81 FR 44883 - Updating Abbreviated New Drug Application Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 132 (July 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44883-44885 | |
| FR Document | 2016-16157 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Notices] [Pages 44883-44885] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16157] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1673] Updating Abbreviated New Drug Application Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn.'' This draft guidance describes a process for updating labeling for abbreviated new drug applications (ANDAs) in cases where FDA has withdrawn approval of the new drug application (NDA) for the ANDA's reference listed drug (RLD) for reasons other than safety or effectiveness. The process described in this guidance is intended to complement existing Agency authorities and processes. DATES: Although you can comment on any guidance at any time (see 21 CFR [[Page 44884]] 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 9, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2016-D-1673 for ``Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 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 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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. FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 301-796-3381, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn.'' This draft guidance describes a process for updating labeling for ANDAs in cases where FDA has withdrawn approval of the NDA for the ANDA's RLD for reasons other than safety or effectiveness. A generic drug is required to have the same labeling as the RLD at the time of approval, except for changes required because of differences approved under a suitability petition (see section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and 21 CFR 314.93) or because the generic drug and the RLD are ``produced or distributed by different manufacturers'' (see section 505(j)(2)(A)(v) of the FD&C Act and Sec. 314.94(a)(8)(iv) (21 CFR 314.94(a)(8)(iv))). As a general matter, all holders of marketing applications for drug products have an ongoing obligation to ensure their product labeling is accurate, and not false or misleading. ANDA holders are expected to update their labeling after FDA has approved relevant changes to the labeling for the corresponding NDA RLD. Where approval of an NDA RLD has been withdrawn, the NDA holder can no longer update labeling for the withdrawn RLD. The labeling of ANDAs that rely on the withdrawn RLD might eventually become inaccurate and outdated, resulting in labeling that is false and/or misleading, for example. Likewise, new original ANDAs that rely on the withdrawn RLD might include proposed labeling based on the last approved RLD labeling that includes outdated information that is false and/or misleading. This draft guidance clarifies that consistent with the statute, where the RLD is withdrawn, certain labeling changes may continue to be made for pending ANDAs and marketed ANDAs. This draft guidance sets forth a process for making such changes. The process described in this guidance is intended to complement existing Agency authorities and processes. 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 current thinking of FDA [[Page 44885]] on the process for updating ANDA labeling after approval of the NDA for the RLD has been withdrawn. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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. 314.94(a)(8) and 21 CFR 314.97 have been approved under OMB Control No. 0910-0001. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16157 Filed 7-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44883
172,200 prescription orders for documenting this information will take under section 503A should also
compounded drugs (‘‘total annual approximately 2 minutes per maintain records of prescriptions for
disclosures’’ in table 1, line 1). We prescription order. identified individual patients including
estimate that the consultation between Compounders under section 503A notations that a prescriber has
the compounder and the prescriber and should maintain records of the determined that the compounded drug
adding a notation to each prescription frequency in which they have has a change that produces a significant
that does not already document this compounded drug products that are difference for the identified patient.
determination will take approximately 3 essentially copies of commercially Because the time, effort, and financial
minutes per prescription order. available drug products and the number resources necessary to comply with this
In addition, if the drug was of prescriptions that they have filled for collection of information would be
compounded because the approved compounded drug products that are incurred by licensed pharmacists and
product was not commercially available essentially copies of commercially licensed physicians in the normal
because it was on the FDA drug shortage available drug products to document course of their activities, it is excluded
list, the prescription or a notation on the that such compounding has not been from the definition of ‘‘burden’’ under 5
prescription should note that it was on done ‘‘regularly’’ or in ‘‘inordinate CFR 1320.3(b)(2). FDA understands that
the drug shortage list and the date the amounts.’’ We estimate that a total of maintaining records of prescriptions for
list was checked. We estimate that a approximately 3,444 compounders compounded drug products is part of
total of approximately 6,888 (‘‘number of recordkeepers’’ in table 1) the usual course of the practice of
compounders (‘‘number of respondents’’ will keep approximately 165,312 compounding and selling drugs and is
in table 1, line 2) will document this records (‘‘total annual records’’). We required by States’ pharmacy laws and
information on approximately 344,400 estimate that maintaining the records other state laws governing
prescription orders for compounded will take approximately 2 minutes per recordkeeping by health care
drugs (‘‘total annual disclosures’’ in record. professionals and health care facilities.
table 1, line 2). We estimate that A licensed pharmacist or physician FDA estimates the burden of this
checking FDA’s drug shortage list and seeking to compound a drug product collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of reporting burden per Total hours
respondents per disclosures disclosure
respondent
Consultation between the compounder and prescriber and 6,888 50 344,400 3 minutes ....... 17,220
the notation on the prescription documenting the pre-
scriber’s determination of significant difference.
Checking FDA’s drug shortage list and documenting on 6,888 50 344,400 2 minutes ....... 11,480
the prescription that the drug is in shortage.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Type of recordkeeping records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Records of frequency and number of prescriptions filled 3,444 48 165,312 2 minutes ....... 5,510
for compounded drugs that are essentially a copy.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND announcing the availability of a draft
HUMAN SERVICES guidance for industry entitled
Persons with access to the Internet ‘‘Updating ANDA Labeling After the
may obtain the draft guidance at either Food and Drug Administration Marketing Application for the Reference
http://www.fda.gov/Drugs/Guidance Listed Drug Has Been Withdrawn.’’ This
ComplianceRegulatoryInformation/ [Docket No. FDA–2016–D–1673]
draft guidance describes a process for
Guidances/default.htm or http:// updating labeling for abbreviated new
Updating Abbreviated New Drug
www.regulations.gov. drug applications (ANDAs) in cases
Application Labeling After the
Dated: July 6, 2016. Marketing Application for the where FDA has withdrawn approval of
Leslie Kux, Reference Listed Drug Has Been the new drug application (NDA) for the
Associate Commissioner for Policy. Withdrawn; Draft Guidance for ANDA’s reference listed drug (RLD) for
sradovich on DSK3GDR082PROD with NOTICES
Industry; Availability reasons other than safety or
[FR Doc. 2016–16361 Filed 7–8–16; 8:45 am]
effectiveness. The process described in
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, this guidance is intended to
HHS. complement existing Agency authorities
ACTION: Notice. and processes.
