANCE (ASSISTANCE PROGRAMS),
ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND
HUMAN SERVICES

0
6. Add part 200 to read as follows:

PART 200--REVIEW OF REGULATIONS

Sec.
200.1 Retrospective Review of Existing Regulations
200.2 through 200.5 [Reserved]

    Authority: 5 U.S.C. 301; 5 U.S.C. 610; 24 U.S.C. 321-329; 31
U.S.C. 7501 et seq.; 42 U.S.C. 301; 42 U.S.C. 303; 42 U.S.C. 601; 42
U.S.C. 601 note; 42 U.S.C. 602; 42 U.S.C. 602 (note); 42 U.S.C.
602(a)(44); 42 U.S.C. 603; 42 U.S.C. 603(a)(4); 42 U.S.C. 604; 42
U.S.C. 605; 42 U.S.C. 606; 42 U.S.C. 607; 42 U.S.C. 608; 42 U.S.C.
609; 42 U.S.C. 610; 42 U.S.C. 611; 42 U.S.C. 612; 42 U.S.C. 613; 42
U.S.C. 613(i); 42 U.S.C. 616; 42 U.S.C. 619; 42 U.S.C. 654; 42
U.S.C. 862a; 42 U.S.C. 1202; 42 U.S.C. 1203; 42 U.S.C. 1301; 42
U.S.C. 1302; 42 U.S.C. 1306(a); 42 U.S.C. 1308; 42 U.S.C. 1313; 42
U.S.C. 1316; 1320b-7: 42 U.S.C. 1973gg-5; 42 U.S.C. 1337; 42 U.S.C.
1352; 42 U.S.C. 1353; 42 U.S.C. 1382 (note); 42 U.S.C. 1383 (note);
sections 1, 5, 6, and 7 of Reorganization Plan No. 1 of 1953, 67
Stat. 631; Secs. 1-11, 74 Stat. 308-310; Sec. 302, 75 Stat. 142,
sec. 1102, 49 Stat. 647; sec. 6 of Pub. L. 94-114, 89 Stat. 579;
Pub. L. No. 97-248, 96 Stat. 324, and Pub. L. No. 99-603, 100 Stat.
3359; sec. 4 of Pub. L. 97-458, 96 Stat. 2513; sec. 2 of Pub. L. 98-
64, 97 Stat. 365; sec. 1883 of Pub. L. 99-514, 100 Stat. 2916; sec.
15 of Pub. L. 100-241, 101 Stat. 1812; sec. 105(f) of Pub. L. 100-
383, 102 Stat. 908; sec. 206(d) of Pub. L. 100-383, 102 Stat. 914;
sec. 105(i) of Pub. L. 100-707, 102 Stat. 4693; sec. 1(a) of Pub. L.
101-201, 103 Stat. 1795; sec. 10405 of Pub. L. 101-239, 103 Stat.
2489; sec. 501(c) of Pub. L. 101-392, 104 Stat. 831; sec. 6(h)(2) of
Pub. L. 101-426, 104 Stat. 925; and sec. 471(a) of Pub. L. 102-325,
106 Stat. 606; Sec. 7102, Pub. L. 109-171, 120 Stat. 135; Public Law
111-5; Sec. 4004, Pub. L. 112-96, 126 Stat. 197; 49 Stat. 647.

Sec.  200.1   Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.

    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting.The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  200.2 through 200.5  [Reserved]

CHAPTER III--OFFICE OF CHILD SUPPORT ENFORCEMENT (CHILD SUPPORT
ENFORCEMENT PROGRAM), ADMINISTRATION FOR CHILDREN AND FAMILIES,
DEPARTMENT OF HEALTH AND HUMAN SERVICES

0
7. Add part 300 to read as follows:

PART 300--REVIEW OF REGULATIONS

Sec.
300.1 Retrospective Review of Existing Regulations
300.2 through 300.5 [Reserved]

