82 FR 51425 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 213 (November 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 213 (November 6, 2017)
| Page Range | 51425-51427 | |
| FR Document | 2017-24123 |
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)] [Notices] [Pages 51425-51427] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24123] [[Page 51425]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0403] Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' DATES: Submit either electronic or written comments on the collection of information by January 5, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 5, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 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-2011-N-0403 for ``Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.'' 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 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. FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. [[Page 51426]] 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. Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act--21 U.S.C. 343(r)(6) OMB Control Number 0910-0626--Extension This information collection supports Agency regulations and associated guidance. Specifically, section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. A nutritional deficiency claim states a benefit related to a classical nutrient deficiency disease and states how often the disease occurs in the United States. A structure/function claim describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or characterizes how a nutrient or dietary ingredient acts to maintain such structure or function. A general well-being claim describes general well-being from consumption of a nutrient or dietary ingredient. The guidance document entitled ``Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act'' provides our recommendations to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6) of the FD&C Act. The guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. The guidance document is intended to assist manufacturers in their efforts to comply with section 403(r)(6) of the FD&C Act. Persons with access to the internet may obtain the guidance at https://www.fda.gov/FoodGuidances. Dietary supplement manufacturers collect the necessary substantiating information for their product as required by section 403(r)(6) of the FD&C Act. The guidance provides information to manufacturers to assist them in doing so. The recommendations contained in the guidance are voluntary. Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they choose to place a claim on their product's label. The standard discussed in the guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health-related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature. The time it takes to assemble the necessary scientific information to support their claims depends on the product and the claimed benefits. If the product is one of several on the market making a particular claim for which there is adequate publicly available and widely established evidence supporting the claim, then the time to gather supporting data will be minimal; if the product is the first of its kind to make a particular claim or the evidence supporting the claim is less publicly available or not widely established, then gathering the appropriate scientific evidence to substantiate the claim will be more time consuming. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Claim type Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Widely known, established....... 667 1 667 44 29,348 Preexisting, not widely 667 1 667 120 80,040 established.................... Novel........................... 667 1 667 120 80,040 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 189,428 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We have retained the currently approved burden estimate for the information collection. Based on our experience with the collection, we estimate that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established. We believe it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is preexisting but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals and in foreign languages or in the older, classical literature where it is not available on computerized literature databases or in the major scientific reference databases, such as the National Library of Medicine's literature database, all of which increases the time of obtaining substantiation. [[Page 51427]] In the Federal Register of January 6, 2000 (65 FR 1000), we published a final rule (the `structure/function final rule) on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. In that final rule, we estimated that there were 29,000 dietary supplement products marketed in the United States (65 FR 1000 at 1045). Assuming that the flow of new products is 10 percent per year, then 2,900 new dietary supplement products will come on the market each year. The structure/ function final rule estimated that about 69 percent of dietary supplements have a claim on their labels, most probably a structure/ function claim (65 FR 1000 at 1046). Therefore, we assume that supplement manufacturers will need time to assemble the evidence to substantiate each of the 2,001 claims (2,900 x 69 percent) made each year. If we assume that the 2,001 claims are equally likely to be preexisting widely established claims, novel claims, or preexisting claims that are not widely established, then we can expect 667 of each of these types of claims to be substantiated per year. Table 1 of this document shows that the annual burden hours associated with assembling evidence for claims is 189,428 (the sum of 667 x 44 hours, 667 x 120 hours, and 667 x 120 hours). Dated: October 31, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24123 Filed 11-3-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51425
DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available
HUMAN SERVICES comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
[Docket No. FDA–2011–N–0403]
third party may not wish to be posted, contact information to be made publicly
Agency Information Collection such as medical information, your or available, you can provide this
Activities; Proposed Collection; anyone else’s Social Security number, or information on the cover sheet and not
Comment Request; Substantiation for confidential business information, such in the body of your comments and you
Dietary Supplement Claims Made as a manufacturing process. Please note
must identify this information as
Under the Federal Food, Drug, and that if you include your name, contact
‘‘confidential.’’ Any information marked
Cosmetic Act information, or other information that
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
comments, that information will be except in accordance with 21 CFR 10.20
AGENCY: Food and Drug Administration,
HHS. posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
ACTION: Notice. of comments to public dockets, see 80
with confidential information that you
SUMMARY: The Food and Drug do not wish to be made available to the FR 56469, September 18, 2015, or access
Administration (FDA or Agency) is public, submit the comment as a the information at: https://www.gpo.gov/
announcing an opportunity for public written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
comment on the proposed collection of manner detailed (see ‘‘Written/Paper 23389.pdf.
