81 FR 7445 - Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

Page Range		7445-7446
FR Document		2016-02884

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.

Federal Register, Volume 81 Issue 29 (Friday, February 12, 2016)

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7445-7446]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02884]



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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / 
Rules and Regulations

[[Page 7445]]



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 Sec. Sec.  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 Sec.  
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 Sec.  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 Sec. Sec.  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

[[Page 7446]]

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 Sec. Sec.  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

0
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).


Sec.  601.25  [Removed]

0
2. Remove Sec.  601.25.


Sec.  601.26  [Removed]

0
3. Remove Sec.  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

7446 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations

regulations designed to help ensure the The Regulatory Flexibility Act Therefore, under the Federal Food,
safety, purity, and potency of the requires Agencies to analyze regulatory Drug, and Cosmetic Act, the Public
licensed product, and that the product options that would minimize any Health Service Act, and under authority
is not misbranded. significant impact of a rule on small delegated to the Commissioner of Food
In addition, FDA continues to help entities. Because this final rule removes and Drugs, 21 CFR part 601 is amended
ensure the safety and effectiveness of regulations that are obsolete and no as follows:
licensed biological products through the longer necessary in light of other current
development and application of statutory and regulatory authorities, PART 601—LICENSING
additional standards and mechanisms. FDA certifies that the final rule will not
have a significant economic impact on ■ 1. The authority citation for 21 CFR
These mechanisms assist FDA in
a substantial number of small entities. part 601 continues to read as follows:
evaluating and monitoring the safety
and effectiveness of biological products. The Unfunded Mandates Reform Act Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
of 1995 (section 202(a)) requires us to 321, 351, 352, 353, 355, 356b, 360, 360c–
C. Summary of Comments to the prepare a written statement, which 360f, 360h-360j, 371, 374, 379e, 381; 42
Proposed Rule includes an assessment of anticipated U.S.C. 216, 241, 262, 263, 264; sec 122,
Pub. L. 105–115, 111 Stat. 2322 (21 U.S.C.
FDA did not receive any comments on costs and benefits, before issuing ‘‘any
355 note).
the proposed rule. rule that includes any Federal mandate
that may result in the expenditure by § 601.25 [Removed]
D. General Overview of the Final Rule State, local, and tribal governments, in ■ 2. Remove § 601.25.
The final rule removes §§ 601.25 and the aggregate, or by the private sector, of
601.26 of the regulations, which $100,000,000 or more (adjusted § 601.26 [Removed]
prescribe procedures for FDA’s review annually for inflation) in any one year.’’ ■ 3. Remove § 601.26.
and classification of biological products The current threshold after adjustment
Dated: February 5, 2016.
licensed before July 1, 1972. FDA is for inflation is $144 million, using the
most current (2014) Implicit Price Leslie Kux,
taking this action because these
Deflator for the Gross Domestic Product. Associate Commissioner for Policy.
regulations are obsolete and no longer
This final rule would not result in any [FR Doc. 2016–02884 Filed 2–11–16; 8:45 am]
necessary in light of other statutory and
regulatory authorities established since 1-year expenditure that would meet or BILLING CODE 4164–01–P

1972, which allow FDA to evaluate and exceed this amount.
monitor the safety and effectiveness of V. Analysis of Environmental Impact DEPARTMENT OF HEALTH AND
all biological products.
We have determined under 21 CFR HUMAN SERVICES
III. Legal Authority 25.30(h) that this action is of a type that
does not individually or cumulatively Food and Drug Administration
FDA is issuing this regulation under
the biological products provisions of the have a significant adverse effect on the
human environment. Therefore, neither 21 CFR Parts 868 and 870
PHS Act (42 U.S.C. 262 and 264) and
the drugs and general administrative an environmental assessment nor an [Docket No. FDA–2012–N–1174]
provisions of the FD&C Act (sections environmental impact statement is
201, 301, 501, 502, 503, 505, 510, 701, required. Anesthesiology Devices;
Reclassification of Membrane Lung for
and 704 (21 U.S.C. 321, 331, 351, 352, VI. Paperwork Reduction Act of 1995
Long-Term Pulmonary Support;
353, 355, 360, 371, and 374)). Under This final rule contains no collection Redesignation as Extracorporeal
these provisions of the PHS Act and the of information. Therefore, clearance by Circuit and Accessories for Long-Term
FD&C Act, we have the authority to OMB under the Paperwork Reduction Respiratory/Cardiopulmonary Failure
issue and enforce regulations designed Act of 1995 is not required.
to ensure that biological products are AGENCY: Food and Drug Administration,
safe, pure, and potent; and to prevent VII. Federalism HHS.
the introduction, transmission, and We have analyzed this final rule in ACTION: Final order.
spread of communicable disease. accordance with the principles set forth
in Executive Order 13132. FDA has SUMMARY: The Food and Drug
IV. Economic Analysis of Impacts
determined that the rule does not Administration (FDA) is issuing a final
We have examined the impacts of the contain policies that would have order to redesignate membrane lung
final rule under Executive Order 12866, substantial direct effects on the States, devices for long-term pulmonary
Executive Order 13563, the Regulatory on the relationship between the support, a preamendments class III
Flexibility Act (5 U.S.C. 601–612), and National Government and the States, or device, as extracorporeal circuit and
the Unfunded Mandates Reform Act of on the distribution of power and accessories for long-term respiratory/
1995 (Pub. L. 104–4). Executive Orders responsibilities among the various cardiopulmonary failure, and to
12866 and 13563 direct Agencies to levels of government. Accordingly, the reclassify the device to class II (special
assess all costs and benefits of available Agency has concluded that the rule does controls) in patients with acute
regulatory alternatives and, when not contain policies that have respiratory failure or acute
regulation is necessary, to select federalism implications as defined in cardiopulmonary failure where other
regulatory approaches that maximize the Executive order and, consequently, available treatment options have failed,
srobinson on DSK5SPTVN1PROD with RULES

net benefits (including potential a federalism summary impact statement and continued clinical deterioration is
economic, environmental, public health is not required. expected or the risk of death is
and safety, and other advantages; imminent. A membrane lung device for
distributive impacts; and equity). We List of Subjects in 21 CFR Part 601 long-term pulmonary support (>6 hours)
believe that this final rule is not a Administrative practice and refers to the oxygenator in an
significant regulatory action as defined procedure, Biologics, Confidential extracorporeal circuit used during long-
by Executive Order 12866. business information. term procedures, commonly referred to

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Document Created: 2016-02-12 01:24:02
Document Modified: 2016-02-12 01:24:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective March 14, 2016.
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.
FR Citation		81 FR 7445
CFR Associated		Administrative Practice and Procedure; Biologics and Confidential Business Information

81 FR 7445 - Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration