81 FR 89950 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 239 (December 13, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 239 (December 13, 2016)
| Page Range | 89950-89951 | |
| FR Document | 2016-29776 |
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)] [Notices] [Pages 89950-89951] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29776] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0508] Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. 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-2009-D-0508 for ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product [[Page 89951]] Establishments.'' 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 this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, rm. G335, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (Sec. 10.115(g)(2)). Persons who owned or operated domestic manufacturing establishments engaged in the manufacture of newly deemed products prior to August 8, 2016, and continued to own or operate such establishment(s) on or after August 8, 2016, are required to register and submit product listing under section 905 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387e) by December 31, 2016. However, FDA is announcing that it does not intend to enforce these requirements with respect to newly deemed products provided the registration and product listing submissions are received by FDA on or before June 30, 2017. Although this guidance document is immediately effective, it remains subject to comment in accordance with FDA's GGP regulation. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) added section 905 to the FD&C Act, establishing requirements for tobacco product establishment registration and product listing. Cigarettes, cigarette tobacco, roll- your-own tobacco, and smokeless tobacco were immediately covered by FDA's tobacco product authorities in chapter IX of the FD&C Act, including section 905, when the Tobacco Control Act went into effect. As for other types of tobacco products, section 901(b) of the FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those products subject to chapter IX of the FD&C Act. Pursuant to that authority, on April 25, 2014, FDA issued a proposed rule seeking to deem all other products that meet the statutory definition of tobacco product, set forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those products) (79 FR 23142). After review and consideration of comments on the proposed rule, FDA published the final rule on May 10, 2016 (81 FR 28974) (``the deeming rule'') and it became effective on August 8, 2016. As a result, owners and operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products subject to the deeming rule are now required to comply with chapter IX of the FD&C Act, including the establishment registration and product listing requirements in section 905. The guidance addresses tobacco products that were immediately covered by FDA's tobacco product authorities under chapter IX of the FD&C Act and newly deemed tobacco products. The guidance represents the current thinking of FDA on this topic. 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in section 905 of the FD&C Act have been approved under OMB control number 0910-0650. III. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: December 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29776 Filed 12-12-16; 8:45 am] BILLING CODE 4164-01-P
![89950 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices
factor information collected through HIV, HBV, and HCV overall and by In the Federal Register of September
donor interviews of blood donor with demographic characteristics of donors 30, 2016 (81 FR 67358), FDA published
the resulting data from disease marker in the majority of blood donations a 60-day notice requesting public
testing and blood components collected collected in the country. This will be comment on the proposed collection of
by participating organizations into a accomplished by forming information. FDA received a few
research database. Following successful epidemiological databases consisting of comments from the public. FDA concurs
initiation of the risk factor interviews, harmonized operational data from ARC, with one comment that providing more
the TTIMS network is poised to be BSI, NYBC, and OneBlood. information to the blood center and
expanded to include additional blood • Analyze integrated risk factor and FDA may aid in prevention of
centers and/or re-focused on other infectious marker testing data transmission of infectious disease and is
safety threats as warranted. In this way, concurrently because when taken critical to the safety of the blood supply.
the TTIMS program will maintain together these may suggest that blood Four comments received were not
standardized, statistically and centers are not achieving the same responsive to the comment request on
scientifically robust processes for degree of success in educational efforts the four specified aspects of the
applying hemovigilance information to prevent donation by donors with risk collection of information. None of the
across blood collection organizations. behaviors across all demographic responses specifically commented on
The specific objectives are to: any of the proposed questions, nor did
• Determine current behavioral risk groups.
The respondents will be persons who they request that FDA make any other
factors associated with all HIV
donated blood in the United States and changes to the Donor Risk Assessment
infections, incident HBV, and incident
these participants will be defined as Questionnaire. Furthermore, the
HCV infections in blood donors
cases and controls. The estimated responses did not provide any data or
(including parenteral and sexual risks)
across the participating blood collection number of respondents is based on an explanation that would support a
organizations using a case-control study overall expected participation in the change regarding the information
design. risk factor survey. We estimate a case to collection requirements.
• Determine infectious disease control ratio of 1:2 (200 to 400) with a FDA estimates the burden of this
marker prevalence and incidence for 50 percent case enrollment. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual
Questionnaire/survey responses per Average burden per response Total hours
respondents responses
respondent
Cases and controls 2 ......................... 600 1 600 0.75 (45 minutes) ............................. 450
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 Cases consist of virus-positive donations, and controls represent uninfected donors.
