82 FR 46075 - Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46075-46076 | |
| FR Document | 2017-21202 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46075-46076] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21202] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5767] Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the FDA an abbreviated new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA). DATES: Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5767 for ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. [[Page 46076]] 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 https://www.regulations.gov. Submit both copies to Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1672, Silver Spring, MD 20993-0002, 301-796-9291. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' In general, for FDA to approve an ANDA submitted under section 505(j) of the FD&C Act, an ANDA applicant must demonstrate, among other things, that the proposed generic drug has the ``same'' active ingredient(s) as and is bioequivalent to its reference listed drug, and that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the proposed generic drug are adequate to assure and preserve its identity, strength, quality, and purity (sections 505(j)(2)(A) and (4) (21 U.S.C. 355(j)(2)(A) and (4)) of the FD&C Act). If a person is seeking approval of a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, or teduglutide) and intends to submit an application that refers to a previously approved peptide drug product of rDNA origin, if the active ingredient in the proposed synthetic peptide drug product can be shown to be the same as the active ingredient in the peptide drug product of rDNA origin, whether the application should be submitted as an ANDA under section 505(j) of the FD&C Act or as a new drug application under section 505(b) of the FD&C Act will depend largely on the impurity profile for the synthetic peptide drug product as compared to the impurity profile for the peptide drug product of rDNA origin. Differences in impurities, particularly peptide-related impurities, may affect the safety or effectiveness of a peptide drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of rDNA origin should be submitted as an ANDA rather than an NDA. 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 on the submission of ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin. 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. This draft guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This draft 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 collection of information required under 21 CFR part 314 for the submission of NDAs and ANDAs is approved under OMB control number 0910-0001, and the submission of controlled correspondence pertaining to ANDAs is approved under OMB control number 0910-0797. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21202 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46075
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
New requests to be placed on the lists ................... 2,000 1 2,000 1 ................................ 2,000
Biennial update ........................................................ 2,000 1 2,000 0.5 (30 minutes) ........ 1,000
Occasional updates ................................................. 200 1 200 0.5 (30 minutes) ........ 100
Total .................................................................. ........................ ........................ ........................ .................................... 3,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number DEPARTMENT OF HEALTH AND instructions for submitting comments.
of manufacturers/processors that have HUMAN SERVICES Comments submitted electronically,
submitted new written requests, including attachments, to https://
biennial updates, and occasional Food and Drug Administration www.regulations.gov will be posted to
updates over the past 10 years. The the docket unchanged. Because your
[Docket No. FDA–2017–D–5767]
estimate of the number of burden hours comment will be made public, you are
it will take a manufacturer/processor to Abbreviated New Drug Applications for solely responsible for ensuring that your
gather the information needed to be Certain Highly Purified Synthetic comment does not include any
placed on the list or update its Peptide Drug Products That Refer to confidential information that you or a
information is based on FDA’s Listed Drugs of Recombinant third party may not wish to be posted,
experience with manufacturers/ Deoxyribonucleic Acid Origin; Draft such as medical information, your or
processors submitting similar requests. Guidance for Industry; Availability anyone else’s Social Security number, or
confidential business information, such
FDA believes that the information to be AGENCY: Food and Drug Administration, as a manufacturing process. Please note
submitted will be readily available to HHS. that if you include your name, contact
manufacturers/processors. This information, or other information that
ACTION: Notice of availability.
collection is also incorporating identifies you in the body of your
information collected to maintain lists SUMMARY: The Food and Drug comments, that information will be
of eligible exporters of dairy products Administration (FDA or Agency) is posted on https://www.regulations.gov.
who wish to export to the EU from OMB announcing the availability of a draft • If you want to submit a comment
control number 0910–0320, ‘‘Request for guidance for industry entitled ‘‘ANDAs with confidential information that you
Information from U.S. Processors that for Certain Highly Purified Synthetic do not wish to be made available to the
Export to the European Community.’’ Peptide Drug Products That Refer to public, submit the comment as a
FDA estimates that 2,000 firms will Listed Drugs of rDNA Origin.’’ The written/paper submission and in the
average 60 minutes (1 hour) to submit Federal Food, Drug, and Cosmetic Act manner detailed (see ‘‘Written/Paper
new requests for inclusion on the list, (FD&C Act) permits any person to Submissions’’ and ‘‘Instructions’’).
submit to the FDA an abbreviated new
2,000 firms will average 30 minutes (0.5 Written/Paper Submissions
drug application (ANDA) to seek
hour) to update their information every
approval to market a generic version of Submit written/paper submissions as
2 years, and 200 firms will average 30 a previously approved drug product.
minutes (0.5 hour) to occasionally follows:
update their information in this system.
