80 FR 37971 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 127 (July 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 127 (July 2, 2015)
| Page Range | 37971-37974 | |
| FR Document | 2015-16366 |
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)] [Rules and Regulations] [Pages 37971-37974] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16366] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 601, 610, and 680 [Docket No. FDA-2014-N-1110] Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics license applications (BLAs), or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to the Executive order. DATES: This rule is effective August 3, 2015. FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, 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: Executive Summary Purpose and Coverage of the Final Rule The final rule removes the codified GST \1\ regulations for biological products which will update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is finalizing [[Page 37972]] this action because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to Executive Order (E.O.) 13563 of January 18, 2011. --------------------------------------------------------------------------- \1\ For purposes of this final rule, the terms ``general safety test'' or ``GST'' refer to the requirements found under Title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 (21 CFR parts 600 through 680), specifically 21 CFR 610.11, 610.11a, and 680.3(b). --------------------------------------------------------------------------- Summary of the Major Provisions of the Final Rule The final rule removes the requirements contained in Sec. Sec. 610.11, 610.11a, and 680.3(b) (21 CFR 610.11, 610.11a, and 680.3(b)) from the regulations. Section 610.11 requires a GST for the detection of extraneous toxic contaminants in certain biological products intended for administration to humans. Section 610.11a concerns the GST requirements for inactivated influenza vaccine. Section 680.3(b) concerns GST requirements for allergenic products. Removal of these regulations, however, would not remove GST requirements specified in individual BLAs. A biological product manufacturer would continue to be required to follow the GST requirements specified in its BLA unless the manufacturer advised FDA of its elimination or modification of the test by a submission filed in accordance with Sec. 601.12 (21 CFR 601.12). FDA would review proposed changes to a manufacturer's approved biologics license on a case-by-case basis so that FDA can ensure that any such action is appropriate. Costs and Benefits FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. Because this final rule would impose no additional regulatory burdens, this rule is not anticipated to result in any compliance costs and the economic impact is expected to be minimal. I. Background As part of FDA's retrospective review of its regulations to promote improvement and innovation under Executive Order 13563, FDA is removing the codified GST requirements as specified in this rule. We believe this action is appropriate because in many instances, the GST regulations duplicate requirements that are also specified in the BLA requirements for biological products intended for human use under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), or they are outmoded or otherwise unnecessary to help ensure the continued safety, purity, and potency of biological products. FDA published the proposed rule ``Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications'' in the Federal Register of August 22, 2014 (79 FR 49727). FDA corrected the title of that proposed rule to ``Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications'' in the Federal Register of September 10, 2014 (79 FR 53670). For a number of years, FDA has not codified specific test methods as standards for licensed biological products, in part because codifying specific test methods as standards can diminish the ability of the Agency and industry to respond to technological developments. Instead the Agency has required manufacturers to provide a full description of manufacturing methods, including test methods, in manufacturers' BLAs (Sec. 601.2(a) (21 CFR 601.2(a))). Since FDA issued the March 2003 final rule ``Revision to the General Safety Requirements for Biological Products'' in the Federal Register of March 4, 2003 (68 FR 10157), it has become increasingly clear that the codified GST regulations are too restrictive for certain biological products because alternatives may be available which provide the same or greater level of assurance of safety as the GST. Thus, the Agency believes that the GST regulations may not always reflect the scientific community's assessment of the best current testing procedures, although in certain circumstances the GST may still be appropriate. The Agency believes that a more efficient way of prescribing testing requirements for particular products would be to allow such requirements to be specified in the BLA, which will enhance flexibility to make appropriate changes to testing methods. II. Summary of the Final Rule FDA is adopting as final, without material change, the proposed revocation of general safety test requirements that are duplicative of requirements in BLAs.The final rule is removing Sec. Sec. 610.11, 610.11a, and 680.3(b), the regulations that require that manufacturers of biological products perform a specified test for general safety of biological products. FDA is taking this action because the existing codified GST regulations are duplicative, outmoded, or are otherwise unnecessary to help ensure the continued safety, purity, and potency of licensed biological products. As set forth in an approved BLA or BLA supplement, for products that present specific safety concerns, manufacturers will be required to perform appropriate safety test(s) to address those concerns. For example, the BLA may require testing for a specific toxicity. The appropriate tests will be specified in the manufacturer's BLA or BLA supplement rather than codified as regulations. Elimination of the codified GST regulations would encourage the implementation of the principles of the ``3Rs,'' to reduce, refine, and replace animal use in testing. This addresses the need to minimize the use of animals in such testing and promotes more humane, appropriate and specific test methods for assuring the safety of biological products.