81 FR 58517 - Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 165 (August 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 165 (August 25, 2016)
| Page Range | 58517-58519 | |
| FR Document | 2016-20369 |
[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)] [Notices] [Pages 58517-58519] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20369] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1147] Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.'' DATES: Submit either electronic or written comments on the collection of information by October 24, 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 [[Page 58518]] 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-2013-N-1147 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.'' 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition--OMB Control Number 0910-0541--Extension As an integral part of its decision making process, we are obligated under the National Environmental Policy Act of 1969 (NEPA) to consider the environmental impact of our actions, including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and health claims petitions. In 1997, we amended our regulations in part 25 (21 CFR part 25) to provide for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment (62 FR 40570, July 29, 1997). As a result of that rulemaking, we no longer routinely require submission of information about the manufacturing and production of our regulated articles. We also have eliminated the previously required Environmental Assessment (EA) and abbreviated EA formats from the amended regulations. Instead, we have provided guidance that contains sample formats to help industry submit a claim of categorical exclusion or an EA to the Center for Food Safety and Applied Nutrition (CFSAN). The guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition'' identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for our own procedures in order to ensure full compliance with the purposes and provisions of NEPA. The guidance provides information to assist in the preparation of claims of categorical exclusion and EAs for [[Page 58519]] submission to CFSAN. The following questions are covered in this guidance: (1) What types of industry-initiated actions are subject to a claim of categorical exclusion? (2) What must a claim of categorical exclusion include by regulation? (3) What is an EA? (4) When is an EA required by regulation and what format should be used? (5) What are extraordinary circumstances? and (6) What suggestions does CFSAN have for preparing an EA? Although CFSAN encourages industry to use the EA formats described in the guidance because standardized documentation submitted by industry increases the efficiency of the review process, alternative approaches may be used if these approaches satisfy the requirements of the applicable statutes and regulations. We are requesting the extension of OMB approval for the information collection provisions in the guidance. Description of Respondents: The likely respondents include businesses engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.15 (a) & (d) (to cover CE's 47 1 47 8 376 under 25.32(i))................ 25.15 (a) & (d) (to cover CE's 1 1 1 8 8 under 25.32(o))................ 25.15 (a) & (d) (to cover CE's 3 1 3 8 24 under 25.32(q))................ 25.40 (a) & (c) EA's............ 57 1 57 180 10,260 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 10,668 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimates for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for categorical exclusions listed under Sec. 25.32(i) and (q) that the Agency has received in the past 3 years. Please note that, in the past 3 years, there have been no submissions that requested an action that would have been subject to the categorical exclusion in Sec. 25.32(o). To avoid counting this burden as zero, we have estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission. The burden for submitting a categorical exclusion is captured under Sec. 25.15(a) and (c). To calculate the estimate for the hours per response values, we assumed that the information requested in this guidance for each of these three categorical exclusions is readily available to the submitter. For the information requested for the exclusion in Sec. 25.32(i), we expect that submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for attachment to the claim for categorical exclusion. We believe that this effort should take no longer than 8 hours per submission. For the information requested for the categorical exclusions in Sec. 25.32(o) and (q), the submitters will almost always merely need to copy existing documentation and attach it to the claim for categorical exclusion. We believe that collecting this information should also take no longer than 8 hours per submission. For the information requested for the environmental assessments in Sec. 25.40(a) and (c), we believe that submitters will submit an average of 57 environmental assessments annually. We estimate that each submitter will prepare an EA within 3 weeks (120 hours) and revise the EA based on Agency comments (between 40 to 60 hours), for a total preparation time of 180 hours. The burden relating to this collection has been previously approved under OMB control number 0910-0322, ``Environmental Impact Consideration--21 CFR part 25''. Upon approval of this collection of information by OMB, FDA will revise OMB control number 0910-0322 to remove the annual reporting burden for categorical exclusions and environmental assessment requests related to food additive petitions, color additive petitions, requests from exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance. The future burden for categorical exclusion or environmental assessments for these requests will be captured under OMB control number 0910-0541, this collection of information. Dated: August 19, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-20369 Filed 8-24-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 58517
information you claim to be confidential Limits.’’ This guidance is intended to Dated: August 22, 2016.
with a heading or cover note that states assist applicants preparing to submit to Leslie Kux,
‘‘THIS DOCUMENT CONTAINS FDA ANDAs and prior approval Associate Commissioner for Policy.
