82990 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

2-P methyl glycidate (PMK glycidate), 

3,4-MDP-2-P methyl glycidic acid (PMK 

glycidic acid), and alphaphenylacetoacetamide (APAA) in the 

table ‘‘Table of Concentration Limits’’ to 

read as follows: 

§ 1310.12 Exempt chemical mixtures. 

* * * * * 

(c) * * * 

TABLE OF CONCENTRATION LIMITS

DEA 

chemical 

code No. 

Concentration Special conditions 

*******

3,4-MDP-2-P methyl glycidate (PMK glycidate) and 

its optical and geometric isomers.

8535 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

3,4-MDP-2-P methyl glycidic acid (PMK glycidic 

acid) and its salts, optical and geometric isomers, and salts of isomers.

8525 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

alpha-phenylacetoacetamide (APAA) and its optical isomers.8515 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

*******

* * * * * 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–26813 Filed 12–18–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 882 and 1270 

[Docket No. FDA–2020–N–1519] 

RIN 0910–AI41 

Revocation of the Regulations for 

Human Tissue Intended for 

Transplantation and Human Dura 

Mater 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to revoke the 

regulations for human tissue intended 

for transplantation and human dura 

mater recovered prior to May 25, 2005. 

The proposed revocation does not affect 

the regulations for human cells, tissues, 

and cellular and tissue-based products 

(HCT/Ps) recovered on or after May 25, 

2005. FDA is proposing this action 

because these regulations are obsolete or 

no longer necessary to achieve public 

health goals. This action is part of FDA’s 

implementation of Executive Orders 

13771 and 13777. Under these 

Executive Orders, FDA is 

comprehensively reviewing existing 

regulations to identify opportunities for 

repeal, replacement, or modification 

that will result in meaningful burden 

reduction, while allowing the Agency to 

achieve our public health mission and 

fulfill statutory obligations. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 8, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 8, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–N–1519 for ‘‘Revocation of the 

Regulations for Human Tissue Intended 

for Transplantation.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ will be publicly viewable 

at https://www.regulations.gov or at the 

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82991 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, 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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Introduction 

B. Need for Regulation/History of 

Regulation 

C. Applicability of § 882.5975 and Part 

1270 

III. Legal Authority 

IV. Description of the Proposed Rule 

V. Proposed Effective Date 

VI. Preliminary Economic Analysis of 

Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

XI. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA proposes to remove the 

regulations under part 1270 (21 CFR 

part 1270), ‘‘Human Tissue Intended for 

Transplantation’’ and § 882.5975 (21 

CFR 882.5975), ‘‘Human dura mater.’’ 

These regulations apply to certain 

tissues recovered prior to May 25, 2005. 

The Agency does not believe there are 

currently any tissues intended for 

transplantation remaining in inventory 

that were recovered prior to this date 

and that would be subject to these 

regulations. Therefore, the regulations 

under this part are outdated and 

obsolete. All HCT/Ps recovered on or 

after May 25, 2005, are subject to the 

regulations under part 1271 (21 CFR 

part 1271), ‘‘Human Cells, Tissues, and 

Cellular and Tissue-Based Products.’’ 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule would remove part 

1270 ‘‘Human Tissue Intended for 

Transplantation,’’ which applies to 

certain human tissue and to 

establishments or persons engaged in 

the recovery, screening, testing, 

processing, storage, or distribution of 

human tissue. It would also remove 

§ 882.5975, ‘‘Human dura mater,’’ which 

identifies and classifies Human dura 

mater recovered prior to May 25, 2005. 

C. Legal Authority 

FDA is taking this action under the 

communicable disease provisions of the 

Public Health Service Act (the PHS Act) 

and the device provisions of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act). 

D. Costs and Benefits 

Because this proposed rule would not 

impose any additional burden on the 

industry, this regulation is not 

anticipated to result in any compliance 

costs. The costs and cost savings to FDA 

resulting from removing an obsolete 

regulation are expected to be minimal. 