\2\ --------------------------------------------------------------------------- \2\ Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 (42 U.S.C. 285l-3). Additional information on the Federal Government's implementation of the principles of the 3Rs may be found at the ICCVAM Web site at http://ntp.niehs.nih.gov/go/iccvam. --------------------------------------------------------------------------- The finalization of this rule does not automatically revise a manufacturer's BLA or BLA supplement. Manufacturers would continue to be required to perform the GST unless the manufacturer's BLA were revised through a supplement to eliminate or modify the test in accordance with Sec. 601.12. The requirements for a licensed biological product manufacturer to report changes in its product, product labeling, production process, quality controls, equipment, facilities or responsible personnel, as established in its approved BLA, are detailed in Sec. 601.12. Under Sec. 601.12, manufacturers must report each change to the Agency in one of several different types of submissions. The applicable submission category depends on the potential for the change(s) at issue to have an adverse effect on the identity, strength, quality, purity, or potency of the particular biological product as it may relate to the safety or effectiveness of the product. FDA anticipates that changes involving the discontinuance of the GST or the reliance on a test other than the GST would have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as it may relate to the safety [[Page 37973]] or effectiveness of the product. Such changes must be identified in a supplement submitted under Sec. 601.12(c) (changes requiring supplement submission at least 30 days prior to distribution of the product made using the change). III. Legal Authority FDA is issuing this regulation under the biological products and communicable disease provisions of the PHS Act (42 U.S.C. 262 and 264), and the provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321 et seq.) applicable to drugs. Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure, among other things, that biological products are safe, pure, and potent and manufactured in accordance with current Good Manufacturing Practice, and to prevent the introduction, transmission, or spread of communicable disease. IV. Comments on the Proposed Rule and FDA Response The Agency received two letters of comments on the proposed rule. Comments were received from a trade association, and an animal welfare organization. To make it easier to identify the comments and our responses, the word ``Comment'' and a comment number appear in parentheses before each comment's description, and the word ``Response'' in parentheses precedes each response. We have also numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received. Certain comments were grouped together because the subject matter of the comments was similar. A. General Comments (Comment 1) Both letters of comments support the proposed rule. (Response) FDA acknowledges and appreciates that the comments we received agree with the need for this rulemaking. As stated previously, the rule removes the requirements contained in Sec. Sec. 610.11, 610.11a, and 680.3(b) from the regulations because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. Removal of these regulations provides a more efficient way of prescribing testing requirements and enhances flexibility to make appropriate changes to testing methods. B. Comments on Specific Topics (Comment 2) One comment requests that FDA encourage manufacturers who have a GST described in their BLAs for their licensed products to submit supplements to their BLAs to eliminate or modify the test and that FDA take additional steps to ensure that the final rule will have the intended effect of eliminating the use of animals in safety testing. (Response) As stated in the preamble of the proposed rule (79 FR 49727 at 49729), we anticipate that the elimination of the codified GST regulations will encourage the implementation of the principles of the ``3Rs,'' to reduce, refine, and replace animal use in testing. Moreover, on our own initiative, as discussed elsewhere in this document, we have determined that the effective date of the final rule will be 30 days after the date of its publication in the Federal Register to give manufacturers the flexibility to submit supplements to their BLAs for their licensed products as soon as possible. (Comment 3) One comment requests that we add language to Sec. 601.2 or other relevant biologics regulation to clarify our intent to encourage the implementation of the principles of the 3Rs. (Response) FDA declines to adopt this recommended change because the request to add language to Sec. 601.2 or other relevant biologics regulations is outside the scope of this rulemaking. (Comment 4) One comment requests that FDA establish user fees with respect to the continued use of the GST after the effective date of this final rule, or that FDA establish other clear policies that will provide economic incentives to discontinue the use of the GST. Further, the comment refers to Executive Order 13563, which encourages Federal Agencies