Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 2759 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This draft guidance is 

not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). Any 

collection of information, including a 

firm’s public warning (§ 7.42(b)(2)), has 

been approved under OMB control 

number 0910–0249. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Safety/Recalls/ 

default.htm or https://

www.regulations.gov. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00918 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Parts 1 and 42 

[Docket No.: PTO–P–2017–0034] 

RIN 0651–AD25 

Changes To Eliminate Unnecessary 

Regulations 

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO or Office) 

proposes to remove its regulations 

governing reservation clauses, petitions 

from the refusal of a primary examiner 

to admit an amendment, the publication 

of amendments to the regulations, and 

limits that the Director can impose on 

the number of inter partes reviews and 

post-grant reviews heard by the Patent 

Trial and Appeal Board. These 

regulations are unnecessary or 

superfluous and in some cases have 

expired, and their removal will help 

streamline USPTO’s body of regulations 

without reducing the availability of 

services for the public. This proposed 

rule arises out of the USPTO’s work 

during FY 2017 to identify and propose 

regulations for removal, modification, 

and streamlining because they are 

outdated, unnecessary, ineffective, 

costly, or unduly burdensome on the 

agency or the private sector. The 

revisions proposed herein would put 

into effect the work the USPTO has 

done, in part through its participation in 

the Regulatory Reform Task Force 

established by the Department of 

Commerce pursuant to Executive Order 

13777, to review and identify 

regulations that are candidates for 

removal. 

DATES: Written comments must be 

received on or before February 20, 2018. 

ADDRESSES: Comments on the changes 

set forth in this proposed rulemaking 

should be sent by electronic mail 

message to: AD25.comments@uspto.gov. 

Comments may also be submitted by 

postal mail addressed to: Mail Stop 

Comments—Patents, Commissioner for 

Patents, P.O. Box 1450, Alexandria, VA, 

22313–1450, marked to the attention of 

Raul Tamayo, Senior Legal Advisor, 

Office of Patent Legal Administration. 

Comments concerning ideas to improve, 

revise, and streamline other USPTO 

regulations, not discussed in this 

proposed rulemaking, should be 

submitted to: RegulatoryReformGroup@

uspto.gov. 

Comments may also be submitted via 

the Federal eRulemaking Portal at 

http://www.regulations.gov. See the 

Federal eRulemaking Portal website for 

additional instructions on providing 

comments via the Federal eRulemaking 

Portal. Although comments may be 

submitted by postal mail, the Office 

prefers to receive comments by 

electronic mail message over the 

internet because the Office may easily 

share such comments with the public. 

Electronic comments are preferred to be 

submitted in plain text, but also may be 

submitted in ADOBE® portable 

document format or MICROSOFT 

WORD® format. Comments not 

submitted electronically should be 

submitted on paper in a format that 

facilitates convenient digital scanning 

into ADOBE® portable document 

format. 

The comments will be available for 

public inspection at the Office of the 

Commissioner for Patents, currently 

located in Madison East, 600 Dulany 

Street, Alexandria, Virginia. Comments 

also will be available for viewing via the 

Office’s internet website (http://

www.uspto.gov) and at http://

www.regulations.gov. Because 

comments will be made available for 

public inspection, information that the 

submitter does not desire to make 

public, such as an address or phone 

number, should not be included in the 

comments. 

