81 FR 12910 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 48 (March 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 48 (March 11, 2016)
| Page Range | 12910-12912 | |
| FR Document | 2016-05478 |
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)] [Notices] [Pages 12910-12912] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05478] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0221] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements 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 invites comments on the information collection provisions of the regulation requiring the manufacturer, packer, or distributor of a dietary supplement to notify us that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The notice also invites comment on a new electronic form that allows manufacturers, packers, and distributors of dietary supplements to notify us via FDA's Unified Registration and Listing System (FURLS). DATES: Submit either electronic or written comments on the collection of information by May 10, 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 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. [[Page 12911]] 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-N-0221 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements.'' 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. 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, we are publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our 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. Food Labeling; Notification Procedures for Statements on Dietary Supplements--21 CFR 101.93 OMB Control Number 0910-0331--Extension Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and its implementing regulation, 21 CFR 101.93, require that we be notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the FD&C Act. These provisions require that we be notified, with a submission about such statements, no later than 30 days after the first marketing of the dietary supplement. Information that is required in the submission includes: (1) The name and address of the manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is being made; (3) the name of the dietary ingredient or supplement that is the subject of the statement; (4) the name of the dietary supplement (including the brand name); and (5) the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. We have developed an electronic form (Form FDA 3955) that interested persons will be able to use to electronically submit their notifications to FDA via FURLS. Firms that prefer to submit a paper notification in a format of their own choosing will still have the option to do so, however. Form FDA 3955 prompts a respondent to include certain elements in their structure/function claim notification (SFCN) described in Sec. 101.93 in a standard format electronically and helps the respondent organize their SFCN to include only the information needed for our review of the claim. Note that the SFCN, whether electronic or paper, is used for all claims made pursuant to section 403(r)(6) of the FD&C Act, including nutrient deficiency claims and general well-being claims in addition to structure/function claims. The electronic form, and any optional elements that would be prepared as attachments to the form (e.g., label), can be submitted in electronic format via FURLS. Submissions of SFCNs will continue to be allowed in paper format. We use this information to evaluate whether statements made for dietary ingredients or dietary supplements are permissible under section 403(r)(6) of the FD&C Act. Draft screenshots of Form FDA 3955 and instructions are available for comment at http://www.fda.gov/Food/DietarySupplements/IndustryInfo/ucm485532.htm. Description of Respondents: Respondents to this collection of information include manufacturers, packers, or distributors of dietary supplements that bear section 403(r)(6) of the FD&C Act statements on their labels or labeling. We estimate the burden of this collection of information as follows: [[Page 12912]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 101.93........................ 2,200 1 2,200 0.75 (45 1,650 minutes). ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We believe that there will be minimal burden on the industry to generate information to meet the notification requirements of section 403(r)(6) of the FD&C Act by submitting information regarding section 403(r)(6) of the FD&C Act statements on labels or in labeling of dietary supplements. We also believe that submission via FURLS will not affect the burden estimates. We are requesting only information that is immediately available to the manufacturer, packer, or distributor of the dietary supplement that bears such a statement on its label or in its labeling. We estimate that, each year, approximately 2,200 firms will submit the information required by section 403(r)(6) of the FD&C Act. This estimate is based on the average number of notification submissions received by us in the preceding 3 years. We estimate that a firm will require 0.75 hours to gather the information needed and prepare a communication to us, for a total of 1,650 hours (2,200 x 0.75). Dated: March 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05478 Filed 3-10-16; 8:45 am] BILLING CODE 4164-01-P
![12910 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
patient expanded access requests are received for individual patient followup submissions during 2011,
provided under § 312.310(b), and the expanded access use under part 312. 2012, and 2013, FDA estimates that
requirements for requesting individual The estimates for ‘‘average burden per about 790 physicians will each use
patient expanded access for emergency response’’ were based on information Form FDA 3926 to submit 1.57 followup
use are provided under § 312.310(d). provided by CDER and other submissions per physician, for
FDA currently has OMB approval under Department of Health and Human approximately 1,241 followup responses
control number 0910–0014 for Services personnel who are familiar annually. Based on these estimates, FDA
individual patient expanded access with preparing and reviewing expanded calculates the total annual responses to
information collection under access submissions by practicing be 2,394 (1,153 requests for individual
§§ 312.305(b), 312.310(b), and physicians. patient expanded access and 1,241
312.310(d). The submission Based on data for the number of followup submissions) by 790
requirements concerning the use of submissions to FDA during 2011, 2012, physicians for an average of 3.03
Form FDA 3926 for certain followup and 2013, we originally estimated that responses per respondent. FDA
reports are provided under §§ 312.32(c), approximately 790 licensed physicians estimates the average burden per
312.32(d), 312.33, 312.310(c)(2), 312.30, would use Form 3926 to submit 1.46 response to be 45 minutes (0.75 hour).
