82 FR 39795 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 161 (August 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 161 (August 22, 2017)
| Page Range | 39795-39797 | |
| FR Document | 2017-17701 |
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)] [Notices] [Pages 39795-39797] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17701] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0623] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). DATES: Fax written comments on the collection of information by September 21, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0027. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Voluntary Cosmetic Registration Program--21 CFR Parts 710 and 720 OMB Control Number 0910-0027--Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us with the authority to regulate cosmetic products in the United States. Cosmetic products that are adulterated under section 601 of the FD&C Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 U.S.C. 362) may not be distributed in interstate commerce. We have developed the Voluntary Cosmetic Registration Program (VCRP) to assist us in carrying out our responsibility to regulate cosmetics. FDA is revising forms for the VCRP (Forms FDA 2511, 2512, 2512a, and 2514) currently approved under OMB control number 0910-0027, ``Voluntary Cosmetic Registration Program,'' for the following reasons: (1) Modernizing the forms; (2) Making it easier for filers who complete the forms; and (3) reducing the time it will take FDA to review each submission. In addition, Form FDA 2514 will be eliminated as it duplicates information that is currently located on Form FDA 2512. FDA requests PRA approval for the proposed changes to these forms, and for the elimination of Form FDA 2514. Participation in the VCRP is voluntary under provisions found in sections parts 710 and 720 (21 CFR parts 710 and 720). Participants have the option of submitting information via paper forms or via the online interface. The term ``form'' refers to both the paper form and the online system. Currently, in part 710, we request that establishments that manufacture or package cosmetic products voluntarily register with us using Form FDA 2511 entitled ``Registration of Cosmetic Product Establishment.'' The online version of Form FDA 2511 is available on our VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We strongly encourage online registration with Form FDA 2511 because it is faster and more efficient for the filer and the Agency. A registering facility will receive confirmation of online registration, including a registration number by email. The online system also allows for amendments to past submissions. Because registration of cosmetic product establishments is not mandatory, voluntary registration provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. We place the registration information in a computer database and use the information to generate lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. Registration is permanent, although we request that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes. FDA's proposed changes to the forms through the use of an electronic submission system have been designed to make it easier for participants to provide information to FDA about their products. The system also assists participants, through interactive question and response scenarios, to identify submissions that will be ineligible to be accepted in VCRP because they do not meet parts 710 and 720 requirements. The electronic submission system is expected to reduce burden currently associated with the manual identification process for filers and FDA. The rejection rate for ineligible submissions when using the current forms is high: 51 percent for new accounts, 43 percent for Form FDA 2511 registrations, and 7 percent for Form FDA 2512 filings (2010-2016). The revised forms include the addition of links between Forms FDA 2511 and 2512, clarification of what information should be entered onto the forms, additional self-identifying fields, removal of certain duplicative fields, and the deletion of Form FDA 2514. These changes are needed because both VCRP voluntary filer participation and FDA resources required to administer VCRP have increased significantly since 2014 (i.e., increases in new accounts (156 percent), Form FDA 2511 registrations (405 percent), Form FDA 2512 filings (67 percent), and FDA review hours (59 percent) in 2016.) FDA's current process confirms that each submission meets the requirements established in parts 710 and 720 by using a manual process for both filers and FDA reviewers that may result in a long waiting period where filers must wait and respond to questions generated by FDA, which may result in a high rejection rate. FDA projects a significant reduction in rejection rates when using the revised forms. Examples of possible burden savings for participants and FDA include: (1) Form FDA 2511 asks filers if they are a manufacturer or packer; however, in the past, distributors and retailers have checked these boxes in error when neither applies to them because there are no distributor or retailer checkboxes on Form FDA 2511. Retailers have also filed Form FDA 2512 