Dated: December 8, 2016. registration and product listing comments, that information will be
Leslie Kux, submissions to FDA. posted on http://www.regulations.gov.
Associate Commissioner for Policy. DATES: Submit either electronic or • If you want to submit a comment
[FR Doc. 2016–29814 Filed 12–12–16; 8:45 am] written comments on Agency guidances with confidential information that you
BILLING CODE 4164–01–P at any time. do not wish to be made available to the
public, submit the comment as a
ADDRESSES: You may submit comments
written/paper submission and in the
as follows: manner detailed (see ‘‘Written/Paper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Electronic Submissions Submissions’’ and ‘‘Instructions’’).
Submit electronic comments in the Written/Paper Submissions
Food and Drug Administration
following way: Submit written/paper submissions as
[Docket No. FDA–2009–D–0508] • Federal eRulemaking Portal: http:// follows:
www.regulations.gov. Follow the • Mail/Hand delivery/Courier (for
Registration and Product Listing for instructions for submitting comments. written/paper submissions): Division of
Owners and Operators of Domestic Comments submitted electronically, Dockets Management (HFA–305), Food
Tobacco Product Establishment; including attachments, to http:// and Drug Administration, 5630 Fishers
Guidance for Industry; Availability www.regulations.gov will be posted to Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, the docket unchanged. Because your • For written/paper comments
HHS. comment will be made public, you are submitted to the Division of Dockets
ACTION: Notice of availability. solely responsible for ensuring that your Management, FDA will post your
comment does not include any comment, as well as any attachments,
SUMMARY: The Food and Drug confidential information that you or a except for information submitted,
pmangrum on DSK3GDR082PROD with NOTICES
Administration (FDA) is announcing the third party may not wish to be posted, marked and identified, as confidential,
availability of a revised guidance for such as medical information, your or if submitted as detailed in
industry entitled ‘‘Registration and anyone else’s Social Security number, or ‘‘Instructions.’’
Product Listing for Owners and confidential business information, such Instructions: All submissions received
Operators of Domestic Tobacco Product as a manufacturing process. Please note must include the Docket No. FDA–
Establishments.’’ This guidance is that if you include your name, contact 2009–D–0508 for ‘‘Registration and
intended to assist persons making information, or other information that Product Listing for Owners and
tobacco product establishment identifies you in the body of your Operators of Domestic Tobacco Product
VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/81_FR_90189/page/1.svg)
![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89951
Establishments.’’ Received comments information on electronic access to the Pursuant to that authority, on April 25,
will be placed in the docket and, except guidance. 2014, FDA issued a proposed rule
for those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: seeking to deem all other products that
Submissions,’’ publicly viewable at Katherine Collins, Center for Tobacco meet the statutory definition of tobacco
http://www.regulations.gov or at the Products, Food and Drug product, set forth in section 201(rr) of
Division of Dockets Management Administration, Document Control the FD&C Act (21 U.S.C. 321(rr)) (except
between 9 a.m. and 4 p.m., Monday Center, 10903 New Hampshire Ave., for accessories of those products) (79 FR
through Friday. Bldg. 71, Rm. G335, Silver Spring, MD 23142). After review and consideration
• Confidential Submissions—To 20993–0002, email: CTPRegulations@ of comments on the proposed rule, FDA
submit a comment with confidential fda.hhs.gov. published the final rule on May 10,
information that you do not wish to be SUPPLEMENTARY INFORMATION: 2016 (81 FR 28974) (‘‘the deeming
made publicly available, submit your rule’’) and it became effective on August
comments only as a written/paper I. Background
8, 2016. As a result, owners and
submission. You should submit two FDA is announcing the availability of operators of domestic establishments
copies total. One copy will include the a revised guidance for industry entitled engaged in the manufacture,
information you claim to be confidential ‘‘Registration and Product Listing for preparation, compounding, or
with a heading or cover note that states Owners and Operators of Domestic
‘‘THIS DOCUMENT CONTAINS processing of tobacco products subject
Tobacco Product Establishments.’’ This to the deeming rule are now required to
CONFIDENTIAL INFORMATION.’’ The guidance is intended to assist persons
Agency will review this copy, including comply with chapter IX of the FD&C
making tobacco product establishment Act, including the establishment
the claimed confidential information, in registration and product listing
its consideration of comments. The registration and product listing
submissions to FDA. We are issuing this
second copy, which will have the requirements in section 905. The
guidance consistent with our good
claimed confidential information guidance practices (GGP) regulation guidance addresses tobacco products
redacted/blacked out, will be available (§ 10.115 (21 CFR 10.115)). that were immediately covered by
for public viewing and posted on http:// We are implementing this guidance FDA’s tobacco product authorities
www.regulations.gov. Submit both without prior public comment because under chapter IX of the FD&C Act and
copies to the Division of Dockets we have determined that prior public newly deemed tobacco products.
