81 FR 58516 - Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 165 (August 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 165 (August 25, 2016)
| Page Range | 58516-58517 | |
| FR Document | 2016-20399 |
[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)] [Notices] [Pages 58516-58517] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20399] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1292] Abbreviated New Drug Application Submissions--Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Abbreviated New Drug Application Submissions--Refuse to Receive for Lack of Justification of Impurity Limits.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive (RTR) an ANDA. DATES: Submit either electronic or written comments on Agency guidances at any time. 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-2014-D-1292 for ``Abbreviated New Drug Application Submissions-- Refuse to Receive for Lack of Justification of Impurity Limits.'' 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 [[Page 58517]] 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 this 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 guidance document. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Abbreviated New Drug Application Submissions--Refuse to Receive for Lack of Justification of Impurity Limits.'' This guidance is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights serious deficiencies in impurity information that may cause FDA to RTR an ANDA. Specifically, these deficiencies include: (1) Failing to provide justification for proposed limits for specified identified impurities in drug substances and drug products that are above qualification thresholds; (2) failing to provide justification for specified unidentified impurities that are above identification thresholds; and (3) proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds. FDA evaluates each submitted ANDA individually to determine whether it is sufficiently complete to permit a substantive review and thus can be received by FDA. The Agency cannot receive an ANDA unless it contains the information required under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and related regulations (e.g., 21 CFR 314.101(b)(1)). FDA issued the guidance for industry ``Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards'' to explain in some detail the kind of omissions that can lead to a RTR determination. A draft of this guidance was published on September 17, 2014, with the title ``ANDA Submissions--Refuse to Receive for Lack of Proper Justification of Impurity Limits.'' Upon review of the comments submitted to the draft guidance, FDA removed the word ``proper'' from the title to emphasize that this guidance does not apply to the technical review of impurity limit justifications submitted in an ANDA. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Abbreviated New Drug Application Submissions--Refuse to Receive for Lack of Justification of Impurity Limits.'' 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. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: August 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20399 Filed 8-24-16; 8:45 am] BILLING CODE 4164-01-P
![58516 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent
Center recruitment call screener (to confirm selection criteria and gain par-
ticipation; assumes outreach to 5 centers for every 1 center needed) ....... 360 1 .33 119
Center engagement call script (to gather basic characteristics and plan
steps for participation) .................................................................................. 72 1 .75 54
Implementation interview protocol ................................................................... 72 1 8 576
Electronic cost workbook ................................................................................. 72 1 6 432
Cost interview protocol .................................................................................... 72 1 2 144
Web-based time-use survey ............................................................................ 579 1 .5 290
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND such as medical information, your or
Hours: 1,615 hours. HUMAN SERVICES anyone else’s Social Security number, or
confidential business information, such
ADDITIONAL INFORMATION: In compliance Food and Drug Administration as a manufacturing process. Please note
with the requirements of Section that if you include your name, contact
3506(c)(2)(A) of the Paperwork [Docket No. FDA–2014–D–1292]
information, or other information that
Reduction Act of 1995, the identifies you in the body of your
Abbreviated New Drug Application
Administration for Children and Submissions—Refuse To Receive for comments, that information will be
Families is soliciting public comment Lack of Justification of Impurity Limits; posted on http://www.regulations.gov.
on the specific aspects of the Guidance for Industry; Availability • If you want to submit a comment
information collection described above. with confidential information that you
Copies of the proposed collection of AGENCY: Food and Drug Administration, do not wish to be made available to the
information can be obtained and HHS. public, submit the comment as a
comments may be forwarded by writing ACTION: Notice of availability. written/paper submission and in the
to the Administration for Children and manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug
Families, Office of Planning, Research Submissions’’ and ‘‘Instructions’’).
