82_FR_43947 82 FR 43767 - Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments; Extension of Comment Period

82 FR 43767 - Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 180 (September 19, 2017)

Page Range43767-43768
FR Document2017-19904

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the public meeting on ``Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access'' for which the notice of public meeting appeared in the Federal Register of June 22, 2017. In the notice of public meeting, FDA requested comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to help ensure that the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 82 Issue 180 (Tuesday, September 19, 2017) 
[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43767-43768]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3615]


Administering the Hatch-Waxman Amendments: Ensuring a Balance 
Between Innovation and Access; Public Meeting; Request for Comments; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments; extension of 
comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the public meeting on ``Administering 
the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and 
Access'' for which the notice of public meeting appeared in the Federal 
Register of June 22, 2017. In the notice of public meeting, FDA 
requested comments concerning administration of the Hatch-Waxman 
Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
to help ensure that the intended balance between encouraging innovation 
in drug development and accelerating the availability to the public of 
lower cost alternatives to innovator drugs is maintained. The Agency is 
taking this action in response to a request for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of public 
meeting published June 22, 2017 (82 FR 28493). Submit either electronic 
or written comments by November 17, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 17, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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

[[Page 43768]]

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-N-3615 for ``Administering the Hatch-Waxman Amendments: 
Ensuring a Balance Between Innovation and Access; Public Meeting; 
Request for Comments.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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.
     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 the 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.

FOR FURTHER INFORMATION CONTACT: Philip Bonforte, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-
6980, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 22, 2017, 
FDA published a notice of public meeting with a 60-day comment period 
to request comments on the appropriate balance between encouraging 
innovation in drug development and accelerating the availability to the 
public of lower cost alternatives to innovator drugs. Interested 
persons were originally given until September 18, 2017, to comment.
    Following publication of the June 22, 2017, notice of public 
meeting with request for comments, FDA received requests to allow 
interested persons additional time to comment. The requesters asserted 
that the time period of 60 days was insufficient to respond fully to 
FDA's specific requests for comments and to allow potential respondents 
to thoroughly evaluate and address pertinent issues.
    FDA has considered the requests and is extending the comment period 
for the notice of public meeting until November 17, 2017.

    Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19904 Filed 9-18-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43767 (Response) As stated in the addition, FDA scientific experts possess wording and question order and supporting statements included in the skill and expertise in conducting such developing a statistical analysis plan. docket, FDA is working with a skilled research. Survey and focus group best FDA estimates the burden of this and experienced research contractor to practices will be used, including collection of information as follows: conduct the proposed study. In avoiding bias in questions due to TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Portion of study responses per burden per Total hours respondents responses respondent response Screening for pretest .............................................. 762 1 762 0.033 (2 minutes) ........ 25 Pretest .................................................................... 100 1 100 0.25 (15 minutes) ........ 25 Screening for main data collection ........................ 19,082 1 19,082 0.033 (2 minutes) ........ 630 Main data collection ............................................... 2,500 1 2,500 0.25 (15 minutes) ........ 625 Total ................................................................ ........................ ........................ ........................ ..................................... 1,305 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s burden estimate is based on Dated: September 14, 2017. interested persons additional time to prior experience with research that is Anna K. Abram, submit comments. similar to this proposed study. Deputy Commissioner for Policy, Planning, DATES: FDA is extending the comment Screening potential participants for the Legislation, and Analysis. period on the notice of public meeting 2 pretests will occur with 762 [FR Doc. 2017–19901 Filed 9–18–17; 8:45 am] published June 22, 2017 (82 FR 28493). respondents (487 adults and 275 BILLING CODE 4164–01–P Submit either electronic or written adolescents) identified and recruited comments by November 17, 2017. through the Internet panel. This brief ADDRESSES: You may submit comments screening will take an average of 2 DEPARTMENT OF HEALTH AND as follows. Please note that late, minutes (0.033 hours) per respondent. HUMAN SERVICES untimely filed comments will not be Each of the 2 pretests will consist of 50 considered. Electronic comments must respondents (34 adults and 16 Food and Drug Administration be submitted on or before November 17, adolescents) conducted during a single 2017. The https://www.regulations.gov session and take an average of 15 [Docket No. FDA–2017–N–3615] electronic filing system will accept minutes (0.25 hours) per respondent. comments until midnight Eastern Time Screening potential participants for the Administering the Hatch-Waxman at the end of November 17, 2017. main data collection will occur with Amendments: Ensuring a Balance Comments received by mail/hand 19,082 respondents (11,925 adults and Between Innovation and Access; delivery/courier (for written/paper 7,157 adolescents) identified and Public Meeting; Request for submissions) will be considered timely recruited through the same Internet Comments; Extension of Comment if they are postmarked or the delivery panel as used for the pretests. This brief Period service acceptance receipt is on or screening will take an average of 2 before that date. minutes (0.033 hours) per respondent. AGENCY: Food and Drug Administration, Recent national estimates of the HHS. Electronic Submissions numbers of adolescent current cigarette ACTION: Notice of public meeting; Submit electronic comments in the smokers, adolescents who are request for comments; extension of following way: susceptible to initiation of cigarette comment period. • Federal eRulemaking Portal: smoking, young adult current cigarette https://www.regulations.gov. Follow the smokers, and older adult current SUMMARY: The Food and Drug instructions for submitting comments. cigarette smokers informed the Administration (FDA or the Agency) is Comments submitted electronically, estimates of 13.9 percent qualification extending the comment period for the including attachments, to https:// rate for adults and 11.6 percent public meeting on ‘‘Administering the www.regulations.gov will be posted to qualification rate for adolescents. Hatch-Waxman Amendments: Ensuring the docket unchanged. Because your Applying these estimates and other a Balance Between Innovation and comment will be made public, you are assumptions from previous experience Access’’ for which the notice of public solely responsible for ensuring that your conducting similar studies to the meeting appeared in the Federal comment does not include any number of adolescents and adults to be Register of June 22, 2017. In the notice confidential information that you or a screened results in the desired sample of public meeting, FDA requested third party may not wish to be posted, size for the main data collection of 2,500 comments concerning administration of such as medical information, your or participants, of which 1,667 will be the Hatch-Waxman Amendments to the anyone else’s Social Security number, or asabaliauskas on DSKBBXCHB2PROD with NOTICES adults and 833 will be adolescents. The Federal Food, Drug, and Cosmetic Act confidential business information, such main data collection will occur with (the FD&C Act) to help ensure that the as a manufacturing process. Please note those 2,500 respondents during a single intended balance between encouraging that if you include your name, contact session. The main data collection will innovation in drug development and information, or other information that take an average of 15 minutes (0.25 accelerating the availability to the identifies you in the body of your hours) per respondent. The total public of lower cost alternatives to comments, that information will be estimated burden is 1,305 hours (25 innovator drugs is maintained. The posted on https://www.regulations.gov. hours + 25 hours + 630 hours + 625 Agency is taking this action in response • If you want to submit a comment hours). to a request for an extension to allow with confidential information that you VerDate Sep<11>2014 17:12 Sep 18, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1

