Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 64299 

said Order as hereby proposed to be 

amended as follows: 

The provisions of the proposed 

marketing order amending the Order 

contained in the proposed rule issued 

by the Administrator on July 19, 2018, 

and published in the Federal Register 

(83 FR 34953) on July 24, 2018, will be 

and are the terms and provisions of this 

order amending the Order and are set 

forth in full herein. 

List of Subjects in 7 CFR Part 956 

Onions, Marketing agreements, 

Reporting and recordkeeping 

requirements. 

Dated: December 11, 2018. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

For the reasons discussed in the 

preamble, 7 CFR part 956 is proposed to 

be amended as follows. 

PART 956—SWEET ONIONS GROWN 

IN THE WALLA WALLA VALLEY OF 

SOUTHEAST WASHINGTON AND 

NORTHEAST OREGON 

■ 1. The authority citation for 7 CFR 

part 956 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Amend § 956.20 by revising 

paragraph (a) to read as follows: 

§ 956.20 Establishment and membership. 

(a) The Walla Walla Sweet Onion 

Marketing Committee, consisting of 

seven members, is hereby established. 

The Committee shall consist of four 

producer members, two handler 

members, and one public member. Each 

member shall have an alternate who 

shall have the same qualifications as the 

member. 

* * * * * 

■ 3. Revise § 956.21 to read as follows: 

§ 956.21 Term of office. 

(a) Except as otherwise provided in 

paragraph (b) of this section, the term of 

office of grower and handler Committee 

members and their respective alternates 

shall be two fiscal periods beginning on 

June 1 or such other date as 

recommended by the Committee and 

approved by the Secretary. The terms 

shall be determined so that one-half of 

the grower membership and one-half of 

the handler membership shall terminate 

each year. Members and alternates shall 

serve during the term of office for which 

they are selected and have been 

qualified, or during that portion thereof 

beginning on the date on which they 

qualify during such term of office and 

continuing until the end thereof, or 

until their successors are selected and 

have qualified. 

(b) The term of office of the initial 

members and alternates shall begin as 

soon as possible after the effective date 

of this subpart. One-half of the initial 

industry grower and handler members 

and alternates shall serve for a one-year 

term and one-half shall serve for a twoyear term. The initial as well as all 

successive terms of office of the public 

member and alternate member shall be 

for three years. 

(c) The consecutive terms of office for 

all grower and handler members shall 

be limited to two two-year terms. There 

shall be no such limitation for alternate 

members. 

■ 4. Amend § 956.28 by revising 

paragraph (a) to read as follows: 

§ 956.28 Procedure. 

(a) Four members of the Committee 

shall constitute a quorum, and four 

concurring votes shall be required to 

pass any motion or approve any 

Committee action, except that 

recommendations made pursuant to 

§ 956.61 shall require five concurring 

votes. 

* * * * * 

[FR Doc. 2018–27143 Filed 12–13–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 180712626–8840–01] 

RIN 0694–AH61 

Review of Controls for Certain 

Emerging Technologies 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Advance notice of proposed 

rulemaking (ANPRM), Extension of 

comment period. 

SUMMARY: The Bureau of Industry and 

Security (BIS) is extending the comment 

period for its November 19, 2018, 

advanced notice of proposed 

rulemaking (ANPRM), ‘‘Review of 

Controls for Certain Emerging 

Technologies’’ until January 10, 2019. In 

response to requests received from 

members of the public, BIS believes it 

is appropriate to extend the comment 

period to provide interested parties 

additional time to submit their 

responses to the ANPRM. 

DATES: The comment period announced 

in the notice that was published on 

November 19, 2018 (83 FR 58201) is 

extended. Comments on the ANPRM 

must now be received by BIS on or 

before January 10, 2019. 

ADDRESSES: You may submit comments 

through either of the following: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. The identification 

number for this rulemaking is BIS 2018– 

0024. 

• Address: By mail or delivery to 

Regulatory Policy Division, Bureau of 

Industry and Security, U.S. Department 

of Commerce, Room 2099B, 14th Street 

and Pennsylvania Avenue NW, 

Washington, DC 20230. Refer to RIN 

0694–AH61. 

