83 FR 24479 - Registration of Food Facilities: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 103 (May 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 103 (May 29, 2018)
| Page Range | 24479-24480 | |
| FR Document | 2018-11419 |
[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)] [Notices] [Pages 24479-24480] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11419] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1468] Registration of Food Facilities: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Registration of Food Facilities: What You Need To Know About the FDA Regulation-- Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of July 14, 2016, entitled ``Amendments to Registration of Food Facilities.'' The final rule amends the registration of food facilities regulations. DATES: The announcement of the guidance is published in the Federal Register on May 29, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 [[Page 24480]] 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-2018-D-1468 for ``Registration of Food Facilities: What You Need To Know About the FDA Regulation--Small Entity Compliance Guide.'' 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. 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.'' We will review this copy, including the claimed confidential information, in our 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. 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 SECG to the Office of Compliance, Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. SUPPLEMENTARY INFORMATION: I. Background The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. On October 10, 2003, we issued an interim final rule (68 FR 58894) to implement section 415 of the FD&C Act. That rule established the food facility registration regulations in part 1, subpart H (21 CFR 1.225 through 1.243). Previously, this guidance restated FDA's food facility registration regulations. This guidance also served as FDA's SECG for part 1, subpart H. The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. On July 14, 2016, we published a final rule (81 FR 45912) that amended our food facility registration regulations to reflect, among other things, the FSMA amendments to section 415 of the FD&C Act. Accordingly, FDA is revising this SECG to provide guidance intended to help small entities comply with the revised registration of food facilities requirements in part 1, subpart H. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). Although we stated that we did not believe that the final rule that amended our registration of food facilities regulations would have a significant economic impact on a substantial number of small entities, we analyzed various regulatory options to examine the impact on small entities. Consistent with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110- 28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations. The collections of information in part 1, subpart H have been approved under the Office of Management and Budget control number 0910-0502. III. Electronic Access Persons with access to the internet may obtain the SECG at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: May 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11419 Filed 5-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices 24479
goals, such as reducing new HIV be transferred to secure, encrypted data behavior related to the risk of HIV and
infections, increasing the use of servers. Data will be stored at CDC and other sexually transmitted diseases, (2)
condoms, and targeting high risk groups shared with local health departments in prior testing for HIV, (3) and use of HIV
by describing and monitoring the HIV accordance with existing data use prevention services. All persons
risk behaviors, HIV seroprevalence and agreements and the Assurance of interviewed will also be offered an HIV
incidence, and HIV prevention Confidentiality for HIV/AIDS test, and will participate in a pre-test
experiences of persons at highest risk Surveillance Data. Data will be counseling session. No other federal
for HIV infection. disseminated in aggregate through agency systematically collects this type
The Centers for Disease Control and academic and agency publications, of information from persons at risk for
Prevention request two year approval presentations, and reports. All data HIV infection. These data have
for a new information collection. Data collection and activities will be substantial impact on prevention
will be collected through anonymous, anonymous. program development and monitoring at
in-person interviews conducted with Personally identifiable information the local, state, and national levels.
persons systematically selected from (PII) is not included in the data The Burden Table below shows the
nine Metropolitan Statistical Areas collection. The CDC Privacy Officer has estimated annualized burden hours for
(MSAs) throughout the United States; assessed this package for applicability of the participants’ time. Annually, 990
these nine MSAs were chosen based on 5 U.S.C. 552a. The Privacy Act is not participants will complete an eligibility
having high HIV prevalence. A brief applicable because PII is not being screener (an average of 5 minutes to
screening interview will be used to collected under this CDC funded complete), 900 participants will
determine eligibility for participation in activity. The NHBS-Trans formative complete the Behavioral Assessment (an
the behavioral assessment. Participants interview and optional HIV testing are average of 40 minutes to complete), and
will be recruited through respondent- anonymous (neither names nor Social 900 will complete the Recruiter
driven sampling, a scientifically proven Security numbers are collected). Data Debriefing Form (an average of two
recruitment strategy for reaching that will be collected through NHBS- minutes to complete). The estimated
hidden, hard-to-reach, or stigmatized Trans, while sensitive, are not total annualized burden would be 713
populations. Interview data will be personally identifying. hours. Participation of respondents is
recorded on secure portable computers, The data from the behavioral voluntary. There are no costs to
without internet connections. Data will assessment will provide estimates of (1) respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondents Form name responses per burden
respondents response
respondent (in hours)
(in hours)
Persons Screened ............................. Eligibility Screener ........................... 990 1 5/60 83
Eligible Participant ............................. Behavioral Assessment ................... 900 1 40/60 600
Peer Recruiters ................................. Recruiter Debriefing ......................... 900 1 2/60 30
Total ........................................... .......................................................... ........................ ........................ ........................ 713
Jeffrey M. Zirger, SUMMARY: The Food and Drug • Federal eRulemaking Portal:
Acting Chief, Information Collection Review Administration (FDA or we) is https://www.regulations.gov. Follow the
Office, Office of Scientific Integrity, Office announcing the availability of a final instructions for submitting comments.
