380 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Rules and Regulations 

period and subsequent embryo 

extraction; and 

(v) Ability of the device to permit 

oxygen and carbon dioxide exchange 

between the media contained within the 

device and the external environment 

throughout the vaginal incubation 

period. 

(3) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(4) Performance data must 

demonstrate the sterility of the device 

components intended to be provided 

sterile. 

(5) Shelf life testing must demonstrate 

that the device maintains its 

performance characteristics and the 

packaging of device components labeled 

as sterile maintain integrity and sterility 

for the duration of the shelf life. 

(6) Labeling for the device must 

include: 

(i) A detailed summary of the clinical 

testing, including device effectiveness, 

device-related complications, and 

adverse events; 

(ii) Validated methods and 

instructions for reprocessing of reusable 

components; 

(iii) The maximum number of gametes 

or embryos that can be loaded into the 

device; 

(iv) A warning that informs users that 

the embryo development is first 

evaluated following intravaginal 

culture; and 

(v) A statement that instructs the user 

to use legally marketed assisted 

reproductive technology media that 

contain elements to mitigate the 

contamination risk (e.g., antibiotics) and 

to support continued embryonic 

development over the intravaginal 

culture period. 

(7) Patient labeling must be provided 

and must include: 

(i) Relevant warnings, precautions, 

and adverse effects and complications; 

(ii) Information on how to use the 

device; 

(iii) The risks and benefits associated 

with the use of the device; and 

(iv) A summary of the principal 

clinical device effectiveness results. 

Dated: December 30, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–33264 Filed 1–5–16; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 62 

[EPA–R07–OAR–2015–0733; FRL–9941–06– 

Region 7] 

Approval and Promulgation of State 

Plans for Designated Facilities and 

Pollutants; Nebraska; Sewage Sludge 

Incinerators 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking direct final 

action to approve the Clean Air Act 

(CAA) section 111(d)/129 negative 

declaration for the state of Nebraska, for 

existing sewage sludge incinerator (SSI) 

units. This negative declaration certifies 

that existing SSI units subject to 

sections 111(d) and 129 of the CAA do 

not exist within the jurisdiction of 

Nebraska. EPA is accepting the negative 

declaration in accordance with the 

requirements of the CAA. 

DATES: This direct final rule will be 

effective March 7, 2016, without further 

notice, unless EPA receives adverse 

comment by February 5, 2016. If EPA 

receives adverse comment, we will 

publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the rule will 

not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R07– 

OAR–2015–0733, to http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

The EPA may publish any comment 

received to its public docket. Do not 

submit electronically any information 

you consider to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Paula Higbee, Environmental Protection 

Agency, Air Planning and Development 

Branch, 11201 Renner Boulevard, 

Lenexa, Kansas 66219 at 913–551–7028 

or by email at higbee.paula@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document ‘‘we,’’ ‘‘us,’’ 

or ‘‘our’’ refer to EPA. This section 

provides additional information by 

addressing the following: 

I. Background 

II. Analysis of State Submittal 

III. Statutory and Executive Order Reviews 

I. Background 

The CAA requires that state regulatory 

agencies implement the emission 

guidelines and compliance times using 

a state plan developed under sections 

111(d) and 129 of the CAA. The general 

provisions for the submittal and 

approval of state plans are codified in 

40 CFR part 60, subpart B and 40 CFR 

part 62, subpart A. Section 111(d) 

establishes general requirements and 

procedures on state plan submittals for 

the control of designated pollutants. 

Section 129 requires emission 

guidelines to be promulgated for all 

categories of solid waste incineration 

units, including SSI units. Section 129 

mandates that all plan requirements be 

at least as protective and restrictive as 

the promulgated emission guidelines. 

This includes fixed final compliance 

dates, fixed compliance schedules, and 

Title V permitting requirements for all 

affected sources. Section 129 also 

requires that state plans be submitted to 

EPA within one year after EPA’s 

promulgation of the emission guidelines 

and compliance times. 