This draft guidance is intended to assist • Mail/Hand delivery/Courier (for
potential applicants in determining written/paper submissions): Dockets
We also believe that submission via the when an application for a synthetic Management Staff (HFA–305), Food and
electronic registry system will not affect peptide drug product (specifically Drug Administration, 5630 Fishers
the burden estimates. An electronic glucagon, liraglutide, nesiritide, Lane, Rm. 1061, Rockville, MD 20852.
registry will enhance the ability of firms teriparatide, and teduglutide) that refers • For written/paper comments
to more efficiently request inclusion on to a previously approved peptide drug submitted to the Dockets Management
export lists. FDA calculates, therefore, product of recombinant Staff, FDA will post your comment, as
that the total burden for this collection deoxyribonucleic acid (rDNA) origin well as any attachments, except for
is 3,100 hours ((2,000 × 1) plus (2,000 should be submitted as an ANDA rather information submitted, marked and
× 0.5) plus (200 × 0.5)). than as new drug application (NDA). identified, as confidential, if submitted
Dated: September 28, 2017. DATES: Submit either electronic or as detailed in ‘‘Instructions.’’
Anna K. Abram, written comments on the draft guidance Instructions: All submissions received
by December 4, 2017 to ensure that the must include the Docket No. FDA–
Deputy Commissioner for Policy, Planning,
Agency considers your comment on this 2017–D–5767 for ‘‘ANDAs for Certain
Legislation, and Analysis.
draft guidance before it begins work on Highly Purified Synthetic Peptide Drug
[FR Doc. 2017–21212 Filed 10–2–17; 8:45 am]
the final version of the guidance.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Products That Refer to Listed Drugs of
BILLING CODE 4164–01–P
ADDRESSES: You may submit comments rDNA Origin.’’ Received comments will
on any guidance at any time as follows: be placed in the docket and, except for
those submitted as ‘‘Confidential
Electronic Submissions Submissions,’’ publicly viewable at
Submit electronic comments in the https://www.regulations.gov or at the
following way: Dockets Management Staff between 9
• Federal eRulemaking Portal: a.m. and 4 p.m., Monday through
https://www.regulations.gov. Follow the Friday.
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![46076 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
• Confidential Submissions—To Ave., Bldg. 1672, Silver Spring, MD requirements of the applicable statutes
submit a comment with confidential 20993–0002, 301–796–9291. and regulations. This draft guidance is
information that you do not wish to be SUPPLEMENTARY INFORMATION: not subject to Executive Order 12866.
made publicly available, submit your
I. Background II. The Paperwork Reduction Act of
comments only as a written/paper
1995
submission. You should submit two FDA is announcing the availability of
copies total. One copy will include the a draft guidance for industry entitled This draft guidance refers to
information you claim to be confidential ‘‘ANDAs for Certain Highly Purified previously approved collections of
with a heading or cover note that states Synthetic Peptide Drug Products That information that are subject to review by
‘‘THIS DOCUMENT CONTAINS Refer to Listed Drugs of rDNA Origin.’’ the Office of Management and Budget
CONFIDENTIAL INFORMATION.’’ The In general, for FDA to approve an ANDA (OMB) under the Paperwork Reduction
Agency will review this copy, including submitted under section 505(j) of the Act of 1995 (44 U.S.C. 3501–3520). The
the claimed confidential information, in FD&C Act, an ANDA applicant must collection of information required under
its consideration of comments. The demonstrate, among other things, that 21 CFR part 314 for the submission of
second copy, which will have the the proposed generic drug has the NDAs and ANDAs is approved under
claimed confidential information ‘‘same’’ active ingredient(s) as and is OMB control number 0910–0001, and
redacted/blacked out, will be available bioequivalent to its reference listed the submission of controlled
for public viewing and posted on drug, and that the methods used in, and correspondence pertaining to ANDAs is
https://www.regulations.gov. Submit the facilities and controls used for, the approved under OMB control number
both copies to Dockets Management manufacture, processing, and packing of 0910–0797.
