This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

7445 

Vol. 81, No. 29 

Friday, February 12, 2016 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 601 

[Docket No. FDA–2015–N–2103] 

Removal of Review and 

Reclassification Procedures for 

Biological Products Licensed Prior to 

July 1, 1972 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is removing two regulations that 

prescribe procedures for FDA’s review 

and classification of biological products 

licensed before July 1, 1972. FDA is 

taking this action because the two 

regulations are obsolete and no longer 

necessary in light of other statutory and 

regulatory authorities established since 

1972, which allow FDA to evaluate and 

monitor the safety and effectiveness of 

all biological products. In addition, 

other statutory and regulatory 

authorities authorize FDA to revoke a 

license for biological products because 

they are not safe and effective, or are 

misbranded. FDA is taking this action as 

part of its retrospective review of its 

regulations to promote improvement 

and innovation. 

DATES: This rule is effective March 14, 

2016. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1062, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jessica T. Walker, 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: 

I. Executive Summary 

A. Purpose of the Final Rule 

FDA is removing two regulations that 

prescribe procedures for FDA’s review 

and classification of biological products 

licensed before July 1, 1972, because the 

two regulations are obsolete and no 

longer necessary in light of other 

statutory and regulatory authorities 

established since 1972. These other 

statutory and regulatory authorities 

allow FDA to evaluate and monitor the 

safety and effectiveness of all biological 

products and authorize FDA to revoke a 

license for products because they are 

not safe and effective, or are 

misbranded. 

B. Summary of the Major Provisions of 

the Final Rule 

The final rule removes §§ 601.25 and 

601.26 (21 CFR 601.25 and 601.26), 

which prescribe procedures for FDA’s 

review and classification of biological 

products licensed before July 1, 1972. 

C. Legal Authority 

FDA is taking this action under the 

biological products provisions of the 

Public Health Service Act (the PHS Act), 

and the drugs and general 

administrative provisions of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act). 

D. Costs and Benefits 

Because this final rule would not 

impose any additional regulatory 

burdens, this regulation is not 

anticipated to result in any compliance 

costs and the economic impact is 

expected to be minimal. 

II. Background 

A. History of the Rulemaking 

In the Federal Register of July 2, 2015 

(80 FR 38145), FDA proposed to remove 

regulations that prescribe procedures for 

FDA’s review and classification of 

biological products licensed before July 

1, 1972. As discussed in the preamble 

to the proposed rule, these regulations 

were originally issued after the Director 

of the National Institutes of Health 

(NIH) announced in the Federal 

Register on March 15, 1972, that the 

Division of Biologics Standards, NIH, 

would review the effectiveness of all 

licensed biologicals (37 FR 5404). In the 

Federal Register of June 29, 1972 (37 FR 

12865), FDA announced the transfer of 

regulatory authority over biological 

products from the Division of Biologics 

Standards, NIH, to FDA. After obtaining 

regulatory authority over biological 

products, the Commissioner of FDA 

proposed procedures for reviewing the 

safety, effectiveness, and labeling of all 

biological products licensed at the time 

of the transfer on July 1, 1972 (37 FR 

16679, August 18, 1972). The 

procedures for review of biological 

products licensed before July 1, 1972, 

were codified in 21 CFR 273.245 (38 FR 

4319 at 4321, February 13, 1973) and 

later redesignated to § 601.25 (38 FR 

32048, November 20, 1973). The 

procedures for review of biological 

products licensed before July 1, 1972, 

were supplemented by procedures 

codified in § 601.26 (47 FR 44062, 

October 5, 1982). 

B. Current Methods for Ensuring the 

Safety and Effectiveness of Biological 

Products 

Since establishing the procedures 

under §§ 601.25 and 601.26, FDA 

developed new regulations to assess and 

ensure the safety and efficacy of 

biological products. FDA issued the 

Current Good Manufacturing Practice 

(cGMP) regulations, which contain the 

minimum cGMP for preparation of drug 

products, including biological products. 

The cGMP regulations help FDA ensure 

that such products meet the 

requirements for product safety, 

effectiveness, and labeling. FDA also 

helps ensure the safety and effectiveness 

of biological products through 

application of other regulations, such as 

the reporting of biological product 

deviations by licensed manufacturers 

(see 21 CFR 600.14), postmarketing 

reporting of adverse experiences (21 

CFR 600.80), and labeling regulations 

(for example, 21 CFR part 201). 