II. Background 

A. Introduction 

On February 24, 2017, Executive 

Order 13777, entitled ‘‘Enforcing the 

Regulatory Reform Agenda’’ (https://

www.federalregister.gov/documents/ 

2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda, 82 FR 12285, 

March 1, 2017) was issued. One of the 

provisions of the Executive Order 

requires Agencies to evaluate existing 

regulations and make recommendations 

to the Agency head regarding their 

repeal, replacement, or modification, 

consistent with applicable law. As part 

of this initiative, FDA is proposing to 

revoke certain regulations as specified 

in this proposed rule. 

B. Need for Regulation/History of 

Rulemaking 

FDA regulates articles containing or 

consisting of human cells or tissues 

intended for implantation, 

transplantation, infusion, or transfer 

into a human recipient. These are 

defined in § 1271.3(d) as HCT/Ps. 

Tissues as defined in § 1270.3(j) 

recovered prior to May 25, 2005, are 

regulated under part 1270. HCT/Ps 

recovered on or after May 25, 2005, are 

subject to the regulations in part 1271. 

Examples of HCT/Ps include, but are 

not limited to the following: bone, 

ligament, skin, cornea, ligament, dura 

mater, heart valve, hematopoietic stem/ 

progenitor cells derived from peripheral 

and cord blood, and semen or other 

reproductive tissue. Vascularized 

human organs for transplantation are 

not considered HCT/Ps. FDA currently 

regulates human dura mater recovered 

prior to May 25, 2005, under § 882.5975. 

In the Federal Register of December 

14, 1993 (58 FR 65514), FDA published 

an interim rule (1993 interim rule) for 

Human Tissue Intended for 

Transplantation. This rule provided 

specific donor suitability and testing 

requirements for certain tissue products. 

As the use of human tissue for 

transplantation increased, FDA 

determined that there was a need for a 

much more comprehensive set of 

regulatory requirements that included a 

broader scope of products. In the 

Federal Register of July 29, 1997 (62 FR 

40429), FDA issued a final rule which 

clarified and modified provisions of the 

1993 interim rule. 

In the Federal Register of March 4, 

1997 (62 FR 9721), FDA announced the 

availability of a document entitled 

‘‘Proposed Approach to the Regulation 

of Cellular and Tissue-Based Products.’’ 

The purpose was to develop a plan to 

address the regulation of human cellular 

and tissue-based products in a more 

comprehensive, but not unduly 

burdensome manner. The plan detailed 

how cellular and tissue-based products 

would be regulated with a tiered 

approach based on risk and the 

necessity for FDA review. 

As part of this approach, FDA 

advanced three regulatory proposals 

including: (1) Registration and Listing; 

(2) Communicable-Disease Screening 

and Testing; and (3) Processing 

Standards. FDA published three final 

rules to implement the proposed 

approach as follows: 

(1) ‘‘Human Cells, Tissues, and 

Cellular and Tissue-Based Products; 

82992 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

Establishment Registration and Listing’’ 

(66 FR 5447, January 19, 2001), which 

set forth part 1271, subpart A (General 

Provisions) and subpart B (Procedures 

for Registration and Listing) (effective 

dates April 4, 2001, and January 21, 

2004 based on the applicability of the 

HCT/P establishment). The final rule 

requires HCT/P establishments to 

register with the Agency and list the 

HCT/Ps they manufacture. 

(2) ‘‘Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products’’ (69 

FR 29786, May 25, 2004), which set 

forth part 1271, subpart C (Donor 

Eligibility) (effective date May 25, 2005). 

The final rule requires HCT/P 

establishments to screen and test cell 

and tissue donors for risk factors for, 

and clinical evidence of, relevant 

communicable disease agents and 

diseases. 