of the Associate Director for Science, Office guidance for industry entitled Comments submitted electronically,
of the Director, Centers for Disease Control ‘‘Registration of Food Facilities: What including attachments, to https://
and Prevention. You Need To Know About the FDA www.regulations.gov will be posted to
[FR Doc. 2018–11399 Filed 5–25–18; 8:45 am] Regulation—Small Entity Compliance the docket unchanged. Because your
BILLING CODE 4163–18–P Guide.’’ The small entity compliance comment will be made public, you are
guide (SECG) is intended to help small solely responsible for ensuring that your
entities comply with a final rule we comment does not include any
DEPARTMENT OF HEALTH AND issued in the Federal Register of July confidential information that you or a
HUMAN SERVICES 14, 2016, entitled ‘‘Amendments to third party may not wish to be posted,
Registration of Food Facilities.’’ The such as medical information, your or
Food and Drug Administration
final rule amends the registration of anyone else’s Social Security number, or
food facilities regulations. confidential business information, such
[Docket No. FDA–2018–D–1468] as a manufacturing process. Please note
DATES: The announcement of the
Registration of Food Facilities: What guidance is published in the Federal that if you include your name, contact
You Need To Know About the Food Register on May 29, 2018. information, or other information that
and Drug Administration Regulation; ADDRESSES: You may submit either
identifies you in the body of your
daltland on DSKBBV9HB2PROD with NOTICES
Small Entity Compliance Guide; electronic or written comments on comments, that information will be
Availability Agency guidances at any time as posted on https://www.regulations.gov.
follows: • If you want to submit a comment
AGENCY: Food and Drug Administration, with confidential information that you
HHS. Electronic Submissions
do not wish to be made available to the
Submit electronic comments in the public, submit the comment as a
ACTION: Notification of availability.
following way: written/paper submission and in the
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![24480 Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to FDA to renew such registrations every
Submissions’’ and ‘‘Instructions’’). read background documents or the other year, and provides FDA with
electronic and written/paper comments authority to suspend the registration of
Written/Paper Submissions
received, go to https:// a food facility in certain circumstances.
Submit written/paper submissions as www.regulations.gov and insert the On July 14, 2016, we published a final
follows docket number, found in brackets in the rule (81 FR 45912) that amended our
heading of this document, into the food facility registration regulations to
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets reflect, among other things, the FSMA
and/or go to the Dockets Management amendments to section 415 of the FD&C
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers Act. Accordingly, FDA is revising this
Rockville, MD 20852. SECG to provide guidance intended to
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any help small entities comply with the
• For written/paper comments guidance at any time (see 21 CFR revised registration of food facilities
submitted to the Dockets Management 10.115(g)(5)). requirements in part 1, subpart H.
Staff, FDA will post your comment, as Submit written requests for single
well as any attachments, except for copies of the SECG to the Office of We examined the economic
information submitted, marked and Compliance, Center for Food Safety and implications of the final rule as required
identified, as confidential, if submitted Applied Nutrition (HFS–800), Food and by the Regulatory Flexibility Act (5
as detailed in ‘‘Instructions.’’ Drug Administration, 5001 Campus Dr., U.S.C. 601–612). Although we stated
Instructions: All submissions received College Park, MD 20740. Send two self- that we did not believe that the final
must include the Docket No. FDA– addressed adhesive labels to assist that rule that amended our registration of
2018–D–1468 for ‘‘Registration of Food office in processing your request. See food facilities regulations would have a
Facilities: What You Need To Know the SUPPLEMENTARY INFORMATION section significant economic impact on a
About the FDA Regulation—Small for electronic access to the SECG. substantial number of small entities, we
Entity Compliance Guide.’’ Received analyzed various regulatory options to
FOR FURTHER INFORMATION CONTACT:
comments will be placed in the docket examine the impact on small entities.