to ``. . . assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees . . . .'' (Response) We decline to adopt these suggested changes because they are beyond the scope of this rule. The proposed rule did not address user fees or economic incentives. This rule allows, but does not require, current BLA holders to submit to FDA supplements to their BLAs to eliminate or modify the GST. (Comment 5) One comment states that a manufacturer who submits a supplement to eliminate or modify a GST in its BLA will not be able to stop conducting the GST until FDA determines that the manufacturer has appropriately reported this change. (Response) We disagree in part. As stated in the preamble to the proposed rule (79 FR 49727 at 49730), a manufacturer who desires to discontinue the GST in its approved BLA or utilize an alternative method other than the GST approved in its BLA must submit a BLA supplement reporting the change in accordance with Sec. 601.12. Should a manufacturer wish to discontinue the GST described in the approved BLA, or to utilize an alternative method other than the GST approved in its BLA, FDA anticipates that the change would have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as it may relate to the safety or effectiveness of the product. Accordingly, a manufacturer who desires to make such a change must submit a BLA supplement reporting the change in accordance with Sec. 601.12(c). Within 30 days of the date FDA receives the submission, FDA will determine if the change has been reported in the proper category and if any of the required information is missing, and will inform the applicant accordingly. If FDA does not so notify the applicant, distribution of the product made using the change may begin not less than 30 days after receipt of the supplement by FDA. V. Conforming Amendments As part of this final rule, we need to make conforming changes when the removed provisions are referenced elsewhere in the CFR. The final rule removes ``Sec. 610.11'' from Sec. 601.2(c)(1) and 21 CFR 601.22. VI. Effective Date We are making this rule effective 30 days after the date of publication in the Federal Register. We are making this change in the interest of reducing unnecessary regulatory burden to give manufacturers the flexibility to submit supplements right away, should they wish to do so. VII. Economic Analysis of Impacts FDA has 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 [[Page 37974]] regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action as defined under 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 generally increases flexibility for safety testing and would result in the reduction of certain regulatory burdens and does not add any new regulatory responsibilities, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies 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 $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. This final rule amends the biologics regulations by removing the GST requirements for biological products found in Sec. Sec. 610.11, 610.11a and 680.3(b). FDA is finalizing this action because the current codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. The removal of the GST regulations for biological products, however, would not remove GST requirements specified in individual BLAs. All manufacturers that currently conduct a GST are already required, as part of the standards specified in their BLAs, to perform the GST and would thus continue to be required to perform the GST unless the BLA were revised to eliminate or modify the test through a supplement in accordance with Sec. 601.12. Because this rule would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal. VIII. The Paperwork Reduction Act of 1995 This final rule refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in Sec. 601.12 have been approved under OMB control number 0910-0338. Therefore, FDA tentatively concludes that the requirements in this document are not subject to review by OMB because they do not constitute a ``new collection of information'' under the PRA. IX. Environmental Impact The Agency has determined under 21 CFR 25.30(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. X. Federalism FDA has 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 21 CFR Part 601 Administrative practice and procedure, Biologics, Confidential business information. 21 CFR Part 610 Biologics, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 680 Biologics, Blood, Reporting and recordkeeping requirements. 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 parts 601, 610, and 680 are 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. 601.2 [Amended] 0 2. Section 601.2 is amended in paragraph (c)(1) by removing ``610.11,''. Sec. 601.22 [Amended] 0 3. Section 601.22 is amended in the third sentence by removing ``610.11,''. PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS 0 4. The authority citation for 21 CFR part 610 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264. Sec. 610.11 [Removed and Reserved] 0 5. Remove and reserve Sec. 610.11. Sec. 610.11a [Removed and Reserved] 0 6. Remove and reserve Sec. 610.11a. PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS 0 7. The authority citation for 21 CFR part 680 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264. Sec. 680.3 [Amended] 0 8. In Sec. 680.3, remove and reserve paragraph (b). Dated: June 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16366 Filed 7-1-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Rules and Regulations 37971
cause exists for dispensing with the 20 CFR Part 416 them earlier or extend them beyond that
notice and public comment procedures Administrative practice and date by notice of a final rule in the
for this rule. 5 U.S.C. 553(b)(B). This procedure, Aged, Blind, Disability Federal Register.