FOR FURTHER INFORMATION CONTACT: 

Kirsten Mortimer, Office of National 

Security and Technology Transfer 

Controls, Bureau of Industry and 

Security, Department of Commerce. 

Phone: (202) 482–0092; Fax (202) 482– 

3355; Email: Kirsten.Mortimer@

bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On November 19, 2018 (83 FR 58201), 

the Bureau of Industry and Security 

(BIS) published an advanced notice of 

proposed rulemaking, ‘‘Review of 

Controls for Certain Emerging 

Technologies,’’ which included a 

comment period deadline of December 

19, 2018. Since publication, BIS has 

received requests for additional time to 

submit comments. In response to those 

requests, BIS is extending the public 

comment period until January 10, 2019. 

A description of the specific topics and 

issues that BIS would like addressed is 

outlined in the November 19, 2018 

Federal Register ANPRM. 

Dated: December 10, 2018. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2018–27148 Filed 12–13–18; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

Withdrawal of Proposed Rule on 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; withdrawal. 


amozie on DSK3GDR082PROD with PROPOSALS1
64300 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the withdrawal of the 

proposed rule on ‘‘Supplemental 

Applications Proposing Labeling 

Changes for Approved Drugs and 

Biological Products’’ that published in 

the Federal Register of November 13, 

2013. FDA is taking this action in light 

of concerns expressed by commenters 

and considerations regarding Agency 

resources. FDA is continuing to 

consider ways to improve the 

communication of important, newly 

acquired drug safety information to 

healthcare providers and the public and 

to facilitate efforts to keep drug product 

labeling up to date throughout the 

product lifecycle. 

DATES: The proposed rule published 

November 13, 2013 (78 FR 67985), is 

withdrawn as of December 14, 2018. 

ADDRESSES: For access to the docket, go 

to https://www.regulations.gov and 

insert the docket number found in 

brackets in the heading of this 

document into the ‘‘Search’’ box and 

follow the prompts, and/or go to the 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Janice L. Weiner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6270, 

Silver Spring, MD 20993–0002, 301– 

796–3601, janice.weiner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Federal Food, Drug, and 

Cosmetic Act, the Public Health Service 

Act, and FDA regulations, the Agency 

makes decisions regarding the approval 

of marketing applications, including 

supplemental applications, based on a 

comprehensive analysis of the product’s 

risks and benefits under the conditions 

of use prescribed, recommended, or 

suggested in the labeling (see 21 U.S.C. 

355(c) and (d); 42 U.S.C. 262). All drugs 

have risks, and healthcare practitioners 

and patients must balance the risks and 

benefits of a drug when making 

decisions about medical therapy. As a 

drug is used more widely or under 

diverse conditions, new information 

regarding the risks and benefits of a 

drug may become available, and may 

include new risks or new information 

about known risks. Accordingly, all 

holders of new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), and biologics 

license applications (BLAs) are required 

to develop written procedures for the 

surveillance, receipt, evaluation, and 

reporting of postmarketing adverse drug 

experiences to FDA (see 21 CFR 

314.80(b), 314.98(a), and 600.80(b)). 

Application holders also must comply 

with applicable reporting and 

recordkeeping requirements, including 

submission of an annual report (which 

contains, among other things, a brief 

summary of significant new information 

from the previous year that might affect 

the safety, effectiveness, or labeling of 

the drug product, and a description of 

the actions the applicant has taken or 

intends to take as a result of this new 

information) and, if appropriate, 

proposed revisions to product labeling 

(see 21 U.S.C. 355(k) and 21 CFR 

314.81). 

When new information becomes 

available that causes labeling to be 

inaccurate, false, or misleading, all drug 

and biological product application 

holders must take steps to change the 

content of their product labeling in 

accordance with §§ 314.70, 314.97, and 

601.12 (21 CFR 314.70, 314.97, and 

601.12) (see 21 CFR 201.56(a)(2); see 

also 21 U.S.C. 331(a) and (b) and 352(a), 

(f), and (j)). While all drug and 

biological product application holders 

have these obligations, under current 

regulations, the procedures available to 

ANDA holders to update the labeling of 

generic drugs differ in certain respects 

from the procedures available to NDA 

holders and BLA holders to update 

product labeling. In addition, there are 

limitations on the procedures available 

to NDA holders and BLA holders to 

make certain updates to the Highlights 

of Prescribing Information of drug and 

biological product labeling that are 

subject to the content and format 

labeling requirements described in 

§§ 201.56(d) and 201.57 (21 CFR 

201.56(d) and 201.57) (commonly 

referred to as the ‘‘Physician Labeling 

Rule’’ (PLR) format). 