(3) ‘‘Current Good Tissue Practice for 

Human Cell, Tissue, and Cellular and 

Tissue-Based Product Establishments, 

Inspection and Enforcement’’ (69 FR 

68611, November 24, 2004), which set 

forth part 1271, subpart D (Current Good 

Tissue Practice), subpart E (Additional 

Requirements for Establishments 

Described in § 1271.10), and subpart F 

(Inspection and Enforcement of 

Establishments Described in § 1271.10) 

(effective date May 25, 2005). The final 

rule requires HCT/P establishments to 

follow current good tissue practice, 

which governs the methods used in, and 

the facilities and controls used for, the 

manufacture of HCT/Ps; recordkeeping; 

and the establishment of a quality 

program. 

FDA issued these regulations to 

increase the safety of HCT/Ps, and 

public confidence in their safety, by 

helping to prevent the introduction, 

transmission, and spread of 

communicable disease. The regulations 

were issued to protect the public health 

while minimizing regulatory burden, 

which in turn would encourage 

significant innovation. 

C. Applicability of § 882.5975 and Part 

1270 

The Agency did not revoke part 1270 

at the same time the Agency proposed 

part 1271 because it would have been 

impractical to apply part 1271 

retroactively to human tissue, as defined 

in § 1270.3(j), that was recovered before 

the effective date of the final rule. 

Instead, the Agency decided that human 

tissue, as defined in § 1270.3(j), that was 

recovered prior to May 25, 2005, would 

remain subject to the regulations in part 

1270. However, in the final rules 

applicable to HCT/Ps (66 FR 5447 and 

5448; 69 FR 68611), FDA noted its 

intention to revoke part 1270 in the 

future when we were confident that 

there was no human tissue regulated 

under part 1270 available for use. 

Part 1270 applies only to human 

tissue defined in § 1270.3(j) and 

recovered prior to May 25, 2005. The 

device classification set forth in 21 CFR 

882.5975, ‘‘Human dura mater,’’ is only 

applicable to human dura mater 

recovered prior to May 25, 2005. Human 

dura mater recovered on or after May 

25, 2005, is subject to the regulations in 

part 1271 when an establishment does 

not qualify for any of the exceptions in 

§ 1271.15. Further, human dura mater is 

regulated solely under section 361 of the 

PHS Act and part 1271 when the HCT/ 

P meets all the criteria set out in 

§ 1271.10(a). Otherwise the HCT/P is 

regulated as a drug, device, and/or 

biological product under the FD&C Act, 

and/or section 351 of the PHS Act, and 

applicable regulations, including part 

1271. 

Products that meet the definition of 

an HCT/P in § 1271.3(d) that are 

recovered on or after May 25, 2005, 

including those that have been regulated 

after May 25, 2005, as drugs, devices, 

and/or biological products under 

section 351 of the PHS Act and/or the 

FD&C Act will not be affected by 

revocation of part 1270. 

We do not believe there are currently 

any tissues intended for transplantation 

remaining in inventory that were 

recovered prior to May 25, 2005, that 

would be subject to these regulations. 

Therefore, the regulations under 

§ 882.5975 and part 1270 are outdated 

and obsolete. 

III. Legal Authority 

FDA is issuing this proposed rule 

under the communicable disease 

provisions of the PHS Act, which 

provide FDA with the authority to issue 

and enforce regulations designed to 

prevent the introduction, transmission, 

and spread of communicable disease (42 

U.S.C. 216, 243, 264, 271), and 

provisions of the FD&C Act applicable 

to devices (21 U.S.C. 351, 360, 360c, 

360e, 360j, 360l, 371)). 

IV. Description of the Proposed Rule 

Part 1270 became effective in 1997, 

and applies only to human tissue 

defined in § 1270.3(j) and recovered 

prior to May 25, 2005. It is highly 

unlikely there is any human tissue 

regulated under part 1270 remaining in 

inventory today that is suitable for 

human transplantation. This regulation 

is outdated and has been replaced with 

part 1271. 

