81 FR 61700 - Request for Comment on the Status of Vinpocetine
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 173 (September 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 173 (September 7, 2016)
| Page Range | 61700-61703 | |
| FR Document | 2016-21350 |
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)] [Notices] [Pages 61700-61703] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21350] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2523] Request for Comment on the Status of Vinpocetine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding. DATES: Submit either electronic or written comments on the notice by November 7, 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 [[Page 61701]] 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-2016-N-2523 for ``Request for Comment on the Status of Vinpocetine.'' 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: Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2333. SUPPLEMENTARY INFORMATION: I. Introduction We are initiating an administrative proceeding under 21 CFR 10.25(b) to determine the regulatory status of vinpocetine (chemical name: Ethyl apovincaminate). Specifically, we are trying to determine: (1) Whether vinpocetine is a dietary ingredient within the meaning of the FD&C Act and (2) whether it is excluded from being a dietary supplement under the FD&C Act. A. Statutory Background Under section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)), the term ``dietary supplement'' is defined in part as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) A vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E). Additionally, under section 201(ff)(3)(B)(ii) of the FD&C Act, a dietary supplement cannot include ``an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public'' unless the article was marketed as a dietary supplement or as a food before such authorization. Recently, questions have been raised as to whether vinpocetine is a dietary ingredient and is excluded from the definition of dietary supplement under sections 201(ff)(1) and (3) of the FD&C Act, respectively. B. Factual Background According to records on file in FDA's Center for Drug Evaluation and Research, vinpocetine was authorized for investigation as a new drug in 1981.\1\ A trade press article from 1985 reported that four single-center phase 3 clinical trials \2\ of vinpocetine had been completed and that two major multicenter studies were ongoing (Ref. 1). A 1986 article in a major newspaper reported that Ayerst had recently completed a study of vinpocetine for the treatment of multiple-infarct dementia at eight institutions in the United States (Ref. 2). An article published in a medical journal in 1986 reported on the results of a double-blind study of vinpocetine in elderly patients with central nervous system degenerative disorders (Ref. 3). A trade press article published in 1988 reported that vinpocetine was in phase 3 clinical trials for Alzheimer's disease (Ref. 4). These articles document that substantial clinical investigations of vinpocetine were instituted and that the existence of these substantial clinical investigations was made public. --------------------------------------------------------------------------- \1\ An article becomes ``authorized for investigation as a new drug'' after the sponsor has submitted an investigational new drug application (IND) to FDA and the IND has gone into effect. Unless FDA notifies the sponsor that the clinical investigation described in the IND has been placed on clinical hold, the IND goes into effect 30 days after being submitted to FDA (21 CFR 312.40(b)). Although FDA will not disclose the existence of an IND that has not previously been publicly disclosed or acknowledged (see 21 CFR 312.130), the existence of the 1981 IND for vinpocetine was publicly disclosed in the press no later than 1986 (Ref. 2). \2\ Generally speaking, under our regulations pertaining to investigational new drugs, there are three phases of a clinical investigation of a new drug; phase 3 trials are the last in the sequence and are ``expanded controlled and uncontrolled trials'' that are ``performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling'' (21 CFR 312.21(c)). --------------------------------------------------------------------------- On July 8, 1997, a new dietary ingredient notification \3\ for vinpocetine was submitted to FDA (see FDA's Table of New Dietary Ingredient Notifications [[Page 61702]] (available on the Web at http://www.fda.gov/food/dietarysupplements/newdietaryingredientsnotificationprocess/ucm109764.htm#new_din)). Four additional new dietary ingredient notifications for vinpocetine were later submitted to FDA.\4\ --------------------------------------------------------------------------- \3\ As defined in section 413(d) of the FD&C Act (21 U.S.C. 350b(d)), the term ``new dietary ingredient'' means a dietary ingredient that was not marketed in the United States before October 15, 1994. Section 413(a) of the FD&C Act (21 U.S.C. 350b(a)) requires manufacturers and distributors who wish to market dietary supplements that contain ``new dietary ingredients'' to submit a notification containing safety information to FDA before they begin marketing, unless the new dietary ingredient and all other dietary ingredients in the dietary supplement have been present in the food supply, without chemical alteration, as articles used for food. \4\ We acknowledged receipt of each of those new dietary ingredient notifications without objection. --------------------------------------------------------------------------- C. Vinpocetine and Section 201(ff)(1) of the FD&C Act We first consider whether vinpocetine is a dietary ingredient under section 201(ff)(1) of the FD&C Act--specifically, whether it is a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of dietary ingredients from the preceding categories. We are not aware of any argument that vinpocetine is a vitamin, a mineral, or an amino acid. Thus, vinpocetine does not appear to qualify as a dietary ingredient under section 201(ff)(1)(A), (B), or (D) of the FD&C Act. Vinpocetine is not an herb or other botanical, nor is it a constituent of any botanical. Rather, vinpocetine is a synthetic compound, derived from vincamine, an alkaloid found in the Vinca minor plant, or tabersonine, an alkaloid found in Voacanga seeds (Ref. 5). Vinpocetine can be formed synthetically from vincamine, including