certain information by the Agency. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Under the Paperwork Reduction Act of Written/Paper Submissions read background documents or the
1995 (PRA), Federal Agencies are electronic and written/paper comments
required to publish notice in the Submit written/paper submissions as
follows: received, go to https://
Federal Register concerning each www.regulations.gov and insert the
proposed collection of information, • Mail/Hand delivery/Courier (for
written/paper submissions): Dockets docket number, found in brackets in the
including each proposed extension of an heading of this document, into the
existing collection of information, and Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
to allow 60 days for public comment in
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
response to the notice. This notice
solicits comments on the information • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management Rockville, MD 20852.
collection provisions of the Federal
Food, Drug, and Cosmetic Act (the Staff, FDA will post your comment, as
well as any attachments, except for FOR FURTHER INFORMATION CONTACT: Ila
FD&C Act) and the guidance entitled Mizrachi, Office of Operations, Food
information submitted, marked and
‘‘Guidance for Industry: Substantiation and Drug Administration, Three White
identified, as confidential, if submitted
for Dietary Supplement Claims Made Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Under Section 403(r)(6) of the Federal Landsdown St., North Bethesda, MD
Instructions: All submissions received
Food, Drug, and Cosmetic Act.’’ 20852, 301–796–7726, PRAStaff@
must include the Docket No. FDA–
DATES: Submit either electronic or 2011–N–0403 for ‘‘Substantiation for fda.hhs.gov.
written comments on the collection of Dietary Supplement Claims Made Under
information by January 5, 2018. the Federal Food, Drug, and Cosmetic SUPPLEMENTARY INFORMATION: Under the
ADDRESSES: You may submit comments Act.’’ Received comments, those filed in PRA (44 U.S.C. 3501–3520), Federal
as follows. Please note that late, a timely manner (see ADDRESSES), will Agencies must obtain approval from the
untimely filed comments will not be be placed in the docket and, except for Office of Management and Budget
considered. Electronic comments must those submitted as ‘‘Confidential (OMB) for each collection of
be submitted on or before January 5, Submissions,’’ publicly viewable at information they conduct or sponsor.
2018. The https://www.regulations.gov https://www.regulations.gov or at the ‘‘Collection of information’’ is defined
electronic filing system will accept Dockets Management Staff between 9 in 44 U.S.C. 3502(3) and 5 CFR
comments until midnight Eastern Time a.m. and 4 p.m., Monday through 1320.3(c) and includes Agency requests
at the end of January 5, 2018. Comments Friday. or requirements that members of the
received by mail/hand delivery/courier • Confidential Submissions—To public submit reports, keep records, or
(for written/paper submissions) will be submit a comment with confidential provide information to a third party.
considered timely if they are information that you do not wish to be Section 3506(c)(2)(A) of the PRA (44
postmarked or the delivery service made publicly available, submit your U.S.C. 3506(c)(2)(A)) requires Federal
acceptance receipt is on or before that comments only as a written/paper Agencies to provide a 60-day notice in
date. submission. You should submit two the Federal Register concerning each
copies total. One copy will include the proposed collection of information,
Electronic Submissions
information you claim to be confidential including each proposed extension of an
Pmangrum on DSK3GDR082PROD with NOTICES
Submit electronic comments in the with a heading or cover note that states existing collection of information,
following way: ‘‘THIS DOCUMENT CONTAINS before submitting the collection to OMB
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The for approval. To comply with this
https://www.regulations.gov. Follow the Agency will review this copy, including
requirement, FDA is publishing notice
instructions for submitting comments. the claimed confidential information, in
of the proposed collection of
Comments submitted electronically, its consideration of comments. The
information set forth in this document.