In the Federal Register of November 

13, 2013 (78 FR 67985), FDA proposed 

to amend its regulations to revise and 

clarify procedures for application 

holders of an approved drug or 

biological product to change the product 

labeling to reflect certain types of newly 

acquired safety-related information in 

advance of FDA’s review of the change 

by submitting a ‘‘changes being 

effected’’ (CBE–0) supplement to FDA. 

A CBE–0 supplement is an exception to 

the general requirement for FDA 

approval of a prior approval supplement 

containing revised product labeling 

before distribution. The proposed rule, 

if finalized, would have enabled ANDA 

holders for generic drugs to 

independently update and promptly 

distribute revised product labeling to 

reflect certain types of newly acquired 

safety-related information, even though 

the revised labeling may temporarily 

differ from that of the corresponding 

reference listed drug (RLD or brand 

drug) upon submission of a CBE–0 

supplement to FDA. FDA’s proposed 

revisions to its regulations to allow 

generic drug manufacturers to update 

product labeling through CBE–0 

supplements in the same manner as 

brand drug manufacturers were 

intended to improve communication of 

important, newly acquired drug safety 

information to healthcare providers and 

the public. The proposed rule, if 

finalized, also would have removed the 

limitation on submission of CBE–0 

supplements by any application holder 

for certain changes to the Highlights of 

Prescribing Information in PLR-format 

product labeling. For further 

information about these and other 

proposed regulatory changes described 

in the proposed rule, see 78 FR 67985. 

FDA received numerous comments on 

the proposed rule from a diverse group 

of stakeholders. In view of requests to 

meet with FDA to present alternatives to 

the proposed regulatory changes 

described in the proposed rule and to 

promote transparency, FDA held a 

public meeting on March 27, 2015, at 

which any stakeholder had the 

opportunity to present or comment on 

the proposed rule or any alternative 

proposals intended to improve 

communication of important, newly 

acquired drug safety information to 

healthcare professionals and the public. 

In the February 18, 2015, document 

announcing the public meeting (80 FR 

8577), FDA reopened the docket for the 

proposed rule until April 27, 2015, to 

receive submissions of additional 

written comments on the proposed rule 

as well as alternative proposals 

presented during the public meeting. 

Several comments supported 

finalizing the rule as originally 

proposed. Other comments supported 

the goals of the proposed rule, but 

expressed concern that temporary 

labeling differences between generic 

drugs and the corresponding brand drug 

could complicate healthcare decision 

making. Comments in support of the 

proposed rule maintained that it would 

enhance drug safety by making 

healthcare practitioners and the public 

aware of new safety-related information 

about a drug more quickly. Several 

comments also opined that tort liability 

for failure to adequately warn patients 

of a known hazard may be an incentive 

for drug manufacturers to ensure that 

their product labeling reflects the most 

current safety information. 

Comments in opposition to the 

proposed rule raised policy, legal, and 

cost considerations. A number of 


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Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 64301 

comments asserted that generic drug 

application holders do not generally 

receive or possess all the data necessary 

to evaluate postmarket safety 

information and to support safetyrelated labeling changes. Comments 

expressed concern that additional or 

different warnings in generic drug 

labeling, even if temporary, may 

undermine confidence in generic drugs 

and their therapeutic equivalence to the 

brand drug. Comments throughout the 

healthcare delivery system also 

expressed concern about the confusion 

that might result if there were different 

versions of safety labeling for multiple 

generic versions of the same drug until 

FDA decided whether to approve the 

labeling changes proposed in the CBE– 

0 supplements. Several comments 

asserted that the proposed rule would 

impose significant burdens on the 

generic drug industry that would 

necessarily increase the cost of generic 

drugs or lead to market exit, which may 

increase the risk of drug shortages. 