Management. If you do not wish your participation is not feasible or The guidance represents the current
name and contact information to be appropriate (§ 10.115(g)(2)). Persons thinking of FDA on this topic. It does
made publicly available, you can who owned or operated domestic not establish any rights for any person
provide this information on the cover manufacturing establishments engaged and is not binding on FDA or the public.
sheet and not in the body of your in the manufacture of newly deemed You can use an alternative approach if
comments and you must identify this products prior to August 8, 2016, and it satisfies the requirements of the
information as ‘‘confidential.’’ Any continued to own or operate such applicable statutes and regulations.
information marked as ‘‘confidential’’ establishment(s) on or after August 8,
will not be disclosed except in 2016, are required to register and submit II. Paperwork Reduction Act of 1995
accordance with 21 CFR 10.20 and other product listing under section 905 of the
applicable disclosure law. For more Federal Food, Drug, and Cosmetic Act This guidance refers to previously
information about FDA’s posting of (the FD&C Act) (21 U.S.C. 387e) by approved collections of information
comments to public dockets, see 80 FR December 31, 2016. However, FDA is found in FDA regulations. These
56469, September 18, 2015, or access announcing that it does not intend to collections of information are subject to
the information at: http://www.fda.gov/ enforce these requirements with respect review by the Office of Management and
regulatoryinformation/dockets/ to newly deemed products provided the Budget (OMB) under the Paperwork
default.htm. registration and product listing Reduction Act of 1995 (44 U.S.C. 3501–
Docket: For access to the docket to submissions are received by FDA on or 3520). The collections of information in
read background documents or the before June 30, 2017. Although this section 905 of the FD&C Act have been
electronic and written/paper comments guidance document is immediately approved under OMB control number
received, go to http:// effective, it remains subject to comment 0910–0650.
www.regulations.gov and insert the in accordance with FDA’s GGP
docket number, found in brackets in the regulation. III. Electronic Access
heading of this document, into the The Family Smoking Prevention and Persons with access to the Internet
‘‘Search’’ box and follow the prompts Tobacco Control Act (Tobacco Control
may obtain an electronic version of the
and/or go to the Division of Dockets Act) (Pub. L. 111–31) added section 905
Management, 5630 Fishers Lane, Rm. guidance at either http://
to the FD&C Act, establishing
1061, Rockville, MD 20852. www.regulations.gov or http://
requirements for tobacco product
Submit written requests for single establishment registration and product www.fda.gov/TobaccoProducts/
copies of this guidance to the Center for listing. Cigarettes, cigarette tobacco, roll- Labeling/RulesRegulationsGuidance/
Tobacco Products, Food and Drug your-own tobacco, and smokeless default.htm.
Administration, Document Control tobacco were immediately covered by Dated: December 7, 2016.
pmangrum on DSK3GDR082PROD with NOTICES
Center, 10903 New Hampshire Ave., FDA’s tobacco product authorities in Leslie Kux,
Bldg. 71, rm. G335, Silver Spring, MD chapter IX of the FD&C Act, including Associate Commissioner for Policy.
20993–0002. Send one self-addressed section 905, when the Tobacco Control
[FR Doc. 2016–29776 Filed 12–12–16; 8:45 am]
adhesive label to assist that office in Act went into effect. As for other types
BILLING CODE 4164–01–P
processing your request or include a fax of tobacco products, section 901(b) of
number to which the guidance the FD&C Act (21 U.S.C. 387a(b)) grants
document may be sent. See the FDA authority to deem those products
SUPPLEMENTARY INFORMATION section for subject to chapter IX of the FD&C Act.
VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/81_FR_90189/page/2.svg)
Document Created: 2016-12-13 02:44:13
Document Modified: 2016-12-13 02:44:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: [email protected] | |
| FR Citation | 81 FR 89950 |
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