43768 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices do not wish to be made available to the the information at: https://www.gpo.gov/ DEPARTMENT OF HEALTH AND public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- HUMAN SERVICES written/paper submission and in the 23389.pdf. manner detailed (see ‘‘Written/Paper Food and Drug Administration Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2009–D–0508] read background documents or the Written/Paper Submissions electronic and written/paper comments received, go to https:// Registration and Product Listing for Submit written/paper submissions as Owners and Operators of Domestic follows: www.regulations.gov and insert the Tobacco Product Establishments; • Mail/Hand delivery/Courier (for docket number, found in brackets in the Guidance for Industry; Availability written/paper submissions): Dockets heading of this document, into the Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers and/or go to the Dockets Management HHS. Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, ACTION: Notice of availability. • For written/paper comments Rockville, MD 20852. submitted to the Dockets Management SUMMARY: The Food and Drug Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: Administration (FDA) is announcing the well as any attachments, except for Philip Bonforte, Center for Drug availability of a revised guidance for information submitted, marked and Evaluation and Research, Food and industry entitled ‘‘Registration and identified, as confidential, if submitted Drug Administration, 10903 New Product Listing for Owners and as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 75, Rm. 1668, Operators of Domestic Tobacco Product Instructions: All submissions received Silver Spring, MD 20993, 240–402– Establishments.’’ This guidance is must include the Docket No. FDA– 6980, email: GenericDrugPolicy@ intended to assist persons making 2017–N–3615 for ‘‘Administering the fda.hhs.gov. tobacco product establishment Hatch-Waxman Amendments: Ensuring registration and product listing a Balance Between Innovation and SUPPLEMENTARY INFORMATION: In the submissions to FDA. Access; Public Meeting; Request for Federal Register of June 22, 2017, FDA DATES: The announcement of the Comments.’’ Received comments, those published a notice of public meeting guidance is published in the Federal filed in a timely manner (see with a 60-day comment period to Register on September 19, 2017. ADDRESSES), will be placed in the docket request comments on the appropriate ADDRESSES: You may submit either and, except for those submitted as balance between encouraging electronic or written comments on ‘‘Confidential Submissions,’’ publicly innovation in drug development and Agency guidances at any time viewable at https://www.regulations.gov accelerating the availability to the comments as follows: or at the Dockets Management Staff public of lower cost alternatives to between 9 a.m. and 4 p.m., Monday Electronic Submissions innovator drugs. Interested persons through Friday. were originally given until September Submit electronic comments in the • Confidential Submissions—To following way: submit a comment with confidential 18, 2017, to comment. • Federal eRulemaking Portal: information that you do not wish to be Following publication of the June 22, https://www.regulations.gov. Follow the made publicly available, submit your 2017, notice of public meeting with instructions for submitting comments. comments only as a written/paper request for comments, FDA received Comments submitted electronically, submission. You should submit two requests to allow interested persons including attachments, to https:// copies total. One copy will include the additional time to comment. The www.regulations.gov will be posted to information you claim to be confidential requesters asserted that the time period the docket unchanged. Because your with a heading or cover note that states of 60 days was insufficient to respond comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS fully to FDA’s specific requests for solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The comments and to allow potential comment does not include any Agency will review this copy, including respondents to thoroughly evaluate and confidential information that you or a the claimed confidential information, in address pertinent issues. third party may not wish to be posted, its consideration of comments. The such as medical information, your or second copy, which will have the FDA has considered the requests and is extending the comment period for the anyone else’s Social Security number, or claimed confidential information confidential business information, such redacted/blacked out, will be available notice of public meeting until November as a manufacturing process. Please note for public viewing and posted on 17, 2017. that if you include your name, contact https://www.regulations.gov. Submit Dated: September 14, 2017. information, or other information that both copies to the Dockets Management Anna K. Abram, identifies you in the body of your Staff. If you do not wish your name and comments, that information will be Deputy Commissioner for Policy, Planning, contact information to be made publicly Legislation, and Analysis. posted on https://www.regulations.gov. available, you can provide this [FR Doc. 2017–19904 Filed 9–18–17; 8:45 am] • If you want to submit a comment information on the cover sheet and not with confidential information that you BILLING CODE 4164–01–P asabaliauskas on DSKBBXCHB2PROD with NOTICES in the body of your comments and you do not wish to be made available to the must identify this information as public, submit the comment as a ‘‘confidential.’’ Any information marked written/paper submission and in the as ‘‘confidential’’ will not be disclosed manner detailed (see ‘‘Written/Paper except in accordance with 21 CFR 10.20 Submissions’’ and ‘‘Instructions’’). and other applicable disclosure law. For more information about FDA’s posting Written/Paper Submissions of comments to public dockets, see 80 Submit written/paper submissions as FR 56469, September 18, 2015, or access follows: VerDate Sep<11>2014 17:12 Sep 18, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1


Document Created: 2018-10-24 14:18:19
Document Modified: 2018-10-24 14:18:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meeting; request for comments; extension of comment period.
DatesFDA is extending the comment period on the notice of public meeting published June 22, 2017 (82 FR 28493). Submit either electronic or written comments by November 17, 2017.
ContactPhilip Bonforte, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402- 6980, email: [email protected]
FR Citation82 FR 43767 
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