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
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![Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51427
In the Federal Register of January 6, Name of Committee: National Institute of Date: November 15, 2017.
2000 (65 FR 1000), we published a final Mental Health Special Emphasis Panel; Time: 10:00 a.m. to 11:00 a.m.
rule (the ‘structure/function final rule) NIMH HIV/AIDS Review (P30, T32). Agenda: To review and evaluate grant
Date: November 28, 2017. applications.
on statements made for dietary Time: 12:00 p.m. to 5:00 p.m. Place: National Institutes of Health, 6701
supplements concerning the effect of the Agenda: To review and evaluate grant Rockledge Drive, Bethesda, MD 20892
product on the structure or function of applications. (Telephone Conference Call).
the body. In that final rule, we estimated Place: National Institutes of Health Contact Person: Luis Espinoza, Ph.D.,
that there were 29,000 dietary Neuroscience Center, 6001 Executive Scientific Review Officer, Center for
supplement products marketed in the Boulevard, Rockville, MD 20852 (Virtual Scientific Review, National Institutes of
United States (65 FR 1000 at 1045). Meeting). Health, 6701 Rockledge Drive, Room 4140,
Contact Person: David W. Miller, Ph.D., MSC 7814, Bethesda, MD 20892, 301–435–
Assuming that the flow of new products
Scientific Review Officer, Division of 0952, espinozala@mail.nih.gov.
is 10 percent per year, then 2,900 new Extramural Activities, National Institute of
dietary supplement products will come Name of Committee: Center for Scientific
Mental Health, NIH, Neuroscience Center, Review Special Emphasis Panel; Member
on the market each year. The structure/ 6001 Executive Blvd, Room 6140, MSC 9608, Conflict: Neurological, Neuropsychological
function final rule estimated that about Bethesda, MD 20892–9608, 301–443–9734,
Disorders and Aging.
69 percent of dietary supplements have millerda@mail.nih.gov.
Date: November 17, 2017.
a claim on their labels, most probably a (Catalogue of Federal Domestic Assistance Time: 10:00 a.m. to 2:00 p.m.
structure/function claim (65 FR 1000 at Program No. 93.242, Mental Health Research Agenda: To review and evaluate grant
1046). Therefore, we assume that Grants; National Institutes of Health, HHS) applications.
supplement manufacturers will need Dated: October 31, 2017. Place: National Institutes of Health, 6701
time to assemble the evidence to Melanie J. Pantoja, Rockledge Drive, Bethesda, MD 20892
substantiate each of the 2,001 claims (Virtual Meeting).
Program Analyst, Office of Federal Advisory
Contact Person: Samuel C. Edwards, Ph.D.,
(2,900 × 69 percent) made each year. If Committee Policy.
Chief, Brain Disorders and Clinical
we assume that the 2,001 claims are [FR Doc. 2017–24034 Filed 11–3–17; 8:45 am] Neuroscience, Center for Scientific Review,
equally likely to be preexisting widely BILLING CODE 4140–01–P National Institutes of Health, 6701 Rockledge
established claims, novel claims, or Drive, Room 5210, MSC 7846, Bethesda, MD
preexisting claims that are not widely 20892, (301) 435–1246, edwardss@
established, then we can expect 667 of DEPARTMENT OF HEALTH AND csr.nih.gov.
each of these types of claims to be HUMAN SERVICES Name of Committee: Center for Scientific
substantiated per year. Table 1 of this Review Special Emphasis Panel; Member
document shows that the annual burden National Institutes of Health Conflict: AIDS and AIDS Related Research.
hours associated with assembling Date: November 28, 2017.
evidence for claims is 189,428 (the sum Center for Scientific Review; Notice of Time: 12:00 p.m. to 4:00 p.m.
of 667 × 44 hours, 667 × 120 hours, and Closed Meetings Agenda: To review and evaluate grant
applications.