    Authority: 5 U.S.C. 301; 5 U.S.C. 610; 25 U.S.C. 1603(12); 25
U.S.C. 1621e; 42 U.S.C. 609(a)(8); 42 U.S.C. 651 through 658; 42
U.S.C. 652(a)(4) and (g); 42 U.S.C. 654(15)(A); 42 U.S.C. 655(f); 42
U.S.C. 658a; 42 U.S.C. 659a; 42 U.S.C. 660; 42 U.S.C. 663; 42 U.S.C.
664; 42 U.S.C. 666 through 669A; 42 U.S.C. 1301; 42 U.S.C. 1302; 42
U.S.C. 1396a(a)(25); 42 U.S.C. 1396b(d)(2); 42 U.S.C. 1396b(o); 42
U.S.C. 1396b(p); 42 U.S.C. 1396(k).

Sec.  300.1   Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination,

which shall not exceed one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  300.2 through 300.5  [Reserved]

CHAPTER IV--OFFICE OF REFUGEE RESETTLEMENT, ADMINISTRATION FOR
CHILDREN AND FAMILIES DEPARTMENT OF HEALTH AND HUMAN SERVICES

0
8. Add part 403 to read as follows:

PART 403--REVIEW OF REGULATIONS

Sec.
403.1 Retrospective Review of Existing Regulations
403.2 through 403.5 [Reserved]

    Authority:  5 U.S.C. 301; 5 U.S.C. 610; 6 U.S.C. 279; 8 U.S.C.
1103(a)(3); 8 U.S.C. 1232; 8 U.S.C. 1255a note; 8 U.S.C. 1522 note;
8 U.S.C. 1522(a)(9); 42 U.S.C. 15607(d).

Sec.  403.1   Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.

    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  403.2 through 403.5  [Reserved]

CHAPTER X--OFFICE OF COMMUNITY SERVICES, ADMINISTRATION FOR
CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES

0
9. Add part 1010 to read as follows:

PART 1010--REVIEW OF REGULATIONS

Sec.
1010.1 Retrospective Review of Existing Regulations
1010.2 through 1010.5 [Reserved]

    Authority:  5 U.S.C. 301; 5 U.S.C. 610; 42 U.S.C. 604 nt.; 42
U.S.C. 9901 et seq.; 42 U.S.C. 11302 (101 Stat. 485); 42 U.S.C.
11461-11464; 42 U.S.C. 11472 (101 Stat. 532-533).

Sec.  1010.1   Retrospective Review of Existing Regulations

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was promulgated or the last time the rulemaking was reviewed
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.

    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  1010.2 through 1010.5  [Reserved]

CHAPTER XIII--ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT
OF HEALTH AND HUMAN SERVICES

0
10. Add subchapter A to read as follows:

SUBCHAPTER A--[include your preferred subchapter heading]

PART 1300--REVIEW OF REGULATIONS

Sec.
1300.1 Retrospective Review of Existing Regulations.
1300.2 through 1390.5 [Reserved]

    Authority:  5 U.S.C. 301; 5 U.S.C. 610; 29 U.S.C. 709; 29 U.S.C.
3343; 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq.; 42 U.S.C. 1302;
42 U.S.C. 1395b-4; 42 U.S.C. 2991, et seq.; 42 U.S.C. 3001 et seq.;
Title III of the Older Americans Act; 42 U.S.C. 3001; Title VI, Part
A of the Older Americans Act; 42 U.S.C. 3001; Title VI Part B of the
Older Americans Act; 42 U.S.C. 3515e; 42 U.S.C. 5701; 42 U.S.C. 9801
et seq.; 42 U.S.C. 10401 et seq.; 42 U.S.C. 15001 et seq.