Administration (FDA or Agency) is
and Evaluation, 330 C Street SW., 4th announcing the availability of a Written/Paper Submissions
Floor, Washington, DC 20201, Attn: guidance for industry entitled
OPRE Reports Clearance Officer. Email Submit written/paper submissions as
‘‘Abbreviated New Drug Application follows:
address: OPREinfocollection@ Submissions—Refuse to Receive for • Mail/Hand delivery/Courier (for
acf.hhs.gov. All requests should be Lack of Justification of Impurity written/paper submissions): Division of
identified by the title of the information Limits.’’ This guidance is intended to Dockets Management (HFA–305), Food
collection. assist applicants preparing to submit to and Drug Administration, 5630 Fishers
The Department specifically requests FDA abbreviated new drug applications Lane, Rm. 1061, Rockville, MD 20852.
comments on (a) whether the proposed (ANDAs) and prior approval • For written/paper comments
collection of information is necessary supplements for which the applicant is submitted to the Division of Dockets
for the proper performance of the seeking approval of a new strength of Management, FDA will post your
functions of the agency, including the drug product. The guidance comment, as well as any attachments,
whether the information shall have highlights deficiencies about impurity except for information submitted,
practical utility; (b) the accuracy of the information that may cause FDA to marked and identified, as confidential,
refuse to receive (RTR) an ANDA. if submitted as detailed in
agency’s estimate of the burden of the
DATES: Submit either electronic or ‘‘Instructions.’’
proposed collection of information; (c)
written comments on Agency guidances Instructions: All submissions received
the quality, utility, and clarity of the
at any time. must include the Docket No. FDA–
information to be collected; and (d)
ADDRESSES: You may submit comments 2014–D–1292 for ‘‘Abbreviated New
ways to minimize the burden of the
as follows: Drug Application Submissions—Refuse
collection of information on to Receive for Lack of Justification of
respondents, including through the use Electronic Submissions Impurity Limits.’’ Received comments
of automated collection techniques or Submit electronic comments in the will be placed in the docket and, except
other forms of information technology. following way: for those submitted as ‘‘Confidential
Consideration will be given to • Federal eRulemaking Portal: http:// Submissions,’’ publicly viewable at
comments and suggestions submitted www.regulations.gov. Follow the http://www.regulations.gov or at the
within 60 days of this publication. instructions for submitting comments. Division of Dockets Management
Comments submitted electronically, between 9 a.m. and 4 p.m., Monday
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Robert Sargis,
including attachments, to http:// through Friday.
ACF Reports Clearance Officer. www.regulations.gov will be posted to • Confidential Submissions—To
[FR Doc. 2016–20386 Filed 8–24–16; 8:45 am] the docket unchanged. Because your submit a comment with confidential
BILLING CODE 4184–23–P comment will be made public, you are information that you do not wish to be
solely responsible for ensuring that your made publicly available, submit your
comment does not include any comments only as a written/paper
confidential information that you or a submission. You should submit two
third party may not wish to be posted, copies total. One copy will include the
VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1](https://thefederalregister.org/doc/81_FR_58681/page/1.svg)
![Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 58517
information you claim to be confidential Limits.’’ This guidance is intended to Dated: August 22, 2016.
with a heading or cover note that states assist applicants preparing to submit to Leslie Kux,
‘‘THIS DOCUMENT CONTAINS FDA ANDAs and prior approval Associate Commissioner for Policy.
CONFIDENTIAL INFORMATION.’’ The supplements to ANDAs for which the [FR Doc. 2016–20399 Filed 8–24–16; 8:45 am]
Agency will review this copy, including applicant is seeking approval of a new BILLING CODE 4164–01–P
the claimed confidential information, in strength of the drug product. The
its consideration of comments. The guidance highlights serious deficiencies
second copy, which will have the in impurity information that may cause DEPARTMENT OF HEALTH AND
claimed confidential information FDA to RTR an ANDA. Specifically, HUMAN SERVICES
redacted/blacked out, will be available these deficiencies include: (1) Failing to
for public viewing and posted on http:// provide justification for proposed limits Food and Drug Administration
www.regulations.gov. Submit both for specified identified impurities in [Docket No. FDA–2013–N–1147]
copies to the Division of Dockets drug substances and drug products that
Management. If you do not wish your are above qualification thresholds; (2) Agency Information Collection
name and contact information to be failing to provide justification for Activities; Proposed Collection;
made publicly available, you can specified unidentified impurities that Comment Request; Preparing a Claim
provide this information on the cover are above identification thresholds; and of Categorical Exclusion or an
sheet and not in the body of your (3) proposing limits for unspecified Environmental Assessment for
comments and you must identify this impurities (e.g., any unknown impurity) Submission to the Center for Food
information as ‘‘confidential.’’ Any that are above identification thresholds. Safety and Applied Nutrition
information marked as ‘‘confidential’’ FDA evaluates each submitted ANDA AGENCY: Food and Drug Administration,
will not be disclosed except in individually to determine whether it is HHS.