FOR FURTHER INFORMATION CONTACT: Raul 

Tamayo, Senior Legal Advisor, Office of 

Patent Legal Administration, at (571) 

272–7728, for questions regarding the 

changes to 37 CFR 1.79 and/or 1.127; 

Susan L. C. Mitchell, Lead 

Administrative Patent Judge, Patent 

Trial and Appeal Board, at (571) 272– 

8715, for questions regarding the 

changes to 37 CFR part 42; and Nicolas 

Oettinger, Senior Counsel for Regulatory 

and Legislative Affairs, Office of the 

General Counsel, at (571) 272–7832, for 

questions regarding the change to 37 

CFR 1.351 and general questions 

regarding regulatory reform. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with Executive Order 

13777, ‘‘Enforcing the Regulatory 

Reform Agenda,’’ the Department of 

Commerce established a Regulatory 

Reform Task Force (Task Force), 

comprising, among others, agency 

officials from the National Oceanic and 

Atmospheric Administration, the 

Bureau of Industry and Security, and 

the USPTO, and charged the Task Force 

with evaluating existing regulations and 

identifying those that should be 

repealed, replaced, or modified because 

they are potentially outdated, 

unnecessary, ineffective, costly, or 

unduly burdensome to both government 

and private sector operations. 

To support its regulatory reform 

efforts on the Task Force, the USPTO 

assembled a Working Group on 

Regulatory Reform (Working Group), 

consisting of subject matter experts from 

each of the business units that 

implement the USPTO’s regulations, to 

consider, review, and recommend ways 

that the regulations could be improved, 

revised, and streamlined. In considering 

the revisions, the USPTO, through its 

Working Group, incorporated into its 

analyses all presidential directives 

relating to regulatory reform. The 

Working Group reviewed existing 

regulations, both discretionary and 

required by statute or judicial order. The 

USPTO also solicited comments from 

stakeholders through a web page 

established to provide information on 

the USPTO’s regulatory reform efforts, 

and through the Department’s Federal 

Register Notice titled ‘‘Impact of Federal 

Regulations on Domestic 

Manufacturing’’ (82 FR 12786, Mar. 7, 

2017), which addressed the impact of 

regulatory burdens on domestic 

manufacturing. These efforts led to the 

development of candidate regulations 

for removal based on the USPTO’s 

assessment that these regulations were 

not needed and/or that elimination 


daltland on DSKBBV9HB2PROD with PROPOSALS
2760 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 

could improve the USPTO’s body of 

regulations. To facilitate review and 

public comment, the USPTO 

consolidates and proposes in this rule 

revisions to patent regulations in Part 1 

and Patent Trial and Appeal Board 

regulations in Part 42. Other proposals 

to remove regulations on other subject 

areas may be published separately. 

II. Regulations Proposed for Removal 

This proposed rulemaking would 

remove regulations concerning 

reservation clauses, petitions from the 

refusal of a primary examiner to admit 

an amendment, and publication of 

amendments to the regulations in 37 

CFR part 1. This proposed rulemaking 

would also remove regulations 

concerning limits that the Director can 

impose on the number of inter partes 

reviews and post-grant reviews in 37 

CFR part 42. 

In particular, this proposed 

rulemaking would remove 37 CFR 1.79. 

Section 1.79 prohibits reservation 

clauses, i.e., it prohibits a pending 

patent application from containing a 

reservation for a future patent 

application of subject matter disclosed 

but not claimed in the pending 

application. An applicant’s ability to 

claim benefit of a prior application is 

affirmatively provided elsewhere in 

statute and regulation (as described 

below), and the explicit prohibition of 

§ 1.79 on reservation clauses (which do 

not confer this benefit) dates from a time 

when the mechanism for properly 

claiming benefit of a prior application 

was less clear and less fully developed 

in USPTO’s regulations and guidance. 

The proposed removal of § 1.79 is not an 

endorsement of reservation clauses nor 

an invitation for applicants to include 

reservation clauses in applications. The 

Office does not expect the use of 

reservation clauses to significantly 

increase once the proposed rulemaking 

is made final, because such reservation 

clauses provide no legal benefit, 

regardless of § 1.79. For example, the 

inclusion of a reservation clause in a 

pending application would not change 

any of the requirements for a future 

application to benefit from the earlier 

filing date of the pending application. 