312.41, and 312.42(e). requests per physician (respondent) for Based on this estimate, FDA calculates
The estimates for ‘‘number of individual patient expanded access, for the total burden to be 1,795 hours.
respondents,’’ ‘‘number of responses per a total of 1,153 responses annually. In Under OMB control number 0910–0014,
respondent,’’ and ‘‘total annual response to comments received, FDA FDA currently has OMB approval of
responses’’ were obtained from the clarifies in the final guidance and in the 17,592 hours for these submissions. The
Center for Drug Evaluation and Research form instructions that licensed use of FDA Form 3926 will reduce the
(CDER) reports and data management physicians may also use Form FDA current burden by 15,797 hours.
systems and from other sources familiar 3926 for certain followup submissions. FDA estimates the burden of this
with the number of submissions Based on data for the number of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Guidance on individual patient expanded access Number of Total annual
responses per burden per Total hours
applications: Form FDA 3926 respondents responses
respondent response
Expanded access submission for treatment of an indi- 790 3.03 2,394 0.75 (45 min- 1,795
vidual patient, including submission of Form FDA 3926. utes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 8, 2016. including each proposed extension of an www.regulations.gov will be posted to
Leslie Kux, existing collection of information, and the docket unchanged. Because your
Associate Commissioner for Policy. to allow 60 days for public comment in comment will be made public, you are
[FR Doc. 2016–05491 Filed 3–10–16; 8:45 am] response to the notice. This notice solely responsible for ensuring that your
BILLING CODE 4164–01–P
invites comments on the information comment does not include any
collection provisions of the regulation confidential information that you or a
requiring the manufacturer, packer, or third party may not wish to be posted,
DEPARTMENT OF HEALTH AND distributor of a dietary supplement to such as medical information, your or
HUMAN SERVICES notify us that it is marketing a dietary anyone else’s Social Security number, or
supplement product that bears on its confidential business information, such
Food and Drug Administration label or in its labeling a statement as a manufacturing process. Please note
provided for in the Federal Food, Drug, that if you include your name, contact
[Docket No. FDA–2009–N–0221] and Cosmetic Act (the FD&C Act). The information, or other information that
notice also invites comment on a new identifies you in the body of your
Agency Information Collection
electronic form that allows comments, that information will be
Activities; Proposed Collection;
manufacturers, packers, and distributors posted on http://www.regulations.gov.
Comment Request; Food Labeling;
of dietary supplements to notify us via • If you want to submit a comment
Notification Procedures for Statements
FDA’s Unified Registration and Listing with confidential information that you
on Dietary Supplements
System (FURLS). do not wish to be made available to the
AGENCY: Food and Drug Administration, DATES: Submit either electronic or public, submit the comment as a
HHS. written comments on the collection of written/paper submission and in the
ACTION: Notice. information by May 10, 2016. manner detailed (see ‘‘Written/Paper
ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug as follows:
Administration (FDA or we) is Written/Paper Submissions
asabaliauskas on DSK3SPTVN1PROD with NOTICES
announcing an opportunity for public Electronic Submissions
comment on the proposed collection of Submit electronic comments in the Submit written/paper submissions as
certain information by the Agency. following way: follows:
Under the Paperwork Reduction Act of • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for
1995 (the PRA), Federal Agencies are www.regulations.gov. Follow the written/paper submissions): Division of
required to publish notice in the instructions for submitting comments. Dockets Management (HFA–305), Food
Federal Register concerning each Comments submitted electronically, and Drug Administration, 5630 Fishers
proposed collection of information, including attachments, to http:// Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1](https://thefederalregister.org/doc/81_FR_12958/page/1.svg)
![12912 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR section responses per Total hours
respondents responses response
respondent
101.93 .................................................................. 2,200 1 2,200 0.75 (45 minutes) .......... 1,650
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal competence of individual investigators, following points: (1) Whether the
burden on the industry to generate the disclosure of which would proposed collection of information is
information to meet the notification constitute a clearly unwarranted necessary for the proper performance of
requirements of section 403(r)(6) of the invasion of personal privacy. the function of the agency, including
FD&C Act by submitting information Name of Committee: Division of Intramural whether the information will have
regarding section 403(r)(6) of the FD&C Research Board of Scientific Counselors, practical utility; (2) The accuracy of the
Act statements on labels or in labeling NIAID. agency’s estimate of the burden of the
of dietary supplements. We also believe Date: June 6–7, 2016. proposed collection of information,
that submission via FURLS will not Time: 7:30 a.m. to 10:30 a.m. including the validity of the
affect the burden estimates. We are Agenda: To review and evaluate personal methodology and assumptions used; (3)
requesting only information that is qualifications and performance, and Ways to enhance the quality, utility, and
competence of individual investigators.