in error even though only manufacturers, packers, [[Page 39796]] and distributors are permitted to do so. To correct these issues, FDA revised Form FDA 2511 by updating the field that allows filers to indicate the ``TYPE OF ESTABLISHMENT: MANUFACTURER/PACKER/OTHER (Distributor or Retailer)'' and updating the field on Form FDA 2512 allowing the filer to indicate ``WHO IS FILING THIS STATEMENT: MANUFACTURER/PACKER/DISTRIBUTOR/OTHER (Retailer).'' (2) FDA revised Form FDA 2511 and added questions asking, ``Are you the owner or operator of this facility?'' and ``Is the address on this form the location of a cosmetic manufacturing and/or packing facility?'' (3) FDA also revised Form FDA 2512 and added questions asking, ``Is this product currently commercially distributed (annual sales exceed $1,000) in the United States?'', ``PRODUCT WEBSITE'', and ``Attach images of the front and back product labels to this form'' to ensure that only cosmetics in commercial distribution in the United States are filed in the VCRP. (4) FDA linked Forms FDA 2511 and 2512 to reduce burden to filers who create multiple copies of Form FDA 2512 that share the same establishment addresses. (5) FDA clarified the information that should be included on the forms by attaching simplified instructions and a link to VCRP online on Forms FDA 2511, 2512, and 2512a and adding titles and locations of various fields throughout Forms FDA 2511, 2512, and 2512a. We also added self-identifying information such as phone number, email, and alternative authorized individual fields to Forms FDA 2511 and 2512 to facilitate communication with the filers. (6) We also removed fields that have no modern use or request redundant information in multiple locations. (7) We removed Form FDA 2514 in its entirety due to redundancy. (As noted, filers may notify FDA that they are discontinuing a cosmetic product formulation on Form FDA 2512). FDA's online filing system is available on FDA's VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. The online filing system contains the online versions of Forms FDA 2511, 2512, and 2512a. We place cosmetic product filing information in a computer database and use the information when FDA receives inquiries about cosmetics marketed in the United States. Because filing of cosmetic product formulations is not mandatory, voluntary filings with FDA provide us with the best information available about cosmetic products, ingredients, frequency of use, businesses engaged in the manufacture and distribution of cosmetics, and approximate rates of product discontinuance and formula modifications. The information assists our scientists in evaluating reports of adverse events submitted via MedWatch and Field Operators (FACTS). We also use the information in identifying future research projects, to evaluate the levels and safety of certain ingredients in cosmetics. Links to explanations of the revisions to Forms FDA 2511, 2512, and 2512a and instructions are available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm and entitled ``Voluntary Cosmetic Registration Program.'' In the Federal Register of May 31, 2017 (82 FR 24977), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. Two comments were received. One comment appeared to be a submission under 21 CFR 10.35 and 10.40(b)(3) and therefore is not addressed here. The second comment offered suggestions that FDA might consider regarding the content and format of reporting elements, but made no suggestion for FDA to revise its burden estimate. Accordingly, while the Agency is currently reviewing these suggestions to determine whether our current IT system may be upgraded to the benefit of respondents, we retain the burden estimate from our 60-day notice. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Total 21 CFR Section or part Form No. respondents per annual Average burden per response hours respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Part 710 (registrations)............. FDA 2511 \2\.............. 934 1 934 0.20 (12 minutes)................ 187 720.1 through 720.4 (new submissions) FDA 2512 \3\.............. 7,108 1 7,108 0.33 (20 minutes)................ 2,346 720.6 (amendments)................... FDA 2512.................. 4,049 1 4,049 0.17 (10 minutes)................ 688 720.6 (notices of discontinuance).... FDA 2512.................. 95 1 95 0.10 (6 minutes)................. 10 720.8 (requests for confidentiality). .......................... 1 1 1 2................................ 2 ------------------------------------------------------------------------- Total............................ .......................... ........... ............ ........... ................................. 3,233 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. \3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We base our estimate of the total annual responses on paper and online submissions received during calendar year 2016. We base our estimate of the hours per response upon information from cosmetic industry personnel and FDA experience entering data submitted on paper Forms FDA 2511, 2512, and 2512a into the online system. We estimate that, annually, 934 establishments that manufacture or package cosmetic products will each submit 1 registration on Form FDA 2511, for a total of 934 annual responses. Each submission is estimated to take 0.20 hour per response for a total of 186.8 hours, rounded to 187. The number of Form FDA 2511 submissions has increased 405 percent compared to 2014 and we have no indication that this submission rate will stop increasing. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 7,108 ingredient statements for new or amended submissions on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33 hour per response for a total of 2345.64 hours, rounded to 2,346. We estimate the number of Form FDA 2512 submissions to increase 67 percent compared to 2014 and we have no indication that this submission rate will stop increasing. We estimate that, annually, firms that manufacture, pack, or distribute [[Page 39797]] cosmetics will file 4,049 amendments to product formulations on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour per response for a total of 688.33 hours, rounded to 688. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 95 notices of discontinuance on Form FDA 2512. Each submission is estimated to take 0.10 hour per response for a total of 9.5 hours, rounded to 10. We estimate that, annually, one firm will file one request for confidentiality. Each such request is estimated to take 2 hours to prepare for a total of 2 hours. Thus, the total estimated hour burden for this information collection is 3,233 hours. Dated: August 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17701 Filed 8-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39795
for labeling are included in the estimate Voluntary Cosmetic Registration computer database and use the
for § 71.1. Also, because labeling Program—21 CFR Parts 710 and 720 information to generate lists for
requirements under parts 172, 173, 179, OMB Control Number 0910–0027— distributing regulatory information and
and 180 for particular food additives Extension for inviting firms to participate in
involve information required as part of workshops on topics in which they may
the FAP safety review process under The Federal Food, Drug, and Cosmetic be interested. Registration is permanent,
§ 171.1, the burden hours for labeling Act (the FD&C Act) provides us with the although we request that respondents
are included in the estimate for § 171.1. authority to regulate cosmetic products submit an amended Form FDA 2511 if
in the United States. Cosmetic products any of the originally submitted
Dated: August 17, 2017. that are adulterated under section 601 of information changes.
Leslie Kux, the FD&C Act (21 U.S.C. 361) or FDA’s proposed changes to the forms
Associate Commissioner for Policy. misbranded under section 602 of the through the use of an electronic
[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am] FD&C Act (21 U.S.C. 362) may not be submission system have been designed
BILLING CODE 4164–01–P distributed in interstate commerce. We to make it easier for participants to
have developed the Voluntary Cosmetic provide information to FDA about their
Registration Program (VCRP) to assist us products. The system also assists
DEPARTMENT OF HEALTH AND in carrying out our responsibility to participants, through interactive
HUMAN SERVICES regulate cosmetics. question and response scenarios, to
FDA is revising forms for the VCRP identify submissions that will be
Food and Drug Administration (Forms FDA 2511, 2512, 2512a, and ineligible to be accepted in VCRP
2514) currently approved under OMB because they do not meet parts 710 and
[Docket No. FDA–2010–N–0623] control number 0910–0027, ‘‘Voluntary 720 requirements. The electronic
Cosmetic Registration Program,’’ for the submission system is expected to reduce
Agency Information Collection following reasons: (1) Modernizing the burden currently associated with the
Activities; Submission for Office of forms; (2) Making it easier for filers who manual identification process for filers
Management and Budget Review; complete the forms; and (3) reducing the and FDA. The rejection rate for
Comment Request; Voluntary time it will take FDA to review each ineligible submissions when using the
Cosmetic Registration Program submission. In addition, Form FDA current forms is high: 51 percent for
2514 will be eliminated as it duplicates new accounts, 43 percent for Form FDA
AGENCY: Food and Drug Administration, information that is currently located on
HHS. 2511 registrations, and 7 percent for
Form FDA 2512. FDA requests PRA Form FDA 2512 filings (2010–2016).
ACTION: Notice. approval for the proposed changes to The revised forms include the
these forms, and for the elimination of addition of links between Forms FDA
SUMMARY: The Food and Drug
Form FDA 2514. 2511 and 2512, clarification of what
Administration (FDA, Agency, or we) is Participation in the VCRP is voluntary
announcing that a proposed collection information should be entered onto the
under provisions found in sections parts forms, additional self-identifying fields,
of information has been submitted to the 710 and 720 (21 CFR parts 710 and 720). removal of certain duplicative fields,
Office of Management and Budget Participants have the option of and the deletion of Form FDA 2514.