However, most concerns regarding 

economic impact focused on the 

increased risk of tort litigation against 

generic drug manufacturers and others 

in the healthcare system. 

II. Withdrawal of the Proposed Rule 

Having reviewed the comments on the 

proposed rule and further considered 

the proposal, FDA is withdrawing the 

proposed rule on ‘‘Supplemental 

Applications Proposing Labeling 

Changes for Approved Drugs and 

Biological Products’’ published in the 

Federal Register of November 13, 2013. 

The concerns raised in the comments 

reflect significant competing interests, 

and FDA acknowledges that the 

proposed rule, if finalized, would 

present significant potential downsides. 

In light of those potential downsides, 

the Agency does not believe that 

finalizing the proposed rule would be 

an appropriate use of Agency resources. 

Rather, the Agency believes that such 

resources would be better used on other 

efforts to improve the communication of 

important, newly acquired drug safety 

information to healthcare professionals 

and the public, as discussed in greater 

detail below. 

The withdrawal of this proposed rule 

does not alter the ongoing obligation 

under FDA’s current regulations for all 

holders of marketing applications for 

drug and biological products—including 

ANDA holders—to ensure their product 

labeling is accurate, and not false or 

misleading, and to take steps to update 

their product labeling when new 

information becomes available that 

causes the labeling to become 

inaccurate, false, or misleading (see 

§ 201.56(a)(2); see also 21 U.S.C. 331(a) 

and (b) and 352(a), (f), and (j)). This 

obligation serves an important public 

health function because new 

information regarding the risks and 

benefits of a drug may become available 

over time from various sources, 

including from postmarketing adverse 

drug experience reports and published 

literature, and updates to product 

labeling may be necessary. 

In addition to the ongoing obligation 

described above, ANDA holders must 

generally maintain the same labeling as 

the RLD throughout the lifecycle of the 

generic drug product. ANDA holders 

can, however, propose certain updates 

to product labeling by submitting a prior 

approval supplement that contains 

adequate supporting information for the 

proposed change. FDA will determine 

whether the proposed labeling change is 

appropriate, and whether the labeling 

for the RLD and corresponding generic 

drug(s) should be revised. If the 

approval of the NDA for the RLD has 

been withdrawn at the NDA holder’s 

request because the RLD is no longer 

being marketed and certain other 

conditions are satisfied (see 21 CFR 

314.150(c)), the NDA holder can no 

longer update labeling for the 

withdrawn RLD, but ANDA holders can 

still propose labeling updates through 

the submission of a prior approval 

supplement. In such cases, if FDA 

determines that the proposed labeling 

change is appropriate and approves the 

supplement, the Agency may request 

that other ANDA holders and any 

ANDA applicants relying on the same 

withdrawn RLD make the same updates 

(see FDA draft guidance for industry 

‘‘Updating ANDA Labeling After the 

Marketing Application for the Reference 

Listed Drug Has Been Withdrawn,’’ 81 

FR 44883, July 11, 2016) (Draft 

Guidance on Updating ANDA Labeling) 

(Ref. 1). 

As noted, the proposed rule would 

have removed the current prohibition 

against the submission of CBE–0 

supplements by NDA and BLA holders 

to change information in the Highlights 

of Prescribing Information portion of 

drug labeling. If an NDA holder or a 

BLA holder seeks to submit a CBE–0 

supplement to change information in 

the Highlights of Prescribing 

Information to reflect newly acquired 

information for any of the reasons 

described in § 314.70(c)(6)(iii) or 

§ 601.12(f)(2), as applicable, the NDA 

holder or BLA holder can normally 

obtain permission to do so under the 

current regulation by contacting FDA. In 

response to an applicant’s inquiry about 

submission of a CBE–0 supplement for 

a change that would affect the 

Highlights of drug labeling, FDA 

typically waives the limitation on 

submission of a CBE–0 supplement 

under 21 CFR 314.90 or specifically 

requests that the applicant proceed with 

a CBE–0 supplement under 

§ 314.70(c)(6)(iii)(E) or 

§ 601.12(f)(2)(i)(E). 

FDA is continuing to consider ways to 

improve the communication of 

important, newly acquired drug safety 

information to healthcare professionals 

and the public, and to facilitate efforts 

to keep drug product labeling up to date 

throughout the product lifecycle. 