SUMMARY: The Food and Drug DATES: Although you can comment on
Administration (FDA or Agency) is any guidance at any time (see 21 CFR
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![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44885
on the process for updating ANDA DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: When
labeling after approval of the NDA for HUMAN SERVICES submitting comments or requesting
the RLD has been withdrawn. It does information, please include the OMB
not establish any rights for any person Office of the Secretary control number 0990–0221 and
and is not binding on FDA or the public. [Document Identifier: HHS–OS–0990–0221– document identifier HHS–OS–0990–
You can use an alternative approach if 30D] 0221–30D for reference.
it satisfies the requirements of the Information Collection Request Title:
applicable statutes and regulations. Agency Information Collection Family Planning Annual Report: Forms
Activities; Submission to OMB for and Instructions.
II. Paperwork Reduction Act of 1995 Review and Approval; Public Comment Abstract: The Office of Population
Request Affairs within the Office of the Assistant
This draft guidance refers to Secretary for Health seeks to renew the
previously approved collections of AGENCY: Office of the Secretary, HHS. currently approved Family Planning
information found in FDA regulations. ACTION: Notice. Annual Report (FPAR) data collection
These collections of information are and reporting tool (OMB No. 0990–
subject to review by the Office of SUMMARY: In compliance with section
0221). This annual reporting
Management and Budget (OMB) under 3507(a)(1)(D) of the Paperwork
requirement is for family planning
the Paperwork Reduction Act of 1995 Reduction Act of 1995, the Office of the
services delivery projects authorized
(44 U.S.C. 3501–3520). The collections Secretary (OS), Department of Health
and funded by the title X Family
of information in § 314.94(a)(8) and 21 and Human Services, has submitted an
Planning Program [‘‘Population
Information Collection Request (ICR),
CFR 314.97 have been approved under Research and Voluntary Family
described below, to the Office of
OMB Control No. 0910–0001. Planning Programs’’ (Pub. L. 91–572)],
Management and Budget (OMB) for
which was enacted in 1970 as title X of
III. Electronic Access review and approval. The ICR is for
the Public Health Service Act (section
renewal of the approved information
Persons with access to the Internet 1001; 42 U.S.C. 300). The FPAR data
collection assigned OMB control
may obtain the document at either collection and reporting tool remains
number 0990–0221, scheduled to expire
http://www.fda.gov/Drugs/Guidance unchanged in this request to renew
on September 30, 2016. Comments
ComplianceRegulatoryInformation/ OMB approval to collect essential,
submitted during the first public review
Guidances/default.htm or http:// annual data from title X grantees.
of this ICR will be provided to OMB.
Likely Respondents: Respondents for
www.regulations.gov. OMB will accept further comments from
this annual reporting requirement are
Dated: June 21, 2016. the public on this ICR during the review
centers that receive funding directly
and approval period.
Leslie Kux, from OPA for family planning services
DATES: Comments on the ICR must be authorized and funded under the title X
Associate Commissioner for Policy.
received on or before August 10, 2016. Family Planning Program [‘‘Population
[FR Doc. 2016–16157 Filed 7–8–16; 8:45 am]
ADDRESSES: Submit your comments to Research and Voluntary Family
BILLING CODE 4164–01–P
OIRA_submission@omb.eop.gov or via Planning Programs’’ (Pub. L. 91–572)],
facsimile to (202) 395–5806. which was enacted in 1970 as title X of
FOR FURTHER INFORMATION CONTACT: the Public Health Service Act (section
Information Collection Clearance staff, 1001 of title X of the Public Health
Information.CollectionClearance@ Service Act, 42 United States Code
hhs.gov or (202) 690–6162. [U.S.C.] 300).
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of annualized Annualized
Form Number of
Type of respondent responses per burden per total burden
name respondents respondent response (hours)
(hours)
Grantees .............................................. FPAR ....... 93 grantees ......................................... 1 36 3,348
Totals ............................................ .................. 93 ......................................................... ........................ ........................ 3,348
Terry S. Clark, DEPARTMENT OF HEALTH AND SUMMARY: In compliance with the
Asst. Information Collection Clearance HUMAN SERVICES Paperwork Reduction Act of 1995 which
Officer. requires 30 days for public comment on
[FR Doc. 2016–16300 Filed 7–8–16; 8:45 am] Indian Health Service proposed information collection
BILLING CODE 4150–34–P projects, the Indian Health Service (IHS)
Request for Public Comment: 30-Day is submitting to the Office of
sradovich on DSK3GDR082PROD with NOTICES
Proposed Information Collection: Management and Budget (OMB) a
Indian Health Service Medical Staff request for an extension of a previously
Credentials and Privileges Files approved collection of information
titled, ‘‘Indian Health Service Medical
AGENCY: Indian Health Service, HHS.
Staff Credentials and Privileges Files,’’
ACTION: Notice. OMB Control Number 0917–0009,
which expires August 31, 2016. This
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Document Created: 2016-07-09 00:21:44
Document Modified: 2016-07-09 00:21:44
| 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 | Notices | |
| Action | Notice. | |
| 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 September 9, 2016. | |
| Contact | Emily Helms Williams, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 301-796-3381, [email protected] | |
| FR Citation | 81 FR 44883 |
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