V. Proposed Effective Date 

FDA is proposing that any final rule 

based on the proposed rule become 

effective 30 days after the date of its 

publication in the Federal Register. 

VI. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 13771, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct us to assess all 

costs and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). Executive Order 

13771 requires that the costs associated 

with significant new regulations ‘‘shall, 

to the extent permitted by law, be offset 

by the elimination of existing costs 

associated with at least two prior 

regulations.’’ We believe that this 

proposed rule is not a significant 

regulatory action as defined by 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the proposed rule, if finalized, 

would not create new regulatory 

responsibilities for small entities, we 

propose to certify that the proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $156 million, 

using the most current (2019) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

This proposed rule, if finalized, 

would remove the obsolete regulations 

under part 1270 for human tissue 

intended for transplantation into a 

human recipient and § 882.5975 for 

human dura matter. These regulations 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82993 

only apply to tissue derived from a 

human body and recovered prior to May 

25, 2005. We believe it is highly 

unlikely any such human tissues remain 

available for use today. The proposed 

rule therefore is not anticipated to result 

in any compliance costs to the industry. 

We expect the economic impact on the 

FDA resulting from removing an 

obsolete regulation to be minimal. 

Table 1 summarizes the estimated 

benefits and costs of the proposed rule, 

if finalized. Annualized over 10 years, 

the estimated benefits (i.e., cost savings) 

of the proposed rule would be $0 at both 

the 3 and 7 percent discount rate. The 

present value of the estimated benefits 

(i.e., cost savings) of the proposed rule 

would also be $0 at both the 3 and 7 

percent discount rate. The annualized 

costs of the proposed rule, if finalized, 

would be $0 at both 3 and 7 percent 

discount rate. The present value of costs 

of the proposed rule would also be $0 

at both 3 and 7 percent discount rate. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

ollars 

Discount 

rate 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year ............................................ $0 $0 $0 2019 7 10 

0 0 0 2019 3 10 

Annualized Quantified ...................................................................

Qualitative ...................................................................................... Field investigators would no longer 

need to reference the obsolete 

regulations, resulting in very minor 

cost savings for FDA in terms of 

employee time. 

Costs: 

Annualized Monetized millions/year .............................................. 0 0 0 2019 7 10 

0 0 0 2019 3 10 

Annualized Quantified ................................................................... .................. .................. .................. .................. 7 

3 

Qualitative ......................................................................................

Transfers: 

Federal Annualized Monetized millions/year ................................ .................. .................. .................. .................. 7 

3 

From/To ......................................................................................... From: To: 

Other Annualized Monetized millions/year .................................... .................. .................. .................. .................. 7 

3 

From/To ......................................................................................... From: To: 

Effects: 

State, Local or Tribal Government: None. 

Small Business: None. 

Wages: None. 

Growth: None. 

In line with Executive Order 13771, in 

table 2 we estimate present and 

annualized values of costs and cost 

savings over an infinite time horizon. 

The present value of the net costs and 

cost savings would be $0 at both 3 and 

7 percent discount rate. 

TABLE 2—EXECUTIVE ORDER 13771 SUMMARY TABLE

[In $ millions 2016 dollars, over an infinite time horizon] 

Item 

Primary 

estimate 

(7%) 

Lower 

estimate 

(7%) 

Upper 

estimate 

(7%) 

Primary 

estimate 

(3%) 

Lower 

estimate 

(3%) 

Upper 

estimate 

(3%) 

Present Value of Costs ............................ $0 $0 $0 $0 $0 $0 

Present Value of Cost Savings ................ 0 0 0 0 0 0 

Present Value of Net Costs ..................... 0 0 0 0 0 0 

Annualized Costs ..................................... 0 0 0 0 0 0 

Annualized Cost Savings ......................... 0 0 0 0 0 0 

Annualized Net Costs .............................. 0 0 0 0 0 0 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 1) and https://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

Reports/EconomicAnalyses/default.htm. 