Staff. If you do not wish your name and the proposed generic drug are adequate III. Electronic Access
contact information to be made publicly to assure and preserve its identity,
available, you can provide this strength, quality, and purity (sections Persons with access to the internet
information on the cover sheet and not 505(j)(2)(A) and (4) (21 U.S.C. may obtain the draft guidance at either
in the body of your comments and you 355(j)(2)(A) and (4)) of the FD&C Act). https://www.fda.gov/Drugs/Guidance
must identify this information as If a person is seeking approval of a ComplianceRegulatoryInformation/
‘‘confidential.’’ Any information marked synthetic peptide drug product Guidances/default.htm or https://www.
as ‘‘confidential’’ will not be disclosed (specifically glucagon, liraglutide, regulations.gov.
except in accordance with 21 CFR 10.20 nesiritide, teriparatide, or teduglutide) Dated: September 28, 2017.
and other applicable disclosure law. For and intends to submit an application Anna K. Abram,
more information about FDA’s posting that refers to a previously approved Deputy Commissioner for Policy, Planning,
of comments to public dockets, see 80 peptide drug product of rDNA origin, if Legislation, and Analysis.
FR 56469, September 18, 2015, or access the active ingredient in the proposed [FR Doc. 2017–21202 Filed 10–2–17; 8:45 am]
the information at: https://www.gpo.gov/ synthetic peptide drug product can be BILLING CODE 4164–01–P
fdsys/pkg/FR-2015-09-18/pdf/2015- shown to be the same as the active
23389.pdf. ingredient in the peptide drug product
Docket: For access to the docket to of rDNA origin, whether the application DEPARTMENT OF HEALTH AND
read background documents or the should be submitted as an ANDA under HUMAN SERVICES
electronic and written/paper comments section 505(j) of the FD&C Act or as a
received, go to https:// new drug application under section Food and Drug Administration
www.regulations.gov and insert the 505(b) of the FD&C Act will depend
docket number, found in brackets in the largely on the impurity profile for the [Docket No. FDA–2017–N–4918]
heading of this document, into the synthetic peptide drug product as
Joint Meeting of the
‘‘Search’’ box and follow the prompts compared to the impurity profile for the
Psychopharmacologic Drugs Advisory
and/or go to the Dockets Management peptide drug product of rDNA origin.
Committee and the Drug Safety and
Staff, 5630 Fishers Lane, Rm. 1061, Differences in impurities, particularly
Risk Management Advisory
Rockville, MD 20852. peptide-related impurities, may affect
Committee; Notice of Meeting;
You may submit comments on any the safety or effectiveness of a peptide
Establishment of a Public Docket;
guidance at any time (see 21 CFR drug product. This draft guidance is
Request for Comments
10.115(g)(5)). intended to assist potential applicants
in determining when an application for AGENCY: Food and Drug Administration,
Submit written requests for single a synthetic peptide drug product that HHS.
copies of the draft guidance to the refers to a previously approved peptide
Division of Drug Information, Center for ACTION: Notice; establishment of a
drug product of rDNA origin should be public docket; request for comments.
Drug Evaluation and Research, Food submitted as an ANDA rather than an
and Drug Administration, 10001 New NDA. SUMMARY: The Food and Drug
Hampshire Ave., Hillandale Building, This draft guidance is being issued Administration (FDA or Agency)
4th Floor, Silver Spring, MD 20993– consistent with FDA’s good guidance announces a forthcoming public
0002. Send one self-addressed adhesive practices regulation (21 CFR 10.115). advisory committee meeting of the
label to assist that office in processing
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The draft guidance, when finalized, will Psychopharmacologic Drugs Advisory
your requests. See the SUPPLEMENTARY represent the current thinking of FDA Committee and the Drug Safety and Risk
INFORMATION section for electronic
on the submission of ANDAs for certain Management Advisory Committee. The
access to the draft guidance document. highly purified synthetic peptide drug general function of the committee is to
FOR FURTHER INFORMATION CONTACT: Gail products that refer to listed drugs of provide advice and recommendations to
Schmerfeld, Office of Generic Drugs, rDNA origin. It does not establish any the Agency on FDA’s regulatory issues.
Center for Drug Evaluation and rights for any person and is not binding The meeting will be open to the public.
Research, Food and Drug on FDA or the public. You can use an FDA is establishing a docket for public
Administration, 10903 New Hampshire alternative approach if it satisfies the comment on this document.
VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1](https://thefederalregister.org/doc/82_FR_46265/page/2.svg)
Document Created: 2017-10-03 01:01:42
Document Modified: 2017-10-03 01:01:42
| 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 the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1672, Silver Spring, MD 20993-0002, 301-796-9291. | |
| FR Citation | 82 FR 46075 |
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