Sec.  1300.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all
regulations issued by the Secretary or his delegates or sub-delegates
in this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in
consultation with other Federal agencies as appropriate, as to whether
the Sections issued as part of the same rulemaking (and any amendments
or additions that may have been added thereafter) currently have a
significant economic impact upon a substantial number of small
entities.
    (2) Review shall refer to a process conducted by the Department, in
consultation with other Federal agencies as appropriate, the purpose of
which shall be to determine whether Sections that were issued as part
of the same rulemaking (and any amendments or additions that may have
been issued thereafter) should be continued without change, or should
be amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize any significant economic impact of the
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the
Section first became effective, irrespective of whether it was
subsequently amended.
    (5) Significant economic impact upon a substantial number of small
entities shall have the meaning of that term in section 610 of title 5
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all
Sections issued by the Secretary or his delegates or sub-delegates in
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first
becomes effective;
    (ii) Ten calendar years after the year of the Section's
promulgation; or
    (iii) Ten calendar years after the last year in which the
Department assessed and (if review of the Section is required pursuant
to paragraph (d) of this section) reviewed the Section, whichever is
latest.
    (2) The last year in which the Department assessed and (if review
of the Section is required) reviewed the Section shall be the year
during which the findings of the assessment and (if required) the
review of a Section are published in the Federal Register pursuant to
paragraph (f) of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph
(c)(1) of this section, the Secretary makes a written determination
that the public interest requires continuation of the Section in force
beyond the date on which the Section would otherwise expire under
paragraph (c)(1), the Secretary may continue the Section in force one
time for a period stated in the determination, which shall not exceed
one calendar year.
    (ii) The Department shall promptly publish in the Federal Register
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of
this section is not delegable and may be exercised only by the
Secretary or, when the office of the Secretary is vacant or the
Secretary has become unable to perform the functions and duties of the
office of the Secretary, by the individual acting as Secretary in
accordance with the law.
    (d) The Department is required to review those rulemakings (and any
amendments or additions that may have been added thereafter) that the
Department assesses have a significant economic impact upon a
substantial number of small entities. In reviewing rulemakings to
minimize any significant economic impact on a substantial number of
small entities in a manner consistent with the stated objectives of
applicable statutes, the Department's review shall consider the
following factors:
    (1) The continued need for the rulemaking, consideration of which
shall include but not be limited to the extent to which the rulemaking
defines terms or sets standards used in or otherwise applicable to
other Federal rules;
    (2) The nature of complaints or comments received concerning the
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or
conflicts with other Federal rules, and, to the extent feasible, with
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other
factors have changed in the area affected by the rulemaking since the
rulemaking was

promulgated or the last time the rulemaking was reviewed by the
Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or
rescinded, the Department shall have two years from the date that the
findings of the review are published in the Federal Register pursuant
to paragraph (f) of this section to amend or rescind the Section. If
the Secretary determines that completion of the amendment or rescission
is not feasible by the established date, he shall so certify in a
statement published in the Federal Register and may extend the
completion date by one year at a time, no more than three times, for a
total of not more than five years (inclusive of the initial two-year
period).
    (f) The results of all assessments and reviews conducted in a
calendar year, including the full underlying analyses and data used to
support the results (subject to any applicable privilege, protections
for confidential business information, or explicit legal prohibition on
disclosure), shall be published in a single document in the Federal
Register during that calendar year. The document shall be organized in
a manner that enables both the Department and the public to readily
determine which assessments and reviews were conducted during that
calendar year. The document shall also specify the year by which the
next assessment (and, if required, the next review) of the Section
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section. For Sections
described in this paragraph (g)(1) that are adopted after the effective
date of this section, the Federal law described in this paragraph
(g)(1) shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would
violate any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of
the United States.
    (5) Sections addressed solely to internal agency management or
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies,
or that were issued in consultation with other agencies because of a
legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an
assessment or review, it shall state on a Department-managed website
the Section(s) whose assessment or review it is commencing. It shall
also announce once a month in the Federal Register those new
assessments or reviews that it has commenced in the last month. The
Department will create a docket on Regulations.gov for each assessment
or review that the Department is conducting. The public will be able to
submit comments to the dockets of each rulemaking being assessed or
reviewed. Each docket shall specify the date by which comments must be
received. There shall also be a general docket on Regulations.gov where
the public can submit comments requesting that the Department assess or
review a Section.
    (i) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Sec.  1300.2 through 1300.5   [Reserved]