CONFIDENTIAL INFORMATION.’’ The supplements to ANDAs for which the [FR Doc. 2016–20399 Filed 8–24–16; 8:45 am]
Agency will review this copy, including applicant is seeking approval of a new BILLING CODE 4164–01–P
the claimed confidential information, in strength of the drug product. The
its consideration of comments. The guidance highlights serious deficiencies
second copy, which will have the in impurity information that may cause DEPARTMENT OF HEALTH AND
claimed confidential information FDA to RTR an ANDA. Specifically, HUMAN SERVICES
redacted/blacked out, will be available these deficiencies include: (1) Failing to
for public viewing and posted on http:// provide justification for proposed limits Food and Drug Administration
www.regulations.gov. Submit both for specified identified impurities in [Docket No. FDA–2013–N–1147]
copies to the Division of Dockets drug substances and drug products that
Management. If you do not wish your are above qualification thresholds; (2) Agency Information Collection
name and contact information to be failing to provide justification for Activities; Proposed Collection;
made publicly available, you can specified unidentified impurities that Comment Request; Preparing a Claim
provide this information on the cover are above identification thresholds; and of Categorical Exclusion or an
sheet and not in the body of your (3) proposing limits for unspecified Environmental Assessment for
comments and you must identify this impurities (e.g., any unknown impurity) Submission to the Center for Food
information as ‘‘confidential.’’ Any that are above identification thresholds. Safety and Applied Nutrition
information marked as ‘‘confidential’’ FDA evaluates each submitted ANDA AGENCY: Food and Drug Administration,
will not be disclosed except in individually to determine whether it is HHS.
accordance with 21 CFR 10.20 and other sufficiently complete to permit a
applicable disclosure law. For more ACTION: Notice.
substantive review and thus can be
information about FDA’s posting of received by FDA. The Agency cannot SUMMARY: The Food and Drug
comments to public dockets, see 80 FR receive an ANDA unless it contains the Administration (FDA or we) is
56469, September 18, 2015, or access information required under section announcing an opportunity for public
the information at: http://www.fda.gov/ 505(j) of the Federal Food, Drug, and comment on the proposed collection of
regulatoryinformation/dockets/ Cosmetic Act (21 U.S.C. 355(j)) and certain information by the Agency.
default.htm. related regulations (e.g., 21 CFR Under the Paperwork Reduction Act of
Docket: For access to the docket to 314.101(b)(1)). FDA issued the guidance 1995 (the PRA), Federal Agencies are
read background documents or the for industry ‘‘Abbreviated New Drug required to publish notice in the
electronic and written/paper comments Application Submissions—Refuse-to- Federal Register concerning each
received, go to http:// Receive Standards’’ to explain in some proposed collection of information,
www.regulations.gov and insert the detail the kind of omissions that can including each proposed extension of an
docket number, found in brackets in the lead to a RTR determination. A draft of existing collection of information, and
heading of this document, into the this guidance was published on to allow 60 days for public comment in
‘‘Search’’ box and follow the prompts September 17, 2014, with the title response to the notice. This notice
and/or go to the Division of Dockets ‘‘ANDA Submissions—Refuse to solicits comments on the information
Management, 5630 Fishers Lane, Rm. Receive for Lack of Proper Justification collection provisions of our guidance
1061, Rockville, MD 20852. of Impurity Limits.’’ Upon review of the document entitled ‘‘Preparing a Claim of
Submit written requests for single comments submitted to the draft Categorical Exclusion or an
copies of this guidance to the Division guidance, FDA removed the word Environmental Assessment for
of Drug Information, Center for Drug ‘‘proper’’ from the title to emphasize Submission to the Center for Food
Evaluation and Research, Food and that this guidance does not apply to the Safety and Applied Nutrition.’’
Drug Administration, 10001 New technical review of impurity limit DATES: Submit either electronic or
Hampshire Ave., Hillandale Building, justifications submitted in an ANDA. written comments on the collection of
4th Floor, Silver Spring, MD 20993– This guidance is being issued information by October 24, 2016.
0002. Send one self-addressed adhesive consistent with FDA’s good guidance ADDRESSES: You may submit comments
label to assist that office in processing practices regulation (21 CFR 10.115). as follows:
your requests. See the SUPPLEMENTARY The guidance represents the current
INFORMATION section for electronic thinking of FDA on ‘‘Abbreviated New Electronic Submissions
access to the guidance document. Drug Application Submissions—Refuse Submit electronic comments in the
FOR FURTHER INFORMATION CONTACT: to Receive for Lack of Justification of following way:
Elizabeth Giaquinto Friedman, Center Impurity Limits.’’ It does not establish • Federal eRulemaking Portal: http://
for Drug Evaluation and Research, Food any rights for any person and is not www.regulations.gov. Follow the
and Drug Administration, 10903 New binding on FDA or the public. You can instructions for submitting comments.
Hampshire Ave., Bldg. 75, Rm. 1670, use an alternative approach if it satisfies Comments submitted electronically,
Silver Spring, MD 20993–0002, 240– the requirements of the applicable including attachments, to http://
402–7930. statutes and regulations. www.regulations.gov will be posted to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: the docket unchanged. Because your
II. Electronic Access
comment will be made public, you are
I. Background Persons with access to the Internet solely responsible for ensuring that your
FDA is announcing the availability of may obtain the guidance at either http:// comment does not include any
a guidance for industry entitled www.fda.gov/Drugs/Guidance confidential information that you or a
‘‘Abbreviated New Drug Application ComplianceRegulatoryInformation/ third party may not wish to be posted,
Submissions—Refuse to Receive for Guidances/default.htm or http:// such as medical information, your or
Lack of Justification of Impurity www.regulations.gov. anyone else’s Social Security number, or
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![Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 58519
submission to CFSAN. The following have for preparing an EA? Although information collection provisions in the
questions are covered in this guidance: CFSAN encourages industry to use the guidance.