(OMB) for review and clearance under submitting information via paper forms These changes are needed because both
the Paperwork Reduction Act of 1995 or via the online interface. The term VCRP voluntary filer participation and
(PRA). ‘‘form’’ refers to both the paper form and FDA resources required to administer
DATES: Fax written comments on the the online system. VCRP have increased significantly since
collection of information by September Currently, in part 710, we request that 2014 (i.e., increases in new accounts
21, 2017. establishments that manufacture or (156 percent), Form FDA 2511
ADDRESSES: To ensure that comments on package cosmetic products voluntarily registrations (405 percent), Form FDA
the information collection are received, register with us using Form FDA 2511 2512 filings (67 percent), and FDA
OMB recommends that written entitled ‘‘Registration of Cosmetic review hours (59 percent) in 2016.)
comments be faxed to the Office of Product Establishment.’’ The online FDA’s current process confirms that
Information and Regulatory Affairs, version of Form FDA 2511 is available each submission meets the requirements
OMB, Attn: FDA Desk Officer, Fax: 202– on our VCRP Web site at https:// established in parts 710 and 720 by
395–7285, or emailed to oira_ www.fda.gov/Cosmetics/Registration using a manual process for both filers
submission@omb.eop.gov. All Program/default.htm. We strongly and FDA reviewers that may result in a
comments should be identified with the encourage online registration with Form long waiting period where filers must
OMB control number 0910–0027. Also FDA 2511 because it is faster and more wait and respond to questions generated
include the FDA docket number found efficient for the filer and the Agency. A by FDA, which may result in a high
in brackets in the heading of this registering facility will receive rejection rate. FDA projects a significant
document. confirmation of online registration, reduction in rejection rates when using
including a registration number by the revised forms. Examples of possible
FOR FURTHER INFORMATION CONTACT: Ila email. The online system also allows for burden savings for participants and FDA
S. Mizrachi, Office of Operations, Food amendments to past submissions. include:
and Drug Administration, Three White Because registration of cosmetic (1) Form FDA 2511 asks filers if they
Flint North, 10A63, 11601 Landsdown product establishments is not are a manufacturer or packer; however,
sradovich on DSK3GMQ082PROD with NOTICES
St., North Bethesda, MD 20852, 301– mandatory, voluntary registration in the past, distributors and retailers
796–7726, PRAStaff@fda.hhs.gov. provides FDA with the best information have checked these boxes in error when
SUPPLEMENTARY INFORMATION: In available about the locations, business neither applies to them because there
compliance with 44 U.S.C. 3507, FDA trade names, and types of activity are no distributor or retailer checkboxes
has submitted the following proposed (manufacturing or packaging) of on Form FDA 2511. Retailers have also
collection of information to OMB for cosmetic product establishments. We filed Form FDA 2512 in error even
review and clearance. place the registration information in a though only manufacturers, packers,
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![Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39797
cosmetics will file 4,049 amendments to 183(a)(1) of the Medicare Improvements (1) May assist consumers and patients in
product formulations on Forms FDA for Patients and Providers Act of 2008 making informed health care decisions;
2512 and FDA 2512a. Each submission (MIPPA) (Pub. L. 110–275), requires the (2) address health disparities across
is estimated to take 0.17 hour per Secretary to identify and have in effect groups and areas; and (3) address the
response for a total of 688.33 hours, a contract with a consensus-based entity continuum of care a patient receives,
rounded to 688. We estimate that, (CBE) to perform multiple duties including across multiple providers,
annually, firms that manufacture, pack, described in subsection (b) that are practitioners and settings.
or distribute cosmetics will file 95 designed to help improve performance Endorsement of Measures. The CBE is
notices of discontinuance on Form FDA measurement. The duties described in required to provide for the endorsement
2512. Each submission is estimated to subsection (b) originally included a of standardized health care performance
take 0.10 hour per response for a total priority setting process, measure measures. This process must consider
of 9.5 hours, rounded to 10. We estimate endorsement, measure maintenance, whether measures are evidence-based,
that, annually, one firm will file one electronic health record promotion, and reliable, valid, verifiable, relevant to
request for confidentiality. Each such the preparation of an annual Report to enhanced health outcomes, actionable at
request is estimated to take 2 hours to Congress and the Secretary. Section the caregiver level, feasible to collect
prepare for a total of 2 hours. Thus, the 3003(b) of the Patient Protection and and report, responsive to variations in
total estimated hour burden for this Affordable Care Act (Pub. L. 111–148) as patient characteristics such as health
information collection is 3,233 hours. amended by the Health Care and status, language capabilities, race or
Education Reconciliation Act (Pub. L. ethnicity, and income level and
Dated: August 17, 2017.
111–152) (collectively, the Affordable consistent across types of health care
Leslie Kux, Care Act) expanded the duties of the providers, including hospitals and
Associate Commissioner for Policy. CBE to require the CBE to review and, physicians.