States have options other than 

submitting a state plan in order to fulfill 

their obligations under CAA sections 

111(d) and 129. If a State does not have 

any existing Sewage Sludge Incineration 

(SSI) units for the relevant emissions 

guidelines, a letter can be submitted 

certifying that no such units exist 

within the State (i.e., negative 

declaration) in lieu of a state plan. The 

negative declaration exempts the State 

from the requirements of subpart B that 

would otherwise require the submittal 

of a CAA section 111(d)/129 plan. 

On March 21, 2011 (76 FR 15372), the 

EPA established emission guidelines 

and compliance times for existing SSI 

units. The emission guidelines and 

compliance times are codified at 40 CFR 

60, Subpart MMMM. In order to fulfill 

obligations under CAA sections 111(d) 

and 129, NDEQ submitted a negative 

declaration letter to EPA on December 6, 

2012. The submittal of this declaration 

exempts NDEQ from the requirement to 


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Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Rules and Regulations 381 

submit a state plan for existing SSI 

units. 

II. Analysis of State Submittal 

In this Direct Final action, EPA is 

amending part 62 to reflect receipt of 

the negative declaration letter from the 

NDEQ, certifying that there are no 

existing SSI units subject to 40 CFR part 

60, subpart MMMM, in accordance with 

Section 111(d) of the CAA. If a 

designated facility (i.e., existing SSI 

unit) is later found within NDEQ’s 

jurisdiction after publication of this 

Federal Register action, then the 

overlooked facility will become subject 

to the requirements of the Federal plan 

for that designated facility, including 

the compliance schedule. The Federal 

plan will no longer apply, if we 

subsequently receive and approve the 

111(d) plan from the jurisdiction with 

the overlooked facility. EPA is 

publishing this direct final rule without 

a prior proposed rule because we view 

this as a noncontroversial action and 

anticipate no adverse comment. 

However, in the ‘‘Proposed Rules’’ 

section of this Federal Register, we are 

publishing a separate document that 

will serve as the proposed rule to 

approve the negative declaration if 

adverse comments are received on this 

direct final rule. We will not institute a 

second comment period on this action. 

Any parties interested in commenting 

must do so at this time. For further 

information about commenting on this 

rule, see the ADDRESSES section of this 

document. If EPA receives adverse 

comment, we will publish a timely 

withdrawal in the Federal Register 

informing the public that this direct 

final rule will not take effect. We will 

address all public comments in any 

subsequent final rule based on the 

proposed rule. 

III. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

therefore is not subject to review by the 

Office of Management and Budget. For 

this reason, this action is also not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This action merely approves 

state law as meeting Federal 

requirements and imposes no additional 

requirements beyond those imposed by 

state law. Accordingly, the 

Administrator certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities under the Regulatory Flexibility 

Act (5 U.S.C. 601 et seq.). Because this 

rule approves pre-existing requirements 

under state law and does not impose 

any additional enforceable duty beyond 

that required by state law, it does not 

contain any unfunded mandate or 

significantly or uniquely affect small 

governments, as described in the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). This action is not 

approved to apply on any Indian 

reservation land or in any other area 

where EPA or an Indian tribe has 

demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). This 

action also does not have Federalism 

implications because it does not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

approves a state rule implementing a 

Federal requirement, and does not alter 

the relationship or the distribution of 

power and responsibilities established 

in the Act. This rule also is not subject 

to Executive Order 13045 (62 FR 19885, 

April 23, 1997), because it approves a 

state rule implementing a Federal 

standard. In reviewing section 111(d)/

129 plan submissions, EPA’s role is to 

approve State choices, provided that 

they meet the criteria of the Act. In this 

context, in the absence of a prior 

existing requirement for the State to use 

voluntary consensus standards (VCS), 

EPA has no authority to disapprove a 

section 111(d)/129 plan submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a section 111(d)/ 

129 plan submission, to use VCS in 

place of a section 111(d)/129 plan 

submission that otherwise satisfies the 

provisions of the Act. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. This rule does 

not impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

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

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by March 7, 2016. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action 

approving Nebraska’s section 111(d)/

129 plan revision for SSI sources may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2)). 