Although the proposed rule focused on 

labeling updates to reflect newly 

acquired information related to drug 

safety, we recognize that there are 

general challenges for keeping generic 

drug labeling up to date when the RLD 

labeling is no longer being updated, 

including when FDA has withdrawn 

approval of the NDA for reasons other 

than safety or effectiveness. The Agency 

is actively evaluating ways to facilitate 

the updating of generic drug labeling to 

help ensure that drug labeling reflects 

the most current information. For 

example, FDA’s fiscal year (FY) 2019 

Budget Request includes an investment 

to support efforts to update generic drug 

labeling, with an initial focus on 

oncology products, as part of the 

Agency’s efforts to ensure that patients 

and their providers have access to upto-date information to inform clinical 

decisions (Ref. 2). These efforts to 

ensure that more generic drugs have upto-date product labeling reflecting the 

latest treatment information can also 

encourage wider adoption of generic 

drugs, broadening access to lower-cost 

alternatives to brand drugs for the 

American people. 

The withdrawal of this proposed rule 

does not preclude the Agency from 

reinstituting rulemaking concerning the 

issues addressed in the proposal. 

Should we decide to undertake such 

rulemaking in the future, we will repropose the action and provide new 

opportunities for comment. 

Furthermore, this proposed rule is only 

intended to address the withdrawal of 

the proposed rule on ‘‘Supplemental 

Applications Proposing Labeling 

Changes for Approved Drugs and 

Biological Products’’ published in the 

Federal Register of November 13, 2013, 

and not any other pending proposals 

that the Agency has issued or is 

considering, including the Draft 

Guidance on Updating ANDA Labeling 

(Ref. 1) or the Agency’s efforts to update 

the labeling of certain oncology drug 

products under FDA’s FY2019 Budget 

Request (Ref. 2). If you need additional 

information about the subject matter of 


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64302 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 

1See the Administrative Simplification 

provisions of title II, subtitle F, of the HIPAA (Pub. 

L. 104–191), which added a new part C to title XI 

of the Social Security Act (sections 1171–1179 of 

the Social Security Act, 42 U.S.C. 1320d–1320d–8) 

and included section 264, under which HHS has 

adopted the HIPAA Privacy Rule. 

2The HITECH Act was enacted as title XIII of 

division A and title IV of division B of the 

American Recovery and Reinvestment Act of 2009 

(ARRA) (Pub. L. 111–5). 

3See the HIPAA Privacy and Security Rules at 45 

CFR part 160 and Subparts A, C, and E of part 164. 

4See 45 CFR part 160 and part 164, Subparts A 

and D. 

the withdrawn proposed rule, you may 

review the Agency’s website (https://

www.fda.gov) for any current 

information on the matter. 

III. References 

The following references are on 

display at the Dockets Management Staff 

(see ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, draft guidance for industry, 

‘‘Updating ANDA Labeling After the 

Marketing Application for the Reference 

Listed Drug Has Been Withdrawn,’’ July 2016 

(available at https://www.fda.gov/ucm/ 

groups/fdagov-public/@fdagov-drugs-gen/ 

documents/document/ucm510240.pdf). 

2. U.S. Department of Health and Human 

Services, Food and Drug Administration, 

‘‘Fiscal Year 2019 Justification of Estimates 

for Appropriations Committees’’ (available at 

https://www.fda.gov/downloads/aboutfda/ 

reportsmanualstorms/reports/budgetreports/ 

ucm603315.pdf). 

Dated: December 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27098 Filed 12–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No.: HHS–OCR–0945–AA00] 

45 CFR Parts 160 and 164 

RIN 0945–AA00 

Request for Information on Modifying 

HIPAA Rules To Improve Coordinated 

Care 

AGENCY: Office for Civil Rights (OCR), 

HHS. 

ACTION: Request for information. 