final rule only extends the date on benefits, Public assistance programs, [FR Doc. 2015–16397 Filed 7–1–15; 8:45 am]
which the pilot program will no longer Reporting and recordkeeping BILLING CODE 4191–02–P
be effective. It makes no substantive requirements, Supplemental Security
changes to our rules. Our current Income (SSI).
regulations expressly provide that we
Carolyn W. Colvin, DEPARTMENT OF HEALTH AND
may extend the expiration date of the
HUMAN SERVICES
pilot program by notice of a final rule Acting Commissioner of Social Security.
in the Federal Register. Therefore, we For the reasons stated in the Food and Drug Administration
have determined that opportunity for preamble, we are amending subpart J of
prior comment is unnecessary, and we part 404 and subpart N of part 416 of 21 CFR Parts 601, 610, and 680
are issuing this rule as a final rule. title 20 of the Code of Federal
In addition, for the reasons cited Regulations as set forth below: [Docket No. FDA–2014–N–1110]
above, we find good cause for
dispensing with the 30-day delay in the PART 404—FEDERAL OLD-AGE, Revocation of General Safety Test
effective date of this final rule. 5 U.S.C. SURVIVORS AND DISABILITY Regulations That Are Duplicative of
553(d)(3). We are not making any INSURANCE Requirements in Biologics License
substantive changes in our rules. Applications
(1950– )
Without an extension of the expiration AGENCY: Food and Drug Administration,
date for the pilot program, we will not Subpart J—[Amended] HHS.
have the flexibility we need to ensure
■ 1. The authority citation for subpart J ACTION: Final rule.
the efficiency of our hearing process.
Therefore, we find it is in the public of part 404 continues to read as follows: SUMMARY: The Food and Drug
interest to make this final rule effective Authority: Secs. 201(j), 204(f), 205(a)–(b), Administration (FDA) is amending the
on the publication date. (d)–(h), and (j), 221, 223(i), 225, and 702(a)(5) biologics regulations by removing the
of the Social Security Act (42 U.S.C. 401(j), general safety test (GST) requirements
Executive Order 12866 as 404(f), 405(a)–(b), (d)–(h), and (j), 421, 423(i),
Supplemented by Executive Order for biological products. FDA is
425, and 902(a)(5)); sec. 5, Pub. L. 97–455, 96
13563 Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)–
finalizing this action because the
(e), and 15, Pub. L. 98–460, 98 Stat. 1802 (42 existing codified GST regulations are
We consulted with the Office of duplicative of requirements that are also
Management and Budget (OMB) and U.S.C. 421 note); sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note). specified in biologics license
determined that this final rule does not applications (BLAs), or are no longer
meet the criteria for a significant ■ 2. In § 404.936, revise the second
necessary or appropriate to help ensure
regulatory action under Executive Order sentence in paragraph (i) to read as
the safety, purity, and potency of
12866, as supplemented by Executive follows:
licensed biological products. FDA is
Order 13563. Therefore, OMB did not taking this action as part of its
§ 404.936 Time and place for a hearing
review the final rule. before an administrative law judge. retrospective review of its regulations to
Regulatory Flexibility Act * * * * * promote improvement and innovation,
We certify that this final rule will not (i) Pilot program. * * * These in response to the Executive order.
have a significant economic impact on provisions will no longer be effective on DATES: This rule is effective August 3,
a substantial number of small entities August 12, 2016, unless we terminate 2015.
because it affects individuals only. them earlier or extend them beyond that
FOR FURTHER INFORMATION CONTACT: Lori
Therefore, the Regulatory Flexibility date by notice of a final rule in the
J. Churchyard, Center for Biologics
Act, as amended, does not require us to Federal Register.