The authority for the future application 

to benefit from the earlier filing date of 

the pending application would stem, as 

it does now, from the fulfillment of 

requirements set forth in statutory and 

regulatory provisions in which a 

reservation clause plays no role, e.g., 35 

U.S.C. 120 and 37 CFR 1.78. Nor would 

the inclusion of a reservation clause 

protect against rejections for statutory or 

nonstatutory double patenting. In view 

of the fact that the inclusion of a 

reservation clause provides no legal 

benefit, and given that the affirmative 

ability to claim benefit of a prior 

application is more fully and 

completely described elsewhere in 

USPTO’s regulations and guidance 

(unlike when § 1.79 was first adopted), 

the prohibition of reservation clauses in 

§ 1.79 is unnecessary. 

Section 1.79 also permits a patent 

application disclosing unclaimed 

subject matter to contain a reference to 

a later filed application of the same 

applicant or owned by a common 

assignee disclosing and claiming that 

subject matter. This provision of § 1.79 

is duplicative and therefore 

unnecessary. 37 CFR 1.78 provides for 

cross-references to other applications, 

including cross-references to 

applications for which a benefit is not 

claimed, which encompasses the later 

filed applications identified in § 1.79. 

Thus, once the proposed rulemaking is 

made final, applicants will continue to 

be able to include in a pending 

application a reference to a later filed 

application as currently provided for in 

§ 1.79. 

This proposed rulemaking would 

remove § 1.127, which also is 

duplicative. Section 1.127 indicates that 

a petition to the Director under 37 CFR 

1.181 may be filed upon a refusal by a 

primary examiner to admit an 

amendment, in whole or in part. Section 

1.127 is unnecessary. The language of 

§ 1.181 makes clear that a refusal by a 

primary examiner to admit an 

amendment is petitionable under 

§ 1.181. The Manual of Patent 

Examining Procedure (9th ed. 2014) 

(Rev. Nov. 2015) also makes this fact 

clear in its discussion at section 

1002.02(c). Thus, once the proposed 

rulemaking is made final, applicants 

will continue to be able to petition 

under § 1.181 the refusal by a primary 

examiner to admit an amendment, in 

whole or in part. 

This proposed rulemaking 

additionally would remove 37 CFR 

1.351. Section 1.351 states that all 

amendments to the regulations in 37 

CFR part 1 will be published in the 

Official Gazette and in the Federal 

Register. Section 1.351 is unnecessary. 

In accordance with the requirements of 

the Administrative Procedure Act (APA) 

and guidance from the Office of 

Management and Budget (OMB), the 

Office publishes any amendments to 37 

CFR part 1 in the Federal Register. The 

APA generally requires the Office to 

give public notice of any regulatory 

change, and OMB’s guidance with 

respect to rulemaking makes clear that 

publication in the Federal Register is 

the required means for giving public 

notice. Furthermore, the Office intends 

to continue publishing all amendments 

to the regulations in 37 CFR part 1 in 

the Official Gazette. Thus, once the 

proposed rulemaking is made final, the 

Office will continue the practice of 

publishing all amendments to the 

regulations in 37 CFR part 1 in the 

Federal Register, as required by OMB, 

and in the Official Gazette. 

Finally, this proposed rulemaking 

would remove 37 CFR 42.102(b) and 

42.202(b), both of which are now out of 

date. Section 42.102(b) provides that the 

Director may impose a limit on the 

number of inter partes reviews that may 

be instituted during each of the first four 

one-year periods that the Leahy-Smith 

America Invents Act (AIA) is in effect. 

Section 42.202(b) has a similar 

provision for post-grant reviews. Neither 

rule remains necessary because the 

fourth anniversary of the effective date 

of the AIA has passed. 

The regulations proposed in this rule 

for removal achieve the objective of 

making the USPTO’s regulations more 

streamlined and less burdensome, while 

enabling the USPTO to fulfill its 

mission goals. The USPTO’s analysis 

shows that removal of these regulations 

is not expected to substantially reduce 

the burden on the impacted community; 

however, the regulations are 

nonetheless being eliminated because 

they are ‘‘outdated, unnecessary, or 

ineffective’’ regulations encompassed by 

the directives in Executive Order 13777. 