    Dated: January 8, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-00597 Filed 1-15-21; 8:45 am]
BILLING CODE 4150-26-P


MEMORANDUM

To:		Docket EPA - HQ - OAR - 2016 - 0490

From: 	Karen Marsh, U.S. EPA, OAQPS, Sector Policies and Programs Division

--------------------------------------------------------------------------------
Subject:	NACWA Meeting -- Proposed NESHAP for POTW
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Date: 	January 11 and February 16, 2017
--------------------------------------------------------------------------------

Representatives of EPA/OAQPS/SPPD met with members of the National Association of Clean Water Agencies (NACWA) over the course of two meetings to discuss the proposed revisions to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Publicly Owned Treatment Works (POTW). The purpose of the meetings was for EPA to walk attendees through the proposed rule, listen to stakeholder concerns, and answer limited questions about the proposed rule. These meetings took place during the public comment period for the proposed rule (81 FR 95352, December 27, 2016) and stakeholders were encouraged to submit written comments on the proposed rule.

The attendees listed in Attachment A were on at least one of the two calls. In additional to the attendees listed in Attachment A, David Cozzie and Karen Marsh were in attendance from EPA.

Stakeholder Topics/Questions/Concerns:

One stakeholder asked if the industrial and commercial facilities must have HAP in their wastewater in order for the POTW to potentially be subject to the rule. EPA indicated that HAP emissions were one of the applicability criteria, therefore, if a wastewater stream did not contain HAP, it would not contribute to the potential emissions at the POTW when determining whether the POTW is a major source.

Stakeholders requested a variation of the reporting timeline and indicated that the first quarter of the year is heavily focused on reporting for several different programs, including NPDES, TRI, and emission inventories. They requested that annual reporting be due outside of the first quarter of the calendar year to ease burden.

One stakeholder indicated they are subject to the rule because they are collocated with engines that are a major source of HAP. They asked if they took a limit on those engines to become a synthetic area source, would they no longer be subject to the POTW NESHAP. EPA stated they would look into this issue.

One stakeholder indicated they had not identified a lab that could address all 187 HAP.

Several stakeholders stated they are working to collect data to submit to EPA but were concerned about having that data available within the comment period. EPA indicated they could discuss extending the comment period if requested.
Stakeholders asked how they would develop a process to determine which HAP they needed to be concerned about entering their POTW and becoming an air emission source. One commenter stated they utilize a combination of ToxChem+ and source testing to determine emissions and identify the HAP of concern. Another commenter stated they use TRI screening to determine which pollutants they should add to their monitoring program.

One stakeholder asked how many POTW that have design capacities between 5 and 20 million gallons per day (MGD) have data on HAP other than their priority pollutant list from their NPDES program.

On February 16, 2017, EPA spoke with Cynthia Finley of NACWA to discuss additional comments and questions. Further EPA discussed the approval of a comment extension for 30 days (ending March 29, 2017). Ms. Finely identified key items that would be provided in the formal comments from NACWA as outline below:

Collection system have not previously been looked at for emissions and were not included originally in the major source determination calculations. There are several questions over what part of the collection system is owned by the POTW as satellite systems often discharge to larger utilities.

The treatment plant has always been considered as the source of emissions when determining if the POTW is a major source.

There are some helpful clarifications in the rule as proposed.

There is no objection to moving pretreatment out of the applicability criteria.

The proposed applicability should not trigger major source exceedances for any existing POTW not already subject to the rule. There is a concern that inclusion of the collection system emissions would pull in additional POTW.

The HAP fraction as proposed seems reasonable but there is at least 1 POTW that is not sure if they could continuously meet this limit. There is lack of clarity over EPA's goal in setting the HAP fraction limit and the cost for monthly monitoring was not accounted for in the proposed cost estimates.

EPA requested that the items outlined be included in the formal comment submission to the docket.