Evaluation and Research, Food and
prepare a regulatory flexibility analysis. Drug Administration, 10903 New
PART 416—SUPPLEMENTAL
Paperwork Reduction Act SECURITY INCOME FOR THE AGED, Hampshire Ave., Bldg. 71, Rm. 7301,
BLIND, AND DISABLED Silver Spring, MD 20993–0002, 240–
This final rule does not create any 402–7911.
new or affect any existing collections
Subpart N—[Amended] SUPPLEMENTARY INFORMATION:
and, therefore, does not require OMB
approval under the Paperwork ■ 3. The authority citation for subpart N Executive Summary
Reduction Act. of part 416 continues to read as follows: Purpose and Coverage of the Final Rule
(Catalog of Federal Domestic Assistance Authority: Secs. 702(a)(5), 1631, and 1633
Program Nos. 96.001, Social Security— of the Social Security Act (42 U.S.C.
The final rule removes the codified
Disability Insurance; 96.002, Social 902(a)(5), 1383, and 1383b); sec. 202, Pub. L. GST 1 regulations for biological products
Security—Retirement Insurance; 96.004, 108–203, 118 Stat. 509 (42 U.S.C. 902 note). which will update outdated
asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
Social Security—Survivors Insurance; requirements and accommodate new
96.006, Supplemental Security Income.) ■ 4. In § 416.1436, revise the second
sentence in paragraph (i) to read as and evolving technology and testing
List of Subjects follows: capabilities without diminishing public
health protections. FDA is finalizing
20 CFR Part 404 § 416.1436 Time and place for a hearing
Administrative practice and before an administrative law judge. 1 For purposes of this final rule, the terms
procedure, Blind, Disability benefits, * * * * * ‘‘general safety test’’ or ‘‘GST’’ refer to the
requirements found under Title 21 of the Code of
Old-age, Survivors, and Disability (i) Pilot program. * * * These Federal Regulations (CFR), subchapter F, parts 600
Insurance, Reporting and recordkeeping provisions will no longer be effective on through 680 (21 CFR parts 600 through 680),
requirements, Social Security. August 12, 2016, unless we terminate specifically 21 CFR 610.11, 610.11a, and 680.3(b).
VerDate Sep<11>2014 23:22 Jul 01, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\02JYR1.SGM 02JYR1](https://thefederalregister.org/doc/80_FR_38098/page/1.svg)
![37974 Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Rules and Regulations
regulatory approaches that maximize VIII. The Paperwork Reduction Act of PART 601—LICENSING
net benefits (including potential 1995
economic, environmental, public health ■ 1. The authority citation for 21 CFR
and safety, and other advantages; This final rule refers to previously part 601 continues to read as follows:
distributive impacts; and equity). The approved collections of information that Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
Agency believes that this final rule is are subject to review by the Office of 321, 351, 352, 353, 355, 356b, 360, 360c–
not a significant regulatory action as Management and Budget (OMB) under 360f, 360h–360j, 371, 374, 379e, 381; 42
defined under Executive Order 12866. the Paperwork Reduction Act of 1995 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub.
The Regulatory Flexibility Act (PRA) (44 U.S.C. 3501–3520). The L. 105–115, 111 Stat. 2322 (21 U.S.C. 355
requires Agencies to analyze regulatory collections of information in § 601.12 note).
options that would minimize any have been approved under OMB control
§ 601.2 [Amended]
significant impact of a rule on small number 0910–0338. Therefore, FDA
entities. Because this final rule generally tentatively concludes that the ■ 2. Section 601.2 is amended in
increases flexibility for safety testing requirements in this document are not paragraph (c)(1) by removing ‘‘610.11,’’.
and would result in the reduction of subject to review by OMB because they
§ 601.22 [Amended]
certain regulatory burdens and does not do not constitute a ‘‘new collection of
add any new regulatory responsibilities, information’’ under the PRA. ■ 3. Section 601.22 is amended in the
the Agency certifies that the final rule third sentence by removing ‘‘610.11,’’.