SUMMARY: The Office for Civil Rights 

(OCR) is issuing this Request for 

Information (RFI) to assist OCR in 

identifying provisions of the Health 

Insurance Portability and 

Accountability Act privacy and security 

regulations that may impede the 

transformation to value-based health 

care or that limit or discourage 

coordinated care among individuals and 

covered entities (including hospitals, 

physicians, and other providers, payors, 

and insurers), without meaningfully 

contributing to the protection of the 

privacy or security of individuals’ 

protected health information. This RFI 

requests information on whether and 

how the rules could be revised to 

promote these goals, while preserving 

and protecting the privacy and security 

of such information and individuals’ 

rights with respect to it. 

DATES: Comments must be submitted on 

or before February 12, 2019. 

ADDRESSES: You may send comments, 

identified by RIN 0945–AA00 or Docket 

HHS–OCR–0945–AA00, by any of the 

following methods: 

• Federal eRulemaking Portal. You 

may submit electronic comments at 

http://www.regulations.gov by searching 

for the Docket ID number HHS–OCR– 

0945–AA00. Follow the instructions for 

sending comments. 

• Hand-Delivery or Regular, Express, 

or Overnight Mail: U.S. Department of 

Health and Human Services, Office for 

Civil Rights, Attention: RFI, RIN 0945– 

AA00, Hubert H. Humphrey Building, 

Room 509F, 200 Independence Avenue 

SW, Washington, DC 20201. 

Instructions: All submissions received 

must include ‘‘Department of Health 

and Human Services, Office for Civil 

Rights RIN 0945–AA00’’ for this RFI. All 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. Further 

instructions are available under PUBLIC 

PARTICIPATION. 

Docket: For complete access to the 

docket to read background documents 

or comments received, go to http://

www.regulations.gov and search for 

Docket ID number HHS–OCR–09454– 

AA00. 

FOR FURTHER INFORMATION CONTACT: 

Marie Meszaros at (800) 368–1019 or 

(800) 537–7697 (TDD). 

SUPPLEMENTARY INFORMATION: 

I. Background 

This RFI seeks public input on the 

regulations issued pursuant to the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 1

and modified pursuant to, among other 

laws, the Health Information 

Technology for Economic and Clinical 

Health (HITECH) Act of 2009.2 The 

HIPAA Privacy and Security Rules 

protect individuals’ medical records and 

other individually identifiable health 

information created or received by or on 

behalf of covered entities, known as 

‘‘protected health information’’ (PHI).3

The Privacy and Security Rules limit the 

circumstances under which covered 

entities may use and disclose PHI and 

require covered entities to implement 

safeguards to protect the privacy and 

security of PHI. The Privacy Rule also 

gives individuals rights with respect to 

their PHI, including the right to access 

their PHI and to receive adequate notice 

of a covered entity’s privacy practices. 

In addition, the HIPAA Breach 

Notification Rule requires HIPAA 

covered entities to provide notification 

following a breach of unsecured PHI to 

individuals and OCR (and, in some 

instances, the media) and requires 

business associates to notify the relevant 

covered entities of such breaches.4 In 

this RFI, the Privacy, Security, and 

Breach Notification Rules will be 

referenced collectively as the HIPAA 

Rules. 

OCR seeks public input on ways to 

modify the HIPAA Rules to remove 

regulatory obstacles and decrease 

regulatory burdens in order to facilitate 

efficient care coordination and/or case 

management and to promote the 

transformation to value-based health 

care, while preserving the privacy and 

security of PHI. Specifically, OCR seeks 

information on the provisions of the 

HIPAA Rules that may present obstacles 

to, or place unnecessary burdens on, the 

ability of covered entities and business 

associates to conduct care coordination 

and/or case management, or that may 

inhibit the transformation of the health 

care system to a value-based health care 

system. Correspondingly, OCR seeks 

comment on modifications to the 

HIPAA Rules that would facilitate 

efficient care coordination and/or case 

management, and/or promote the 

transformation to value-based health 

care. OCR also broadly requests 

information and perspectives from 

regulated entities and the public about 

covered entities’ and business 

associates’ technical capabilities, 

individuals’ interests, and ways to 

achieve these goals. 

In addition, OCR seeks comment on 

aspects of the Privacy Rule that OCR has 

identified for potential modification to 

further these goals, specifically: 

• Promoting information sharing for 

treatment and care coordination and/or 

case management by amending the 

Privacy Rule to encourage, incentivize, 


amozie on DSK3GDR082PROD with PROPOSALS1