List of Subjects in 40 CFR Part 62 

Environmental protection, Air 

pollution control, Administrative 

practice and procedure, 

Intergovernmental relations, Reporting 

and recordkeeping requirements, 

Sewage sludge incinerators. 

Dated: December 23, 2015. 

Mark Hague, 

Regional Administrator, Region 7. 

For the reasons stated in the 

preamble, EPA amends 40 CFR part 62 

as set forth below: 

PART 62—APPROVAL AND 

PROMULGATION OF STATE PLANS 

FOR DESIGNATED FACILITIES AND 

POLLUTANTS 

■ 1. The authority citation for part 62 

continues to read as follows: 

Authority: 42 U.S.C. et seq. 

Subpart CC—Nebraska 

* * * * * 

■ 2. Subpart CC is amended by adding 

an undesignated center heading and 

§ 62.6917 to read as follows: 


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382 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Rules and Regulations 

1See 18 U.S.C. 922(g) and (n) and implementing 

regulations at 27 CFR 478.11 and 27 CFR 478.32. 

2The regulation, at 27 CFR 478.11, defines 

‘‘Committed to a mental institution’’ as a formal 

commitment to the institution by a court or other 

lawful authority. The term does not apply to a 

person voluntarily admitted to a mental institution 

or in a mental institution merely for observation. 

3The term used in the statute is ‘‘adjudicated as 

a mental defective. The term includes a finding of 

insanity in a criminal case, and a finding of 

incompetence to stand trial or a finding of not 

guilty by reason of lack of mental responsibility 

pursuant to the Uniform Code of Military Justice. 

27 CFR 478.11. 

4This rule refers to the involuntary commitments 

and other applicable adjudications as, collectively, 

‘‘adjudications that make an individual subject to 

the Federal mental health prohibitor.’’ 

5See Public Law 103–159, 18 U.S.C. 921–925, 

and implementing regulations at 28 CFR 25.1 

through 25.11 (establishing NICS information 

system specifications and processes) and 27 CFR 

part 478 (establishing requirements and 

prohibitions for commerce in firearms and 

ammunition, including requirements related to 

conducting NICS background checks); and 42 

U.S.C. 3759(b) (allocating a percentage of certain 

DOJ funds for State reporting of NICS data). 

6See Statement Before the Senate Judiciary 

Committee, Subcommittee on Crime and Terrorism 

at a hearing entitled, ‘‘THE FIX GUN CHECKS ACT: 

BETTER STATE AND FEDERAL COMPLIANCE, 

SMARTER ENFORCEMENT’’ (November 15, 2011), 

by David Cuthbertson, Assistant Director, Criminal 

Justice Information Services Division, Federal 

Bureau of Investigation. Testimony available at: 

http://www.justice.gov/ola/testimony/112-1/11-15- 

11-fbi-cuthbertson-testimony-re-the-fix-gun-checksAir Emissions Standards of 

Performance for New Sewage Sludge 

Incinerators 

§ 62.6917 Identification of plan—negative 

declaration. 

Letter from the Nebraska Department 

of Environmental Quality received 

December 6, 2012, certifying that there 

are no Sewage Sludge Incinerator units 

subject to 40 CFR part 60, subpart 

MMMM. 

[FR Doc. 2015–33292 Filed 1–5–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 164 

Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule and the National Instant Criminal 

Background Check System (NICS) 

AGENCY: Office for Civil Rights, 

Department of Health and Human 

Services. 

ACTION: Final rule. 