IX. Environmental Impact
will not have a significant economic
impact on a substantial number of small PART 610—GENERAL BIOLOGICAL
The Agency has determined under 21 PRODUCTS STANDARDS
entities. CFR 25.30(h) that this action is of a type
Section 202(a) of the Unfunded that does not individually or ■ 4. The authority citation for 21 CFR
Mandates Reform Act of 1995 requires cumulatively have a significant effect on part 610 continues to read as follows:
that Agencies prepare a written the human environment. Therefore,
statement, which includes an Authority: 21 U.S.C. 321, 331, 351, 352,
neither an environmental assessment 353, 355, 360, 360c, 360d, 360h, 360i, 371,
assessment of anticipated costs and nor an environmental impact statement 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
benefits, before proposing ‘‘any rule that is required. 264.
includes any Federal mandate that may
result in the expenditure by State, local, X. Federalism § 610.11 [Removed and Reserved]
and tribal governments, in the aggregate, ■ 5. Remove and reserve § 610.11.
or by the private sector, of $100,000,000 FDA has analyzed this final rule in
or more (adjusted annually for inflation) accordance with the principles set forth § 610.11a [Removed and Reserved]
in any one year.’’ The current threshold in Executive Order 13132. FDA has
determined that the rule does not ■ 6. Remove and reserve § 610.11a.
after adjustment for inflation is $144
million, using the most current (2014) contain policies that would have
PART 680—ADDITIONAL STANDARDS
Implicit Price Deflator for the Gross substantial direct effects on the States,
FOR MISCELLANEOUS PRODUCTS
Domestic Product. FDA does not expect on the relationship between the
this final rule to result in any 1-year National Government and the States, or ■ 7. The authority citation for 21 CFR
expenditure that would meet or exceed on the distribution of power and part 680 continues to read as follows:
this amount. responsibilities among the various
Authority: 21 U.S.C. 321, 351, 352, 353,
This final rule amends the biologics levels of government. Accordingly, the 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,
regulations by removing the GST Agency has concluded that the rule does 264.
requirements for biological products not contain policies that have
found in §§ 610.11, 610.11a and federalism implications as defined in § 680.3 [Amended]
680.3(b). FDA is finalizing this action the Executive order and, consequently, ■ 8. In § 680.3, remove and reserve
because the current codified GST a federalism summary impact statement paragraph (b).
regulations are duplicative of is not required.
Dated: June 26, 2015.
requirements that are also specified in
List of Subjects Leslie Kux,
biologics licenses, or are no longer
necessary or appropriate to help ensure 21 CFR Part 601 Associate Commissioner for Policy.
the safety, purity, and potency of [FR Doc. 2015–16366 Filed 7–1–15; 8:45 am]
licensed biological products. The Administrative practice and BILLING CODE 4164–01–P
removal of the GST regulations for procedure, Biologics, Confidential
biological products, however, would not business information.
remove GST requirements specified in 21 CFR Part 610 DEPARTMENT OF STATE
individual BLAs. All manufacturers that
currently conduct a GST are already Biologics, Labeling, Reporting and 22 CFR Part 121
required, as part of the standards recordkeeping requirements. [Public Notice: 8996]
specified in their BLAs, to perform the
asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
GST and would thus continue to be 21 CFR Part 680 RIN 1400–AD74
required to perform the GST unless the
Biologics, Blood, Reporting and Temporary Modification of Category XI
BLA were revised to eliminate or
recordkeeping requirements. of the United States Munitions List
modify the test through a supplement in
accordance with § 601.12. Because this Therefore under the Federal Food, AGENCY: Department of State.
rule would impose no additional Drug, and Cosmetic Act, the Public ACTION:Final rule; notice of temporary
regulatory burdens, this regulation is Health Service Act, and under authority modification.
not anticipated to result in any delegated to the Commissioner of Food
compliance costs and the economic and Drugs, 21 CFR parts 601, 610, and SUMMARY: The Department of State,
impact is expected to be minimal. 680 are amended as follows: pursuant to its regulations and in the
VerDate Sep<11>2014 23:22 Jul 01, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\02JYR1.SGM 02JYR1](https://thefederalregister.org/doc/80_FR_38098/page/4.svg)
Document Created: 2015-12-15 13:15:40
Document Modified: 2015-12-15 13:15:40
| 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 August 3, 2015. | |
| Contact | Lori J. Churchyard, 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 | 80 FR 37971 | |
| CFR Citation | 21
CFR
601 21 CFR 610 21 CFR 680 | |
| CFR Associated | Administrative Practice and Procedure; Biologics; Confidential Business Information; Labeling; Reporting and Recordkeeping Requirements and Blood |
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