Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Availability, 16344-16345 [2014-06471]

Download as PDF 16344 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices that are performing waived testing in addition to moderate or high complexity testing will need to meet all requirements in subpart K, Quality System for Nonwaived Testing. The A2LA has more specific requirements for laboratory information systems than CLIA. In addition, prior to adding a new test to the laboratory’s accreditation, the A2LA requires the laboratory to submit performance specifications for review and approval. E. Subpart M—Personnel for Nonwaived Testing We have determined that the A2LA’s requirements are equal to or more stringent than the CLIA requirements at § 493.1403 through § 493.1495 for laboratories that perform moderate and high complexity testing. Under the A2LA’s requirements, laboratories that perform moderate complexity testing must meet the personnel requirements for high complexity testing located at § 493.1441 through § 493.1495. emcdonald on DSK67QTVN1PROD with NOTICES F. Subpart Q—Inspections We have determined that the A2LA requirements for the submitted subspecialties and specialties are equal to or more stringent than the CLIA requirements at § 493.1771 through § 493.1780. The A2LA requires a two day onsite surveillance visit one year after the initial accreditation is granted. The A2LA requires annual review of all accredited laboratories. The laboratory is required to submit any updates on information about its organization, facilities, key personnel and results of any proficiency testing. Laboratories may be required to undergo an onsite surveillance visit if they do not submit their annual review documentation to the A2LA by the established 30 day deadline, if significant changes to the facility or organization have occurred, or if proficiency testing results have been consistently poor. The CLIA regulations do not have this requirement. G. Subpart R—Enforcement Procedures The A2LA meets the requirements of subpart R to the extent that it applies to accreditation organizations. The A2LA policy sets forth the actions the organization takes when laboratories it accredits do not comply with its requirements and standards for accreditation. When appropriate, the A2LA will deny, suspend, or revoke accreditation in a laboratory accredited by the A2LA and report that action to us within 30 days. The A2LA also provides an appeals process for laboratories that have had accreditation denied, suspended, or revoked. VerDate Mar<15>2010 18:16 Mar 24, 2014 Jkt 232001 We have determined that the A2LA’s laboratory enforcement and appeal policies are equal to the requirements of part 493, subpart R as they apply to accreditation organizations. VII. Executive Order 12866 Statement In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget. IV. Federal Validation Inspections and Continuing Oversight Authority: Section 353 of the Public Health Service Act (42 U.S.C. 263a). The Federal validation inspections of laboratories accredited by the A2LA may be conducted on a representative sample basis or in response to substantial allegations of noncompliance (that is, complaint inspections). The outcome of those validation inspections, performed by CMS or our agents, or the State survey agencies, will be our principal means for verifying that the laboratories accredited by the A2LA remain in compliance with CLIA requirements. This Federal monitoring is an ongoing process. Dated: March 14, 2014. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. V. Removal of Approval as an Accrediting Organization Our regulations provide that we may rescind the approval of an accreditation organization, such as that of the A2LA, for cause, before the end of the effective date of approval. If we determine that the A2LA has failed to adopt, maintain and enforce requirements that are equal to, or more stringent than, the CLIA requirements, or that systemic problems exist in its monitoring, inspection or enforcement processes, we may impose a probationary period, not to exceed 1 year, in which the A2LA would be allowed to address any identified issues. Should the A2LA be unable to address the identified issues within that timeframe, we may, in accordance with the applicable regulations, revoke A2LA’s deeming authority under CLIA. Should circumstances result in our withdrawal of the A2LA’s approval, we will publish a notice in the Federal Register explaining the basis for removing its approval. VI. Collection of Information Requirements This notice does not impose any information collection and record keeping requirements subject to the Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget (OMB) under the authority of the PRA. The requirements associated with the accreditation process for clinical laboratories under the CLIA program, codified in 42 CFR part 493 subpart E, are currently approved by OMB under OMB approval number 0938–0686. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 [FR Doc. 2014–06512 Filed 3–24–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0250] Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.’’ This draft guidance discusses FDA’s recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter ‘‘accelerated approval’’). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 27, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, SUMMARY: E:\FR\FM\25MRN1.SGM 25MRN1 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices Silver Spring, MD 20993–0002, or Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ann Marie Trentacosti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993–0002, 301– 796–2901; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301– 827–6210. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.’’ Labeling must conform to the content and format requirements delineated in §§ 201.56(d) and 201.57 (21 CFR 201.56(d) and 201.57). Special provisions exist for older drug labeling under §§ 201.56(e) and 201.80. Labeling for drugs approved under the accelerated approval process is fundamentally the same as for drugs approved under the traditional pathway; however, for drugs approved under accelerated approval there are additional labeling requirements as described in § 201.57(c)(2)(i)(B) and recommended elements for consideration. This draft guidance discusses FDA’s recommendations for developing the indication and usage statements in the prescribing information for drugs approved under accelerated approval as defined in 21 CFR part 314, subpart H (for new drug applications) and 21 CFR part 601, subpart E (for biologics license applications) when the approval is based on an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured VerDate Mar<15>2010 18:16 Mar 24, 2014 Jkt 232001 earlier than an effect on irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval under 21 CFR 314.560 or 21 CFR 601.46, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on labeling for human prescription drug and biologic products approved under accelerated approval. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance 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 (44 U.S.C. 3501–3520). The collections of information in §§ 201.56 and 201.57 have been approved under OMB control number 0910–0572. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/biologicsbloodVaccines/ GuidanceComplianceRegulatory Information/guidances/default.htm, or https://www.regulations.gov. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 16345 Dated: March 19, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–06471 Filed 3–24–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Hispanic Community Health Study/Study of Latinos (HCHS/ SOL) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Larissa AvilesSanta, 6701 Rockledge, Epidemiology Branch, Program in Prevention and Population Sciences, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., MSC 7936, Bethesda, MD 20892–7936, or call non-toll-free number 301–435–0450, or Email your request, including your address to avilessantal@nhlbi.nih.gov. Formal requests for additional plans and SUMMARY: E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16344-16345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06471]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0250]