immediately available to the Place: National Institutes of Health,
clarity of the information to be
manufacturer, packer, or distributor of Building 50, Rooms 1227 and 1223, 50 Center collected; and (4) Ways to minimize the
the dietary supplement that bears such Drive, Rockville, MD 20852. burden of the collection of information
a statement on its label or in its labeling. Contact Person: Hugh J. Auchincloss, MD, on those who are to respond, including
We estimate that, each year, Deputy Director, NIAID Deputy Director, the use of appropriate automated,
approximately 2,200 firms will submit National Inst. of Allergy and Infectious electronic, mechanical, or other
the information required by section Diseases, National Institutes of Health, technological collection techniques or
403(r)(6) of the FD&C Act. This estimate Building 31, Room 7A03, MSC 2520, other forms of information technology.
Bethesda, MD 20892–2520, 301–496–9677, To Submit Comments and For Further
is based on the average number of
auchinclossh@niaid.nih.gov.
notification submissions received by us Information: To obtain a copy of the
(Catalogue of Federal Domestic Assistance data collection plans and instruments,
in the preceding 3 years. We estimate
Program Nos. 93.855, Allergy, Immunology,
that a firm will require 0.75 hours to submit comments in writing, or request
and Transplantation Research; 93.856,
gather the information needed and Microbiology and Infectious Diseases more information on the proposed
prepare a communication to us, for a Research, National Institutes of Health, HHS) project, contact: Steve Simon, Dosimetry
total of 1,650 hours (2,200 × 0.75). Unit Head and Staff Scientist, Radiation
Dated: March 7, 2016.
Dated: March 7, 2016.
Epidemiology Branch, Division of
Natasha M. Copeland, Cancer Epidemiology & Genetics,
Leslie Kux, Program Analyst, Office of Federal Advisory National Cancer Institute, NIH, 9609
Associate Commissioner for Policy. Committee Policy. Medical Center Drive, MSC9778,
[FR Doc. 2016–05478 Filed 3–10–16; 8:45 am] [FR Doc. 2016–05429 Filed 3–10–16; 8:45 am] Bethesda, MD 20892–9778 or call non-
BILLING CODE 4164–01–P BILLING CODE 4140–01–P toll-free number (240)-276–7371 or
Email your request, including your
address to: ssimon@mail.nih.gov.
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Formal requests for additional plans and
HUMAN SERVICES HUMAN SERVICES instruments must be requested in
National Institutes of Health writing.
National Institutes of Health Comment Due Date: Comments
National Institute of Allergy and Proposed Collection; 60-Day Comment regarding this information collection are
Infectious Diseases; Notice of Closed Request; Study To Estimate Radiation best assured of having their full effect if
Meeting Doses and Cancer Risks From received within 60 days of the date of
Radioactive Fallout From the Trinity this publication.
Pursuant to section 10(d) of the Proposed Collection: Study to
Nuclear Test—National Cancer
Federal Advisory Committee Act, as Estimate Radiation Doses and Cancer
Institute (NCI)
amended (5 U.S.C. App.), notice is Risks from Radioactive Fallout from the
hereby given of a meeting of the Summary: In compliance with the Trinity Nuclear Test, 0925–NEW, New
Division of Intramural Research Board requirement of Section 3506(c)(2)(A) of Submission, National Cancer Institute
of Scientific Counselors, NIAID. the Paperwork Reduction Act of 1995, (NCI), National Institutes of Health
The meeting will be closed to the for opportunity for public comment on (NIH).
public as indicated below in accordance proposed data collection projects, the Need and Use of Information
with the provisions set forth in section National Cancer Institute, the National Collection: This research plan is for a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
552b(c)(6), Title 5 U.S.C., as amended Institutes of Health (NIH) will publish radiation-related cancer risk projection
for the review, discussion, and periodic summaries of proposed study for the residents of the state of
evaluation of individual intramural projects to be submitted to the Office of New Mexico (NM) potentially exposed
programs and projects conducted by the Management and Budget (OMB) for to radioactive fallout from the Trinity
NATIONAL INSTITUTE OF ALLERGY review and approval. nuclear test conducted in 1945. Data
AND INFECTIOUS DISEASES, Written comments and/or suggestions will be collected on diet and lifestyle
including consideration of personnel from the public and affected agencies from three groups in NM (non-Hispanic
qualifications and performance, and the are invited to address one or more of the white, Hispanic, and Native American)
VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1](https://thefederalregister.org/doc/81_FR_12958/page/3.svg)
Document Created: 2016-03-11 01:51:06
Document Modified: 2016-03-11 01:51:06
| 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 May 10, 2016. | |
| FR Citation | 81 FR 12910 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR