Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability, 58516-58517 [2016-20399]

Download as PDF 58516 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Instrument Center recruitment call screener (to confirm selection criteria and gain participation; assumes outreach to 5 centers for every 1 center needed) ....... Center engagement call script (to gather basic characteristics and plan steps for participation) .................................................................................. Implementation interview protocol ................................................................... Electronic cost workbook ................................................................................. Cost interview protocol .................................................................................... Web-based time-use survey ............................................................................ asabaliauskas on DSK3SPTVN1PROD with NOTICES .33 119 72 72 72 72 579 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., 4th Floor, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. 1 1 1 1 1 .75 8 6 2 .5 54 576 432 144 290 Food and Drug Administration Robert Sargis, ACF Reports Clearance Officer. [FR Doc. 2016–20386 Filed 8–24–16; 8:45 am] BILLING CODE 4184–23–P VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 [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 Food and Drug Administration, HHS. ACTION: Notice of availability. 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: SUMMARY: 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, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Total burden hours 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Average burden hours per response 360 Estimated Total Annual Burden Hours: 1,615 hours. ADDITIONAL INFORMATION: Number of responses per respondent 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 E:\FR\FM\25AUN1.SGM 25AUN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 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: 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-toReceive 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. I. Background Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. 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 VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 II. Electronic Access PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 58517 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1147] Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our guidance document entitled ‘‘Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.’’ DATES: Submit either electronic or written comments on the collection of information by October 24, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58516-58517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20399]


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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