80 FR 67409 - Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 211 (November 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 211 (November 2, 2015)
| Page Range | 67409-67411 | |
| FR Document | 2015-27816 |
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)] [Notices] [Pages 67409-67411] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27816] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. [[Page 67410]] ACTION: Notice of Availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled ``Draft Guidance on Progesterone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel. 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 4, 2016.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-2007-D-0369 for Bioequivalence Recommendations for Progesterone; 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: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for progesterone gel. FDA initially approved new drug application 020701 for Crinone gel in July 1997. There are no approved ANDAs for this product. We are now issuing a draft guidance for industry on BE recommendations for generic progesterone gel (``Draft Guidance on Progesterone''). In June 2013, Watson Laboratories, manufacturer of the reference listed drug, Crinone, submitted a citizen petition requesting that FDA require ANDA applicants to demonstrate bioequivalence to Crinone with studies that include pharmacokinetic and clinical endpoint studies and to issue a draft BE guidance identifying these studies. (FDA notes that subsequent to submission of the petition, Watson Laboratories informed FDA that the company has changed its name to Actavis Labs UT Inc.) FDA has reviewed the issues raised in the petition and is responding to the petition (Docket No. FDA-2013-P-0664, available at http://www.regulations.gov). This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). [[Page 67411]] The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs for progesterone gel. 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 document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27816 Filed 10-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices 67409
Division of Dockets Management described FDA’s intention with regard these requirements by November 1,
between 9 a.m. and 4 p.m., Monday to enforcement of the product tracing 2015. Thus, FDA recognizes that these
through Friday. information requirements under section dispensers continue to need additional
• Confidential Submissions—To 582(d)(1) of the FD&C Act (21 U.S.C. time to work with trading partners to
submit a comment with confidential 360eee–1(d)(1)). FDA is issuing a ensure that the product tracing
information that you do not wish to be revised guidance that extends the information required by section 582 of
made publicly available, submit your compliance policy described in the the FD&C Act is captured and
comments only as a written/paper guidance. We are issuing this guidance maintained by dispensers. In light of
submission. You should submit two consistent with our good guidance these concerns, FDA does not intend to
copies total. One copy will include the practices regulation (21 CFR 10.115). take action against dispensers who,
information you claim to be confidential We are implementing this guidance prior to March 1, 2016: (1) Accept
with a heading or cover note that states without prior public comment because ownership of product without receiving
‘‘THIS DOCUMENT CONTAINS we have determined that prior public product tracing information, prior to or
CONFIDENTIAL INFORMATION.’’ The participation is not feasible or at the time of a transaction, as required
Agency will review this copy, including appropriate (21 CFR 10.115(g)(2)). We by section 582(d)(1)(A)(i) of the FD&C
the claimed confidential information, in made this determination because this Act or (2) do not capture and maintain
its consideration of comments. The guidance document provides the product tracing information, as
second copy, which will have the information pertaining to certain required by section 582(d)(1)(A)(iii) of
claimed confidential information statutory requirements that took effect the FD&C Act. This compliance policy
redacted/blacked out, will be available on July 1, 2015, regarding the provisions does not extend to other requirements of
for public viewing and posted on to provide, capture, and maintain the FD&C Act applicable to dispensers
http://www.regulations.gov. Submit product tracing information under and other trading partners, including
both copies to the Division of Dockets section 582(d)(1) of the FD&C Act, and those in section 582 of the FD&C Act,
Management. If you do not wish your it extends a compliance policy that such as verification related to suspect
name and contact information to be would have expired for transactions and illegitimate product (including
made publicly available, you can after November 1, 2015. It is important quarantine, investigation, notification,
provide this information on the cover that FDA provide this information and recordkeeping) and requirements
sheet and not in the body of your before that date. Although this guidance related to engaging in transactions only
comments and you must identify this document is immediately in effect, it with authorized trading partners. The
information as ‘‘confidential.’’ Any remains subject to comment in guidance document explains the scope
information marked as ‘‘confidential’’ accordance with the Agency’s good of the compliance policy in further
will not be disclosed except in guidance practices (21 CFR detail.
accordance with 21 CFR 10.20 and other 10.115(g)(3)). The guidance represents the current
applicable disclosure law. For more On November 27, 2013, the DSCSA thinking of FDA on this topic. It does
information about FDA’s posting of (Title II of Pub. L. 113–54) was signed not establish any rights for any person
comments to public dockets, see 80 FR into law. Section 202 of DSCSA adds and is not binding on FDA or the public.