Biological products that do not meet the 

requirements under these regulations 

are subject to license revocation under 

21 CFR 601.5, which allows FDA to 

revoke any biologics license for a 

product that fails to meet applicable 

standards and fails to comply with 


srobinson on DSK5SPTVN1PROD with RULES
7446 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

regulations designed to help ensure the 

safety, purity, and potency of the 

licensed product, and that the product 

is not misbranded. 

In addition, FDA continues to help 

ensure the safety and effectiveness of 

licensed biological products through the 

development and application of 

additional standards and mechanisms. 

These mechanisms assist FDA in 

evaluating and monitoring the safety 

and effectiveness of biological products. 

C. Summary of Comments to the 

Proposed Rule 

FDA did not receive any comments on 

the proposed rule. 

D. General Overview of the Final Rule 

The final rule removes §§ 601.25 and 

601.26 of the regulations, which 

prescribe procedures for FDA’s review 

and classification of biological products 

licensed before July 1, 1972. FDA is 

taking this action because these 

regulations are obsolete and no longer 

necessary in light of other statutory and 

regulatory authorities established since 

1972, which allow FDA to evaluate and 

monitor the safety and effectiveness of 

all biological products. 

III. Legal Authority 

FDA is issuing this regulation under 

the biological products provisions of the 

PHS Act (42 U.S.C. 262 and 264) and 

the drugs and general administrative 

provisions of the FD&C Act (sections 

201, 301, 501, 502, 503, 505, 510, 701, 

and 704 (21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 371, and 374)). Under 

these provisions of the PHS Act and the 

FD&C Act, we have the authority to 

issue and enforce regulations designed 

to ensure that biological products are 

safe, pure, and potent; and to prevent 

the introduction, transmission, and 

spread of communicable disease. 

IV. Economic Analysis of Impacts 

We have examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, 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 Agencies 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). We 

believe that this final rule is not a 

significant regulatory action as defined 

by Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this final rule removes 

regulations that are obsolete and no 

longer necessary in light of other current 

statutory and regulatory authorities, 

FDA certifies that the final 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 issuing ‘‘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 $144 million, using the 

most current (2014) Implicit Price 

Deflator for the Gross Domestic Product. 

This final rule would not result in any 

1-year expenditure that would meet or 

exceed this amount. 

V. Analysis of Environmental Impact 

We have determined under 21 CFR 

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

does not individually or cumulatively 

have a significant adverse effect on the 

human environment. Therefore, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

VI. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

OMB under the Paperwork Reduction 

Act of 1995 is not required. 

VII. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that would 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, the 

Agency has concluded 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. 

List of Subjects in 21 CFR Part 601 

Administrative practice and 

procedure, Biologics, Confidential 

business information. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, 21 CFR part 601 is amended 

as follows: 

PART 601—LICENSING 

■ 1. The authority citation for 21 CFR 

part 601 continues to read as follows: 

Authority: 15 U.S.C. 1451–1561; 21 U.S.C. 

321, 351, 352, 353, 355, 356b, 360, 360c– 

360f, 360h-360j, 371, 374, 379e, 381; 42 

U.S.C. 216, 241, 262, 263, 264; sec 122, 

Pub. L. 105–115, 111 Stat. 2322 (21 U.S.C. 

355 note). 

§ 601.25 [Removed] 

■ 2. Remove § 601.25. 

§ 601.26 [Removed] 

■ 3. Remove § 601.26. 

Dated: February 5, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02884 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 868 and 870 

[Docket No. FDA–2012–N–1174] 

Anesthesiology Devices; 

Reclassification of Membrane Lung for 

Long-Term Pulmonary Support; 

Redesignation as Extracorporeal 

Circuit and Accessories for Long-Term 

Respiratory/Cardiopulmonary Failure 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

order to redesignate membrane lung 

devices for long-term pulmonary 

support, a preamendments class III 

device, as extracorporeal circuit and 

accessories for long-term respiratory/

cardiopulmonary failure, and to 

reclassify the device to class II (special 

controls) in patients with acute 

respiratory failure or acute 

cardiopulmonary failure where other 

available treatment options have failed, 

and continued clinical deterioration is 

expected or the risk of death is 

imminent. A membrane lung device for 

long-term pulmonary support (>6 hours) 

refers to the oxygenator in an 

extracorporeal circuit used during longterm procedures, commonly referred to 


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