[FR Doc. 2017–17701 Filed 8–21–17; 8:45 am] as appropriate, endorse the episode Maintenance of CBE Endorsed
BILLING CODE 4164–01–P grouper developed by the Secretary Measures. The CBE is required to
under the Physician Feedback Program. establish and implement a process to
Section 3014(a)(1) of the Affordable ensure that endorsed measures are
DEPARTMENT OF HEALTH AND Care Act further expanded the duties to updated (or retired if obsolete) as new
HUMAN SERVICES require the CBE to convene multi- evidence is developed.
stakeholder groups to provide input on Review and Endorsement of an
[CMS–3340–N]
the selection of quality and efficiency Episode Grouper Under the Physician
Secretarial Review and Publication of measures and national priorities for Feedback Program. ‘‘Episode-based’’
the National Quality Forum Report of improvement in population health and performance measurement is an
2016 Activities to Congress and the in the delivery of health care services approach to better understanding the
Secretary of the Department of Health for consideration under the national utilization and costs associated with a
and Human Services strategy, and to transmit such input to certain condition by grouping together
the Secretary. Section 3014(a)(2) of the all the care related to that condition.
AGENCY: Office of the Secretary of Affordable Care Act expanded the ‘‘Episode groupers’’ are software tools
Health and Human Services, HHS. requirements for the annual report that that combine data to assess such
ACTION: Notice. must be submitted under section condition-specific utilization and costs
1890(b)(5)(A) of the Act. over a defined period of time. The CBE
SUMMARY: This notice acknowledges that To meet the requirements of section is required to provide for the review,
in accordance with section 1890(b)(5)(B) 1890(a) of the Act, in January of 2009, and as appropriate, endorsement of an
of the Social Security Act (the Act) the the Department of Health and Human episode grouper as developed by the
Secretary of the Department of Health Services (HHS) awarded a competitive Secretary on an expedited basis.
and Human Services (the Secretary) has contract to the National Quality Forum Convening Multi-Stakeholder Groups.
received and reviewed the National (NQF). A second, multi-year contract The CBE must convene multi-
Quality Forum (NQF) Report of 2016 was awarded to NQF after an open stakeholder groups to provide input on:
Activities to Congress and the Secretary competition in 2012. This contract (1) The selection of certain categories of
of the Department of Health and Human includes the following duties: quality and efficiency measures, from
Services submitted by the consensus- Priority Setting Process: Formulation among such measures that have been
based entity with whom the Secretary of a National Strategy and Priorities for endorsed by the entity; and such
has a contract under section 1890(a) of Health Care Performance Measurement. measures that have not been considered
the Act. The purpose of this Federal The CBE is required to synthesize for endorsement by such entity but are
Register notice is to publish the report, evidence and convene key stakeholders used or proposed to be used by the
together with the Secretary’s comments to make recommendations on an Secretary for the collection or reporting
on such report. integrated national strategy and of quality and efficiency measures; and
FOR FURTHER INFORMATION CONTACT: priorities for health care performance (2) national priorities for improvement
Sophia Chan, (410) 786–5050. measurement in all applicable settings. in population health and in the delivery
In doing so, the CBE is to give priority of health care services for consideration
I. Background to measures that: (1) Address the health under the national strategy. The CBE
The Secretary of the Department of care provided to patients with provides input on measures for use in
Health and Human Services (the certain specific Medicare programs, for
sradovich on DSK3GMQ082PROD with NOTICES
prevalent, high-cost chronic diseases;
Secretary) has long recognized that a (2) have the greatest potential for use in programs that report performance
high functioning health care system that improving quality, efficiency and information to the public, and for use in
provides higher quality care requires patient-centeredness of health care; and health care programs that are not
accurate, valid, and reliable (3) may be implemented rapidly due to included under the Act. The multi-
measurement of quality and efficiency. existing evidence, standards of care, or stakeholder groups provide input on
Section 1890(a) of the Social Security other reasons. Additionally, the CBE quality and efficiency measures for use
Act (the Act), as added by section must take into account measures that: in certain federal programs including
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Document Created: 2018-10-24 11:56:22
Document Modified: 2018-10-24 11:56:22
| 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 | Fax written comments on the collection of information by September 21, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 39795 |
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