III. Discussion of Proposed Rules 

Changes 

Part 1 

Section 1.79: Section 1.79 is removed 

and reserved. 

Section 1.127: Section 1.127 is 

removed and reserved. 

Section 1.351: Section 1.351 is 

removed and reserved. 

Part 42 

Section 42.102(b): Section 42.102(b) is 

removed and reserved. 

Section 42.202(b): Section 42.202(b) is 

removed and reserved. 

Rulemaking Considerations 

A. Administrative Procedure Act: The 

changes in this proposed rulemaking 

involve rules of agency practice and 

procedure, and/or interpretive rules. See 

Perez v. Mortg. Bankers Ass’n, 135 S. Ct. 

1199, 1204 (2015) (Interpretive rules 

‘‘advise the public of the agency’s 

construction of the statutes and rules 

which it administers.’’ (citation and 

internal quotation marks omitted)); Nat’l 

Org. of Veterans’ Advocates v. Sec’y of 

Veterans Affairs, 260 F.3d 1365, 1375 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 2761 

(Fed. Cir. 2001) (Rule that clarifies 

interpretation of a statute is 

interpretive.); Bachow Commc’ns Inc. v. 

FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) 

(Rules governing an application process 

are procedural under the Administrative 

Procedure Act.); Inova Alexandria Hosp. 

v. Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (Rules for handling appeals were 

procedural where they did not change 

the substantive standard for reviewing 

claims.). 

Accordingly, prior notice and 

opportunity for public comment for the 

changes in this proposed rulemaking are 

not required pursuant to 5 U.S.C. 553(b) 

or (c), or any other law. See Perez, 135 

S. Ct. at 1206 (Notice-and-comment 

procedures are required neither when 

an agency ‘‘issue[s] an initial 

interpretive rule’’ nor ‘‘when it amends 

or repeals that interpretive rule.’’); 

Cooper Techs. Co. v. Dudas, 536 F.3d 

1330, 1336–37 (Fed. Cir. 2008) (stating 

that 5 U.S.C. 553, and thus 35 U.S.C. 

2(b)(2)(B), does not require notice and 

comment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’ (quoting 5 U.S.C. 

553(b)(A))). The Office, however, is 

publishing these proposed changes for 

comment as it seeks the benefit of the 

public’s views on the Office’s proposed 

implementation of the proposed rule 

changes. 

B. Regulatory Flexibility Act: For the 

reasons set forth herein, Senior Counsel 

for Regulatory and Legislative Affairs, 

Office of General Law, of the USPTO, 

has certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration that changes proposed 

in this notice will not have a significant 

economic impact on a substantial 

number of small entities. See 5 U.S.C. 

605(b). 

This proposed rule would remove the 

provisions at 37 CFR 1.79, concerning 

the prohibition of reservation clauses, 

§ 1.127, concerning petitions from 

refusal to admit amendment, and 

§ 1.351, concerning the publication of 

amendments to rules. These regulations 

are removed because they are not 

necessary. This rule would also remove 

37 CFR 42.102(b) and 42.202(b), which 

provide that the Director may impose a 

limit on the number of inter partes 

reviews and post-grant reviews that may 

be instituted during each of the first four 

one-year periods that the AIA is in 

effect. These regulations are no longer 

necessary because the fourth 

anniversary of the effective date of the 

AIA has passed. 

Removing these regulations achieves 

the objective of making the USPTO’s 

regulations more effective and more 

streamlined, while enabling the USPTO 

to fulfill its mission goals. The removal 

of these regulations is not expected to 

substantively impact parties as parties 

would either continue to be able to take 

the same action under a different 

regulatory provision, or the rights or 

obligations of the parties would not be 

changed in any way. For these reasons, 

this rulemaking will not have a 

significant economic impact on a 

substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866. 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

Office has complied with Executive 

Order 13563. Specifically, the Office 

has, to the extent feasible and 

applicable: (1) Made a reasoned 

determination that the benefits justify 

the costs of the rule; (2) tailored the rule 

to impose the least burden on society 

consistent with obtaining the regulatory 

objectives; (3) selected a regulatory 

approach that maximizes net benefits; 

(4) specified performance objectives; (5) 

identified and assessed available 

alternatives; (6) involved the public in 

an open exchange of information and 

perspectives among experts in relevant 

disciplines, affected stakeholders in the 

private sector and the public as a whole, 

and provided on-line access to the 

rulemaking docket; (7) attempted to 

promote coordination, simplification, 

and harmonization across government 

agencies and identified goals designed 

to promote innovation; (8) considered 

approaches that reduce burdens and 

maintain flexibility and freedom of 

choice for the public; and (9) ensured 

the objectivity of scientific and 

technological information and 

processes. 

E. Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs): This proposed rule is expected to 

be an Executive Order 13771 

deregulatory action. 

F. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

G. Executive Order 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) Have substantial direct effects on one 

or more Indian tribes; (2) impose 

substantial direct compliance costs on 

Indian tribal governments; or (3) 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

H. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

I. Executive Order 12988 (Civil Justice 

Reform): This rulemaking meets 

applicable standards to minimize 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

J. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

K. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not affect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

L. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule, the USPTO will 

submit a report containing the final rule 

and other required information to the 

United States Senate, the United States 

House of Representatives, and the 

Comptroller General of the Government 

Accountability Office. The changes in 

this notice are not expected to result in 

an annual effect on the economy of 100 

million dollars or more, a major increase 

in costs or prices, or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

the ability of United States-based 

enterprises to compete with foreignbased enterprises in domestic and 

export markets. Therefore, this notice is 

not expected to result in a ‘‘major rule’’ 

as defined in 5 U.S.C. 804(2). 

M. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

notice do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

of 100 million dollars (as adjusted) or 

more in any one year, or a Federal 

private sector mandate that will result 

in the expenditure by the private sector 

of 100 million dollars (as adjusted) or 

more in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions are 


daltland on DSKBBV9HB2PROD with PROPOSALS
2762 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995. See 2 U.S.C. 1501 et seq. 

N. National Environmental Policy 

Act: This rulemaking will not have any 

effect on the quality of the environment 

and is thus categorically excluded from 

review under the National 

Environmental Policy Act of 1969. See 

42 U.S.C. 4321 et seq. 

O. National Technology Transfer and 

Advancement Act: The requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) are not 

applicable because this rulemaking does 

not contain provisions that involve the 

use of technical standards. 

P. Paperwork Reduction Act: The 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.) requires that the 

Office consider the impact of paperwork 

and other information collection 

burdens imposed on the public. This 

rulemaking does not involve an 

information collection that is subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3549). 

Notwithstanding any other provision 

of law, no person is required to respond 

to nor shall a person be subject to a 

penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information displays a currently valid 

OMB control number. 

List of Subjects 

37 CFR Part 1 

Administrative practice and 

procedure, Courts, Freedom of 

Information, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

37 CFR Part 42 

Administrative practice and 

procedure, Inventions and patents. 

For the reasons stated in the 

preamble, the Office proposes to amend 

parts 1 and 42 of title 37 as follows: 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2). 

§ 1.79 [Removed and reserved] 

■ 2. Section 1.79 is removed and 

reserved. 

§ 1.127 [Removed and reserved] 

■ 3. Section 1.127 is removed and 

reserved. 

§ 1.351 [Removed and reserved] 

■ 4. Section 1.351 is removed and 

reserved. 