82994 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.31(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paper Reduction Act of 1995 is not 

required. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule 

does not contain policies that 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. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XI. References 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Preliminary Regulatory Impact 

Analysis; Initial Regulatory Flexibility 

Analysis; Unfunded Mandates Reform Act 

Analysis, Revocation of the Regulations for 

Human Tissue Intended for Transplantation; 

Proposed Rule’’ dated March 24, 2020. Also 

available at: https://www.fda.gov/about-fda/ 

reports/economic-impact-analyses-fdaregulations. 

List of Subjects 

21 CFR Part 882 

Medical devices, Neurological 

devices. 

21 CFR Part 1270 

Communicable diseases, HIV/AIDS, 

Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, it is proposed that 

21 CFR parts 882 and 1270 are amended 

as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for part 882 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

§ 882.5975 [Removed] 

■ 2. Remove § 882.5975. 

PART 1270—[REMOVED] 

■ 3. Under the authority of 42 U.S.C. 

216, 243, 264, 271, 21 CFR part 1270 is 

removed. 

Dated: December 2, 2020. 

Stephen M. Hahn, 

Commissioner of Food and Drugs. 

Dated: December 11, 2020 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–27828 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF EDUCATION 

34 CFR Part 300 

[Docket ID ED–2020–OSERS–0191] 

Proposed Guidance; Questions and 

Answers on Serving Children With 

Disabilities Placed by Their Parents in 

Private Schools 

AGENCY: Office of Special Education and 

Rehabilitative Services, Department of 

Education. 

ACTION: Notice of proposed guidance. 

SUMMARY: The U.S. Department of 

Education (Department) seeks public 

comment on proposed guidance that 

addresses State and local 

responsibilities under Part B of the 

Individuals with Disabilities Education 

Act (IDEA) for providing equitable 

services to parentally placed private 

school children with disabilities. The 

proposed guidance updates and 

supersedes the Department’s guidance 

titled Questions and Answers on 

Serving Children with Disabilities 

Placed by Their Parents in Private 

Schools issued in April 2011. 

DATES: We must receive your comments 

on or before January 20, 2021. 

ADDRESSES: Submit your comments 

through the Federal eRulemaking Portal. 

We will not accept comments submitted 

by mail, fax, or by email or those 

submitted after the comment period. To 

ensure that we do not receive duplicate 

copies, please submit your comments 

only once. In addition, please include 

the Docket ID at the top of your 

comments. 

• Federal eRulemaking Portal: Go to 

www.regulations.gov to submit your 

comments electronically. Information 

on using Regulations.gov, including 

instructions for accessing agency 

documents, submitting comments, and 

viewing the docket, is available on the 

site under ‘‘Help.’’ 

Privacy Note: The Department’s 

policy is to make all comments received 

from members of the public available for 

public viewing in their entirety on the 

Federal eRulemaking Portal at 

www.regulations.gov. Therefore, 

commenters should be careful to 

include in their comments only 

information that they wish to make 

publicly available. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Walawender, U.S. Department 

of Education, 400 Maryland Avenue 

SW, Room 5145, Washington, DC 

20202–5076. Telephone: (202) 245– 

7399. Email: Rebecca.Walawender@

ed.gov. 

SUPPLEMENTARY INFORMATION: 

Invitation to Comment: We invite you 

to submit comments on the proposed 

guidance. See ADDRESSES for 

instructions on how to submit 

comments. 

Assistance to Individuals with 

Disabilities in Reviewing the Record: On 

request, we will provide an appropriate 

accommodation or auxiliary aid to an 

individual with a disability who needs 

assistance to review the comments or 

other documents in the public record for 

the proposed guidance. If you want to 

schedule an appointment for this type of 

aid, please contact the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

Background: The Department 

describes the background for the 

proposed guidance, and our reasons for