accordance with 21 CFR 10.20 and other sufficiently complete to permit a
applicable disclosure law. For more ACTION: Notice.
substantive review and thus can be
information about FDA’s posting of received by FDA. The Agency cannot SUMMARY: The Food and Drug
comments to public dockets, see 80 FR receive an ANDA unless it contains the Administration (FDA or we) is
56469, September 18, 2015, or access information required under section announcing an opportunity for public
the information at: http://www.fda.gov/ 505(j) of the Federal Food, Drug, and comment on the proposed collection of
regulatoryinformation/dockets/ Cosmetic Act (21 U.S.C. 355(j)) and certain information by the Agency.
default.htm. related regulations (e.g., 21 CFR Under the Paperwork Reduction Act of
Docket: For access to the docket to 314.101(b)(1)). FDA issued the guidance 1995 (the PRA), Federal Agencies are
read background documents or the for industry ‘‘Abbreviated New Drug required to publish notice in the
electronic and written/paper comments Application Submissions—Refuse-to- Federal Register concerning each
received, go to http:// Receive Standards’’ to explain in some proposed collection of information,
www.regulations.gov and insert the detail the kind of omissions that can including each proposed extension of an
docket number, found in brackets in the lead to a RTR determination. A draft of existing collection of information, and
heading of this document, into the this guidance was published on to allow 60 days for public comment in
‘‘Search’’ box and follow the prompts September 17, 2014, with the title response to the notice. This notice
and/or go to the Division of Dockets ‘‘ANDA Submissions—Refuse to solicits comments on the information
Management, 5630 Fishers Lane, Rm. Receive for Lack of Proper Justification collection provisions of our guidance
1061, Rockville, MD 20852. of Impurity Limits.’’ Upon review of the document entitled ‘‘Preparing a Claim of
Submit written requests for single comments submitted to the draft Categorical Exclusion or an
copies of this guidance to the Division guidance, FDA removed the word Environmental Assessment for
of Drug Information, Center for Drug ‘‘proper’’ from the title to emphasize Submission to the Center for Food
Evaluation and Research, Food and that this guidance does not apply to the Safety and Applied Nutrition.’’
Drug Administration, 10001 New technical review of impurity limit DATES: Submit either electronic or
Hampshire Ave., Hillandale Building, justifications submitted in an ANDA. written comments on the collection of
4th Floor, Silver Spring, MD 20993– This guidance is being issued information by October 24, 2016.
0002. Send one self-addressed adhesive consistent with FDA’s good guidance ADDRESSES: You may submit comments
label to assist that office in processing practices regulation (21 CFR 10.115). as follows:
your requests. See the SUPPLEMENTARY The guidance represents the current
INFORMATION section for electronic thinking of FDA on ‘‘Abbreviated New Electronic Submissions
access to the guidance document. Drug Application Submissions—Refuse Submit electronic comments in the
FOR FURTHER INFORMATION CONTACT: to Receive for Lack of Justification of following way:
Elizabeth Giaquinto Friedman, Center Impurity Limits.’’ It does not establish • Federal eRulemaking Portal: http://
for Drug Evaluation and Research, Food any rights for any person and is not www.regulations.gov. Follow the
and Drug Administration, 10903 New binding on FDA or the public. You can instructions for submitting comments.
Hampshire Ave., Bldg. 75, Rm. 1670, use an alternative approach if it satisfies Comments submitted electronically,
Silver Spring, MD 20993–0002, 240– the requirements of the applicable including attachments, to http://
402–7930. statutes and regulations. www.regulations.gov will be posted to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: the docket unchanged. Because your
II. Electronic Access
comment will be made public, you are
I. Background Persons with access to the Internet solely responsible for ensuring that your
FDA is announcing the availability of may obtain the guidance at either http:// comment does not include any
a guidance for industry entitled www.fda.gov/Drugs/Guidance confidential information that you or a
‘‘Abbreviated New Drug Application ComplianceRegulatoryInformation/ third party may not wish to be posted,
Submissions—Refuse to Receive for Guidances/default.htm or http:// such as medical information, your or
Lack of Justification of Impurity www.regulations.gov. anyone else’s Social Security number, or
VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1](https://thefederalregister.org/doc/81_FR_58681/page/2.svg)
Document Created: 2016-08-25 00:35:09
Document Modified: 2016-08-25 00:35:09
| 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 of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930. | |
| FR Citation | 81 FR 58516 |
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