Courtney Buchanan, Center for Food
and, except for those submitted as Consistent with section 212 of the Small
Safety and Applied Nutrition, Food and
‘‘Confidential Submissions,’’ publicly Business Regulatory Enforcement
Drug Administration, 5001 Campus Dr.,
viewable at https://www.regulations.gov Fairness Act (Pub. L. 104–121, as
College Park, MD 20740, 240–402–2487.
or at the Dockets Management Staff amended by Pub. L. 110–28), we are
SUPPLEMENTARY INFORMATION: making available the SECG to explain
between 9 a.m. and 4 p.m., Monday
through Friday. I. Background the actions that a small entity must take
to comply with the rule.
• Confidential Submissions—To The Public Health Security and
submit a comment with confidential Bioterrorism Preparedness and We are issuing the SECG consistent
information that you do not wish to be Response Act of 2002 (Bioterrorism Act) with our good guidance practices
made publicly available, submit your (Pub. L. 107–188) added section 415 to regulation (21 CFR 10.115(c)(2)). The
comments only as a written/paper the Federal Food, Drug, and Cosmetic SECG represents the current thinking of
submission. You should submit two Act (FD&C Act). Section 415 of the FDA on this topic. It does not establish
copies total. One copy will include the FD&C Act (21 U.S.C. 350d) requires any rights for any person and is not
information you claim to be confidential domestic and foreign facilities that binding on FDA or the public. You can
with a heading or cover note that states manufacture, process, pack, or hold use an alternative approach if it satisfies
‘‘THIS DOCUMENT CONTAINS food for human or animal consumption the requirements of the applicable
CONFIDENTIAL INFORMATION.’’ We in the United States to register with statutes and regulations. This guidance
will review this copy, including the FDA. is not subject to Executive Order 12866.
claimed confidential information, in our On October 10, 2003, we issued an II. Paperwork Reduction Act of 1995
consideration of comments. The second interim final rule (68 FR 58894) to
copy, which will have the claimed implement section 415 of the FD&C Act. The guidance refers to previously
confidential information redacted/ That rule established the food facility approved collections of information
blacked out, will be available for public registration regulations in part 1, found in FDA regulations. The
viewing and posted on https:// subpart H (21 CFR 1.225 through 1.243). collections of information in part 1,
www.regulations.gov. Submit both Previously, this guidance restated FDA’s subpart H have been approved under
copies to the Dockets Management Staff. food facility registration regulations. the Office of Management and Budget
If you do not wish your name and This guidance also served as FDA’s control number 0910–0502.
contact information to be made publicly SECG for part 1, subpart H.
III. Electronic Access
available, you can provide this The FDA Food Safety Modernization
information on the cover sheet and not Act (FSMA), enacted on January 4, Persons with access to the internet
in the body of your comments and you 2011, amended section 415 of the FD&C may obtain the SECG at either https://
must identify this information as Act to require that facilities engaged in www.fda.gov/FoodGuidances or https://
‘‘confidential.’’ Any information marked manufacturing, processing, packing, or www.regulations.gov. Use the FDA
as ‘‘confidential’’ will not be disclosed holding food for consumption in the website listed in the previous sentence
except in accordance with 21 CFR 10.20 United States submit additional to find the most current version of the
daltland on DSKBBV9HB2PROD with NOTICES
and other applicable disclosure law. For registration information to FDA, guidance.
more information about FDA’s posting including an assurance that FDA will be
Dated: May 22, 2018.
of comments to public dockets, see 80 permitted to inspect the facility at the
FR 56469, September 18, 2015, or access times and in the manner permitted by Leslie Kux,
the information at: https://www.gpo.gov/ the FD&C Act. Section 415 of the FD&C Associate Commissioner for Policy.
fdsys/pkg/FR-2015-09-18/pdf/2015- Act, as amended by FSMA, also requires [FR Doc. 2018–11419 Filed 5–25–18; 8:45 am]
23389.pdf. food facilities required to register with BILLING CODE 4164–01–P
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Document Created: 2018-05-26 00:48:02
Document Modified: 2018-05-26 00:48:02
| 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 | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on May 29, 2018. | |
| Contact | Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. | |
| FR Citation | 83 FR 24479 |
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