56469, September 18, 2015, or access sections 581 and 582 to the FD&C Act, You can use an alternative approach if
the information at: http://www.fda.gov/ which set forth new definitions and it satisfies the requirements of the
regulatoryinformation/dockets/ requirements for the tracing of products applicable statutes and regulations.
default.htm. through the pharmaceutical distribution
II. Electronic Access
Docket: For access to the docket to supply chain. Starting in 2015, trading
partners (manufacturers, wholesale Persons with access to the Internet
read background documents or the may obtain the document at http://
electronic and written/paper comments distributors, dispensers, and
repackagers) were required under www.fda.gov/Drugs/Guidance
received, go to http:// ComplianceRegulatoryInformation/
sections 582(b)(1), (c)(1), (d)(1), and
www.regulations.gov and insert the Guidances/default.htm, http://
(e)(1) of the FD&C Act to exchange
docket number, found in brackets in the www.fda.gov/BiologicsBloodVaccines/
product tracing information when
heading of this document, into the GuidanceComplianceRegulatory
engaging in transactions involving
‘‘Search’’ box and follow the prompts Information/Guidances/default.htm, or
certain prescription drugs. For
and/or go to the Division of Dockets http://www.regulations.gov.
dispensers, requirements for the tracing
Management, 5630 Fishers Lane, Rm.
of products through the pharmaceutical Dated: October 27, 2015.
1061, Rockville, MD 20852.
distribution supply chain under section Leslie Kux,
FOR FURTHER INFORMATION CONTACT: 582(d)(1) of the FD&C Act took effect on Associate Commissioner for Policy.
Office of Compliance, Center for Drug July 1, 2015. FDA published a guidance
Evaluation and Research, Food and [FR Doc. 2015–27841 Filed 10–30–15; 8:45 am]
document on July 6, 2015, stating that
Drug Administration, 10903 New BILLING CODE 4164–01–P
it does not intend to take action against
Hampshire Ave., Silver Spring, MD dispensers who, prior to November 1,
20993–0002, 301–796–3130, 2015, (1) accept ownership of product
drugtrackandtrace@fda.hhs.gov. DEPARTMENT OF HEALTH AND
without receiving the product tracing HUMAN SERVICES
SUPPLEMENTARY INFORMATION: information, as required by section
asabaliauskas on DSK5VPTVN1PROD with NOTICES
582(d)(1)(A)(i) of the FD&C Act, or (2) Food and Drug Administration
I. Background
do not capture and maintain the product
On July 6, 2015, FDA published a tracing information, as required by [Docket No. FDA–2007–D–0369]
Notice of Availability in the Federal section 582(d)(1)(A)(iii) of the FD&C Bioequivalence Recommendations for
Register (80 FR 38449) announcing a Act. Progesterone; Draft Guidance for
guidance document entitled ‘‘DSCSA Some dispensers—primarily smaller,
Industry; Availability
Implementation: Product Tracing independent pharmacies and health
Requirements for Dispensers— systems—have expressed concern that AGENCY: Food and Drug Administration,
Compliance Policy.’’ The guidance they will be unable to comply with HHS.
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![Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices 67411
The draft guidance, when finalized, will 10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m.,
represent the Agency’s current thinking considers your comment of this draft Monday through Friday.
on the design of BE studies to support guidance before it begins work on the • Confidential Submissions—To
ANDAs for progesterone gel. It does not final version of the guidance, submit submit a comment with confidential
establish any rights for any person and either electronic or written comments information that you do not wish to be
is not binding on FDA or the public. on the draft guidance by December 17, made publicly available, submit your
You can use an alternative approach if 2015. comments only as a written/paper
it satisfies the requirements of the ADDRESSES: You may submit comments submission. You should submit two
applicable statutes and regulations. as follows: copies total. One copy will include the
information you claim to be confidential
II. Electronic Access Electronic Submissions with a heading or cover note that states
Persons with access to the Internet Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
may obtain the document at either following way: CONFIDENTIAL INFORMATION’’. The
http://www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: http:// Agency will review this copy, including
ComplianceRegulatoryInformation/ www.regulations.gov. Follow the the claimed confidential information, in
Guidances/default.htm or http:// instructions for submitting comments. its consideration of comments. The
www.regulations.gov. Comments submitted electronically, second copy, which will have the
Dated: October 27, 2015. including attachments, to http:// claimed confidential information
Leslie Kux, www.regulations.gov will be posted to redacted/blacked out, will be available
Associate Commissioner for Policy. the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are http://www.regulations.gov. Submit
[FR Doc. 2015–27816 Filed 10–30–15; 8:45 am]
solely responsible for ensuring that your both copies to the Division of Dockets
BILLING CODE 4164–01–P
comment does not include any Management. If you do not wish your
confidential information that you or a name and contact information to be
DEPARTMENT OF HEALTH AND third party may not wish to be posted, made publicly available, you can
HUMAN SERVICES such as medical information, your or provide this information on the cover
anyone else’s Social Security number, or sheet and not in the body of your
Food and Drug Administration confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
[Docket No. FDA–2015–D–3787] information marked as ‘‘confidential’’
that if you include your name, contact
information, or other information that will not be disclosed except in
Information To Support a Claim of
identifies you in the body of your accordance with 21 CFR 10.20 and other
Electromagnetic Compatibility of
comments, that information will be applicable disclosure law. For more
Electrically Powered Medical Devices;
posted on http://www.regulations.gov. information about FDA’s posting of
Draft Guidance for Industry and Food
and Drug Administration Staff; • If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
Availability
do not wish to be made available to the the information at: http://www.fda.gov/
AGENCY: Food and Drug Administration, public, submit the comment as a regulatoryinformation/dockets/
HHS. written/paper submission and in the default.htm.
ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug electronic and written/paper comments
Administration (FDA or Agency) is Written/Paper Submissions received, go to http://
announcing the availability of the draft Submit written/paper submissions as www.regulations.gov and insert the
guidance entitled ‘‘Information to follows: docket number, found in brackets in the
Support a Claim of Electromagnetic • Mail/Hand delivery/Courier (for heading of this document, into the
Compatibility (EMC) of Electrically- written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Powered Medical Devices.’’ This Dockets Management (HFA–305), Food and/or go to the Division of Dockets
guidance describes the types of and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
information that should be provided to Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
support a claim of electromagnetic • For written/paper comments An electronic copy of the guidance
compatibility (EMC) in a premarket submitted to the Division of Dockets document is available for download
submission for an electrically powered Management, FDA will post your from the Internet. See the
medical device. Electromagnetic comment, as well as any attachments, SUPPLEMENTARY INFORMATION section for
disturbance is electronic product except for information submitted, information on electronic access to the
radiation that may interfere with the marked and identified, as confidential, guidance. Submit written requests for a
performance of an electrically powered if submitted as detailed in single hard copy of the draft guidance
medical device in its intended ‘‘Instructions.’’ document entitled ‘‘Information to
environment (i.e., cause an Instructions: All submissions received Support a Claim of Electromagnetic
electromagnetic interference (EMI)). must include the Docket No. FDA– Compatibility (EMC) of Electrically-
EMC assessment helps to ensure that a 2015–D–3787 for ‘‘Information to Powered Medical Devices’’ to the Office
asabaliauskas on DSK5VPTVN1PROD with NOTICES
device is able to function in its intended Support a Claim of Electromagnetic of the Center Director, Guidance and
environment without introducing Compatibility (EMC) of Electrically- Policy Development, Center for Devices
excessive electromagnetic disturbances Powered Medical Devices.’’ Received and Radiological Health, Food and Drug
that might interfere with other devices. comments will be placed in the docket Administration, 10903 New Hampshire
This draft guidance is not final nor is it and, except for those submitted as Ave., Bldg. 66, Rm. 5431, Silver Spring,
in effect at this time. ‘‘Confidential Submissions,’’ publicly MD 20993–0002. Send one self-
DATES: Although you can comment on viewable at http://www.regulations.gov addressed adhesive label to assist that
any guidance at any time (see 21 CFR or at the Division of Dockets office in processing your request.
VerDate Sep<11>2014 18:55 Oct 30, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\02NON1.SGM 02NON1](https://thefederalregister.org/doc/80_FR_67620/page/3.svg)
Document Created: 2018-03-01 11:29:32
Document Modified: 2018-03-01 11:29:32
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments 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 January 4, 2016. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. | |
| FR Citation | 80 FR 67409 |
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