667 × 120 hours). Pursuant to section 10(d) of the Place: National Institutes of Health, 6701
Dated: October 31, 2017. Federal Advisory Committee Act, as Rockledge Drive, Bethesda, MD 20892
Anna K. Abram, amended, notice is hereby given of the (Telephone Conference Call).
Deputy Commissioner for Policy, Planning,
following meetings. Contact Person: Mark P. Rubert, Ph.D.,
Legislation, and Analysis.
The meetings will be closed to the Scientific Review Officer, Center for
public in accordance with the Scientific Review, National Institutes of
[FR Doc. 2017–24123 Filed 11–3–17; 8:45 am] Health, 6701 Rockledge Drive, Room 5218,
provisions set forth in sections
BILLING CODE 4164–01–P
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7852, Bethesda, MD 20892, 301–435–
as amended. The grant applications and 1775, rubertm@csr.nih.gov.
the discussions could disclose Name of Committee: Center for Scientific
DEPARTMENT OF HEALTH AND Review Special Emphasis Panel; Small
confidential trade secrets or commercial
HUMAN SERVICES Business: Dermatology, Rheumatology and
property such as patentable material,
Inflammation.
National Institutes of Health and personal information concerning Date: November 29, 2017.
individuals associated with the grant Time: 10:30 a.m. to 5:30 p.m.
National Institute of Mental Health; applications, the disclosure of which Agenda: To review and evaluate grant
Notice of Closed Meeting would constitute a clearly unwarranted applications.
invasion of personal privacy. Place: National Institutes of Health, 6701
Pursuant to section 10(d) of the Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892.
Federal Advisory Committee Act, as Review Special Emphasis Panel; Small Contact Person: Rajiv Kumar, Ph.D., Chief,
amended, notice is hereby given of the Business: Respiratory Sciences. MOSS IRG, Center for Scientific Review,
Date: November 15–16, 2017. National Institutes of Health, 6701 Rockledge
following meeting.
Time: 8:00 a.m. to 5:00 p.m. Drive, Room 4216, MSC 7802, Bethesda, MD
The meeting will be closed to the Agenda: To review and evaluate grant 20892, 301–435–1212, kumarra@csr.nih.gov.
public in accordance with the applications. Name of Committee: Center for Scientific
provisions set forth in sections Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Small
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Rockledge Drive, Bethesda, MD 20892 Business: HIV/AIDS Innovative Research
as amended. The grant applications and (Virtual Meeting). Applications.
Pmangrum on DSK3GDR082PROD with NOTICES
the discussions could disclose Contact Person: Sara Ahlgren, Ph.D., Date: November 30, 2017.
confidential trade secrets or commercial Scientific Review Officer, Center for Time: 1:00 p.m. to 3:00 p.m.
Scientific Review, National Institutes of Agenda: To review and evaluate grant
property such as patentable material, Health, 6701 Rockledge Drive, RM 4136, applications.
and personal information concerning Bethesda, MD 20892, 301–435–0904, Place: National Institutes of Health, 6701
individuals associated with the grant sara.ahlgren@nih.gov. Rockledge Drive, Bethesda, MD 20892
applications, the disclosure of which Name of Committee: Center for Scientific (Virtual Meeting)
would constitute a clearly unwarranted Review Special Emphasis Panel; Blood Contact Person: Jose H. Guerrier, Ph.D.,
invasion of personal privacy. Disorders. Scientific Review Officer, Center for
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Document Created: 2017-11-07 10:30:24
Document Modified: 2017-11-07 10:30:24
| 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 January 5, 2018. | |
| Contact | Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 51425 |
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