PART 42—TRIAL PRACTICE BEFORE 

THE PATENT TRIAL AND APPEAL 

BOARD 

■ 5. The authority citation for part 42 

continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 

135, 311, 312, 316, 321–326 and Public Law 

112–29, 125 Stat. 284; and Pub. L. 112–274, 

126 Stat. 2456. 

§ 42.102 [Amended] 

■ 6. Amend § 42.102 by removing and 

reserving paragraph (b). 

§ 42.202 [Amended] 

■ 7. Amend § 42.202 by removing and 

reserving paragraph (b). 

Dated: January 11, 2018. 

Joseph Matal, 

Associate Solicitor, performing the functions 

and duties of the Under Secretary of 

Commerce for Intellectual Property and 

Director of the United States Patent and 

Trademark Office. 

[FR Doc. 2018–00769 Filed 1–18–18; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 1 

RIN 2900–AP90 

Consent for Release of VA Medical 

Records 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend its 

regulations to clarify that a valid 

consent authorizing the Department to 

release the patient’s confidential VA 

medical records to a health information 

exchange (HIE) community partner may 

be established not only by VA’s physical 

possession of the written consent form, 

but also by the HIE community partner’s 

written (electronic) attestation that the 

patient has, in fact, provided such 

consent. This proposed rule would be a 

reinterpretation of an existing, longstanding regulation and is necessary to 

facilitate modern requirements for the 

sharing of patient records with 

community health care providers, 

health plans, governmental agencies, 

and other entities participating in 

electronic HIEs. This revision would 

ensure that more community health care 

providers and other HIE community 

partners can deliver informed medical 

care to patients by having access to the 

patient’s VA medical records at the 

point of care. 

DATES: Comment Date: Comments must 

be received on or before March 20, 2018. 

ADDRESSES: Written comments may be 

submitted through 

www.Regulations.gov; by mail or handdelivery to Director, Regulation Policy 

and Management (00REG), Department 

of Veterans Affairs, 810 Vermont 

Avenue NW, Room 1063B, Washington, 

DC 20420; or by fax to (202) 273–9026. 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AP90 Consent for Release of VA 

Medical Records.’’ Copies of comments 

received will be available for public 

inspection in the Office of Regulation 

Policy and Management, Room 1063B, 

between the hours of 8:00 a.m. and 4:30 

p.m., Monday through Friday (except 

holidays). Please call (202) 461–4902 for 

an appointment. (This is not a toll-free 

number.) In addition, during the 

comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Stephania Griffin, Director, Veterans 

Health Administration Information 

Access and Privacy Office, Department 

of Veterans Affairs, 810 Vermont 

Avenue NW, Washington, DC 20420; 

Stephania.griffin@va.gov, (704) 245– 

2492 (This is not a toll-free number.) 

SUPPLEMENTARY INFORMATION: Under 38 

U.S.C. 7332, VA must keep confidential 

all records of identity, diagnosis, 

prognosis, or treatment of a patient in 

connection with any program or activity 

carried out by VA related to drug abuse, 

alcoholism or alcohol abuse, infection 

with human immunodeficiency virus, or 

sickle cell anemia, and must obtain 

patients’ written consent before VA may 

disclose the protected information 

unless authorized by the statute. This 

requirement applies to communications 

between VA and community health care 

providers for the purposes of treatment, 

except in certain situations, for instance 

in medical emergencies and when the 

records are sent to a non-Department 

entity that provides hospital care to 

patients as authorized by the Secretary. 

38 U.S.C. 7332(b)(2)(A) and (H); Public 

Law 115–26 (April 19, 2017). Although 

section 7332 does not explicitly require 

that the written consent physically be in 

VA’s possession at the time of the 

disclosure, VA had interpreted the 

statute to require such possession, and 

therefore applied 38 CFR 1.475 

consistent with that interpretation. VA 

has reexamined that statutory 

interpretation in light of contemporary 


daltland on DSKBBV9HB2PROD with PROPOSALS