(1) What types of industry-initiated EA formats described in the guidance Description of Respondents: The
actions are subject to a claim of because standardized documentation likely respondents include businesses
categorical exclusion? (2) What must a submitted by industry increases the
engaged in the manufacture or sale of
claim of categorical exclusion include efficiency of the review process,
food, food ingredients, and substances
by regulation? (3) What is an EA? (4) alternative approaches may be used if
When is an EA required by regulation these approaches satisfy the used in materials that come into contact
and what format should be used? (5) requirements of the applicable statutes with food.
What are extraordinary circumstances? and regulations. We are requesting the We estimate the burden of this
and (6) What suggestions does CFSAN extension of OMB approval for the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section burden per Total hours
respondents per responses response
respondent
25.15 (a) & (d) (to cover CE’s under 25.32(i)) .................... 47 1 47 8 376
25.15 (a) & (d) (to cover CE’s under 25.32(o)) ................... 1 1 1 8 8
25.15 (a) & (d) (to cover CE’s under 25.32(q)) ................... 3 1 3 8 24
25.40 (a) & (c) EA’s ............................................................. 57 1 57 180 10,260
Total .............................................................................. ........................ ........................ ........................ ........................ 10,668
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and For the information requested for the DEPARTMENT OF HEALTH AND
numbers of responses are based on the environmental assessments in § 25.40(a) HUMAN SERVICES
annualized numbers of petitions and and (c), we believe that submitters will
notifications qualifying for categorical submit an average of 57 environmental Food and Drug Administration
exclusions listed under § 25.32(i) and assessments annually. We estimate that
(q) that the Agency has received in the each submitter will prepare an EA [Docket No. FDA–2016–D–1229]
past 3 years. Please note that, in the past within 3 weeks (120 hours) and revise
3 years, there have been no submissions the EA based on Agency comments Current Good Manufacturing Practice
that requested an action that would (between 40 to 60 hours), for a total Requirements for Food for Animals;
have been subject to the categorical preparation time of 180 hours. The Draft Guidance for Industry;
exclusion in § 25.32(o). To avoid Availability
burden relating to this collection has
counting this burden as zero, we have been previously approved under OMB AGENCY: Food and Drug Administration,
estimated the burden for this categorical control number 0910–0322, HHS.
exclusion at one respondent making one ‘‘Environmental Impact Consideration—
submission a year for a total of one ACTION: Notice of availability.
21 CFR part 25’’. Upon approval of this
annual submission. The burden for collection of information by OMB, FDA SUMMARY: The Food and Drug
submitting a categorical exclusion is will revise OMB control number 0910– Administration (FDA or Agency) is
captured under § 25.15(a) and (c). 0322 to remove the annual reporting announcing the availability of a draft
To calculate the estimate for the hours burden for categorical exclusions and guidance for industry #235 entitled
per response values, we assumed that environmental assessment requests ‘‘Current Good Manufacturing Practice
the information requested in this related to food additive petitions, color Requirements for Food for Animals.’’
guidance for each of these three additive petitions, requests from This draft guidance helps domestic and
categorical exclusions is readily exemption from regulation as a food foreign facilities that are required to
available to the submitter. For the additive, and submission of a food register as food facilities under the
information requested for the exclusion contact notification for a food contact Federal Food, Drug, and Cosmetic Act
in § 25.32(i), we expect that submitter substance. The future burden for (FD&C Act) determine whether and how
will need to gather information from they need to comply with the current
categorical exclusion or environmental
appropriate persons in the submitter’s good manufacturing practice
assessments for these requests will be
company and to prepare this requirements of the Current Good
captured under OMB control number Manufacturing Practice, Hazard
information for attachment to the claim
0910–0541, this collection of Analysis, and Risk-Based Preventive
for categorical exclusion. We believe
information. Controls for Food for Animals final rule.
that this effort should take no longer
than 8 hours per submission. For the Dated: August 19, 2016. DATES: Although you can comment on
asabaliauskas on DSK3SPTVN1PROD with NOTICES
information requested for the categorical Jeremy Sharp, any guidance at any time (see 21 CFR
exclusions in § 25.32(o) and (q), the Deputy Commissioner for Policy, Planning, 10.115(g)(5)), to ensure that the Agency
submitters will almost always merely Legislation, and Analysis. considers your comment on this draft
need to copy existing documentation [FR Doc. 2016–20369 Filed 8–24–16; 8:45 am] guidance before it begins work on the
and attach it to the claim for categorical BILLING CODE 4164–01–P
final version of the guidance, submit
exclusion. We believe that collecting either electronic or written comments
this information should also take no on the draft guidance by November 23,
longer than 8 hours per submission. 2016.
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Document Created: 2016-08-25 00:34:38
Document Modified: 2016-08-25 00:34:38
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by October 24, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 58517 |
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