Draft Guidance for Industry on Labeling for Human Prescription 
Drug and Biological Products Approved Under the Accelerated Approval 
Regulatory Pathway; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Labeling for 
Human Prescription Drug and Biological Products Approved Under the 
Accelerated Approval Regulatory Pathway.'' This draft guidance 
discusses FDA's recommendations for developing the indication and usage 
statements in the prescribing information for drugs approved under the 
accelerated approval regulatory pathway (hereafter ``accelerated 
approval''). The guidance also discusses labeling considerations for 
indications approved under accelerated approval when clinical benefit 
has been verified and FDA terminates the conditions of accelerated 
approval, or when FDA withdraws accelerated approval of an indication 
while other indications for the drug remain approved.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 27, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201,

[[Page 16345]]

Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and 
Development (HFM-40), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ann Marie Trentacosti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-
796-2901; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Labeling for Human Prescription Drug and Biological Products 
Approved Under the Accelerated Approval Regulatory Pathway.'' Labeling 
must conform to the content and format requirements delineated in 
Sec. Sec.  201.56(d) and 201.57 (21 CFR 201.56(d) and 201.57). Special 
provisions exist for older drug labeling under Sec. Sec.  201.56(e) and 
201.80. Labeling for drugs approved under the accelerated approval 
process is fundamentally the same as for drugs approved under the 
traditional pathway; however, for drugs approved under accelerated 
approval there are additional labeling requirements as described in 
Sec.  201.57(c)(2)(i)(B) and recommended elements for consideration.
    This draft guidance discusses FDA's recommendations for developing 
the indication and usage statements in the prescribing information for 
drugs approved under accelerated approval as defined in 21 CFR part 
314, subpart H (for new drug applications) and 21 CFR part 601, subpart 
E (for biologics license applications) when the approval is based on an 
effect on a surrogate endpoint that is reasonably likely to predict 
clinical benefit, or an effect on a clinical endpoint that can be 
measured earlier than an effect on irreversible morbidity or mortality, 
that is reasonably likely to predict an effect on irreversible 
morbidity or mortality or other clinical benefit. The guidance also 
discusses labeling considerations for indications approved under 
accelerated approval when clinical benefit has been verified and FDA 
terminates the conditions of accelerated approval under 21 CFR 314.560 
or 21 CFR 601.46, or when FDA withdraws accelerated approval of an 
indication while other indications for the drug remain approved.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on labeling for 
human prescription drug and biologic products approved under 
accelerated approval. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance 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 (44 U.S.C. 3501-
3520). The collections of information in Sec. Sec.  201.56 and 201.57 
have been approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/biologicsbloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm, or 
https://www.regulations.gov.

    Dated: March 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06471 Filed 3-24-14; 8:45 am]
BILLING CODE 4160-01-P
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