SUMMARY: The Department of Health and 

Human Services (HHS or ‘‘the 

Department’’) is issuing this final rule to 

modify the Health Insurance Portability 

and Accountability Act of 1996 (HIPAA) 

Privacy Rule to expressly permit certain 

HIPAA covered entities to disclose to 

the National Instant Criminal 

Background Check System (NICS) the 

identities of individuals who are subject 

to a Federal ‘‘mental health prohibitor’’ 

that disqualifies them from shipping, 

transporting, possessing, or receiving a 

firearm. The NICS is a national system 

maintained by the Federal Bureau of 

Investigation (FBI) to conduct 

background checks on persons who may 

be disqualified from receiving firearms 

based on Federally prohibited categories 

or State law. Among the persons subject 

to the Federal mental health prohibitor 

established under the Gun Control Act 

of 1968 and implementing regulations 

issued by the Department of Justice 

(DOJ) are individuals who have been 

involuntarily committed to a mental 

institution; found incompetent to stand 

trial or not guilty by reason of insanity; 

or otherwise have been determined by a 

court, board, commission, or other 

lawful authority to be a danger to 

themselves or others or to lack the 

mental capacity to contract or manage 

their own affairs, as a result of marked 

subnormal intelligence or mental 

illness, incompetency, condition, or 

disease. Under this final rule, only 

covered entities with lawful authority to 

make the adjudications or commitment 

decisions that make individuals subject 

to the Federal mental health prohibitor, 

or that serve as repositories of 

information for NICS reporting 

purposes, are permitted to disclose the 

information needed for these purposes. 

The disclosure is restricted to limited 

demographic and certain other 

information needed for NICS purposes. 

The rule specifically prohibits the 

disclosure of diagnostic or clinical 

information, from medical records or 

other sources, and any mental health 

information beyond the indication that 

the individual is subject to the Federal 

mental health prohibitor. 

DATES: Effective date: This final rule is 

effective on February 5, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Andra Wicks, 202–205–2292. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 16, 2013, President Barack 

Obama announced 23 executive actions 

aimed at curbing gun violence across 

the nation. Those actions include efforts 

by the Federal government to strengthen 

the national background check system, 

and a specific commitment to ‘‘[a]ddress 

unnecessary legal barriers, particularly 

relating to the Health Insurance 

Portability and Accountability Act, that 

may prevent States from making 

information available to the background 

check system.’’ The National Instant 

Criminal Background Check System 

(NICS) is the system used to determine 

whether a potential firearms recipient is 

statutorily prohibited from possessing or 

receiving a firearm. The Department 

proposed, and now finalizes, a 

modification to the HIPAA Privacy Rule 

to permit certain covered entities to 

disclose to the NICS the identities of 

persons who are not allowed to possess 

or receive a firearm because they are 

subject to the Federal mental health 

prohibitor. 

The National Instant Criminal 

Background Check System (NICS) 

The Brady Handgun Violence 

Prevention Act of 1993, Public Law 

103–159 (Brady Gun Law), and its 

implementing regulations, are designed 

to prevent the transfer of firearms by 

licensed dealers to individuals who are 

not allowed to possess or receive them 

as a result of restrictions contained in 

either the Gun Control Act of 1968, as 

amended (Title 18, United States Code, 

Chapter 44), or State law. The Gun 

Control Act identifies several categories 

(known as ‘‘prohibitors’’) of 

individuals 1 who are prohibited from 

engaging in the shipment, transport, 

receipt, or possession of firearms, 

including convicted felons and 

fugitives. Most relevant for the purposes 

of this rule is the Federal mental health 

prohibitor, which, pursuant to 

Department of Justice (DOJ) regulations, 

applies to individuals who have been 

involuntarily committed to a mental 

institution, for reasons such as mental 

illness or drug use; 2 found incompetent 

to stand trial or not guilty by reason of 

insanity; or otherwise determined by a 

court, board, commission, or other 

lawful authority to be a danger to 

themselves or others or unable to 

manage their own affairs, as a result of 

marked subnormal intelligence, or 

mental illness, incompetency, 

condition, or disease.3 4

The Brady Gun Law established the 

NICS to help enforce these prohibitions, 

as well as State law prohibitions on the 

possession or receipt of firearms.5 The 

NICS Index, a database administered by 

the Federal Bureau of Investigation 

(FBI), collects and maintains certain 

identifying information about 

individuals who are subject to one or 

more Federal prohibitors and thus who 

are ineligible to purchase firearms. As of 

2012, the NICS Index also contains 

information on persons who are subject 

to State law prohibitions on the 

possession or receipt of firearms.6 The 


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