via a ``one-pot'' synthesis, through transesterification and/or dehydration of vincamine in ethanol using Lewis acids and catalyzed by ferric chloride (Refs. 5 and 6). The process to prepare vinpocetine from tabersonine involves first converting to vincamine via hydrogenation, oxidation, reduction and, finally, isolation of vincamine (Ref. 7). The previously discussed method of producing vinpocetine from vincamine can then be used. As a synthetic compound, vinpocetine is not an herb or other botanical. Thus, vinpocetine does not appear to qualify as a dietary ingredient under section 201(ff)(1)(C) of the FD&C Act. Vinpocetine is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Extensive database and literature searches did not identify any food use of vinpocetine. Thus, vinpocetine does not appear to qualify as a dietary ingredient under section 201(ff)(1)(E) of the FD&C Act. Finally, vinpocetine is not a concentrate, metabolite, constituent, extract, or combination of any ingredient described in section 201(ff)(1)(A), (B), (C), (D), or (E) of the FD&C Act. We are not aware of any factual basis to conclude that vinpocetine is a concentrate, metabolite, constituent, extract, or combination of a vitamin, mineral, amino acid, or dietary substance. As described earlier, vinpocetine is not found in V. minor, Voacanga, or any other botanical, but rather is a synthetic derivative of vincamine or tabersonine. Therefore, vinpocetine cannot be a concentrate, constituent, or extract of a botanical. After extensive literature and database searches, we have been unable to find any evidence that vinpocetine is a concentrate, metabolite, constituent, extract, or combination of another dietary ingredient or dietary ingredients. Therefore, vinpocetine does not appear to qualify as a dietary ingredient under section 201(ff)(1)(F) of the FD&C Act. We therefore tentatively conclude that vinpocetine is not a dietary ingredient under section 201(ff)(1) of the FD&C Act because it does not fit any of the dietary ingredient categories. D. Vinpocetine and Section 201(ff)(3) of the FD&C Act As noted above, the statutory definition of ``dietary supplement'' excludes an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or as a food before such authorization (see section 201(ff)(3)(B)(ii) of the FD&C Act). Based on FDA's IND records and articles published between 1985 and 1988 that mention or report on phase 3 clinical trials for vinpocetine (Refs. 1 to 4), it appears that: (1) Vinpocetine was authorized for investigation as a new drug in 1981, long before the first new dietary ingredient notification for vinpocetine was filed in 1997 and, therefore, also long before vinpocetine was marketed as a dietary supplement; (2) substantial clinical investigations of vinpocetine have been instituted, and (3) the existence of such investigations has been made public. We therefore tentatively conclude that vinpocetine is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. E. Tentative Conclusion Based on the evidence available to us to date, we tentatively conclude that vinpocetine is not a dietary ingredient as defined in section 201(ff)(1) of the FD&C Act. We further tentatively conclude that vinpocetine is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act and therefore may not be marketed as or in a dietary supplement. We are interested in receiving information that would inform our final decision on the regulatory status of vinpocetine, such as information about any food uses of vinpocetine and information on the date vinpocetine was first marketed as a food or as a dietary supplement. To afford all interested parties an adequate opportunity to participate in this matter, we request comments and other supporting information related to this matter. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. II. References The following references are on display in FDA's Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. The Pink Sheet, ``Ayerst Planning on First Quarter 1986 NDA Submission for Alredase (Tolrestat) in Diabetic Neuropathy; Firm is Shooting for Early 1987 Market Launch,'' June 17, 1985. Retrieved from: https://pink.pharmamedtechbi.com/PS008480/AYERST-PLANNING-ON-FIRST-QUARTER-1986-NDA-SUBMISSION-FOR-ALREDASE-TOLRESTAT-IN-DIABETIC-NEUROPATHY-F. 2. Maugh II, T. H., ``Firm Hopes to Market New `Memory' Drug,'' The Los Angeles Times, April 15, 1986. Retrieved from: http://articles.latimes.com/1986-04-15/news/mn-4847_1_vinpocetine. 3. Manconi, E., F. Binaghi, and F. Pitzus, ``A Double-Blind Clinical Trial of Vinpocetine in the Treatment of Cerebral Insufficiency of Vascular and Degenerative Origin,'' Current Therapeutic Research, Vol. 40, No. 4, 1986. 4. The Pink Sheet, ``American Home Products' `Third Generation' TPA Entering Clinicals,'' March 21, 1988. Retrieved from: https://pink.pharmamedtechbi.com/PS013359/AMERICAN-HOME-PRODUCTS-THIRD-GENERATION-TPA-ENTERING-CLINICALS. 5. National Toxicology Program, U.S. Dept. of Health and Human Services, ``Chemical Information Review Document for Vinpocetine [CAS No. 42971-09-5].'' Retrieved from: http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/vinpocetine091613_508.pdf. 6. Y. Kuge, H. Nakazawa, T. Kometani, et al., ``A Facile One-Pot Synthesis of Vinpocetine,'' Synthetic Communications: [[Page 61703]] An Internal Journal for Rapid Communication of Synthetic Organic Chemistry, vol. 24, no. 6, 1994. 7. U.S. Patent and Trademark Office, ``Process of Preparation of Vincamine from Tabersonine.'' Retrieved from: http://www.google.com/patents/US3892755. Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21350 Filed 9-6-16; 8:45 am] BILLING CODE 4164-01-P
![61702 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
(available on the Web at http:// ingredient described in section under section 201(ff)(3)(B) of the FD&C
www.fda.gov/food/dietarysupplements/ 201(ff)(1)(A), (B), (C), (D), or (E) of the Act and therefore may not be marketed
newdietaryingredients FD&C Act. We are not aware of any as or in a dietary supplement. We are
notificationprocess/ factual basis to conclude that interested in receiving information that
ucm109764.htm#new_din)). Four vinpocetine is a concentrate, metabolite, would inform our final decision on the
additional new dietary ingredient constituent, extract, or combination of a regulatory status of vinpocetine, such as
notifications for vinpocetine were later vitamin, mineral, amino acid, or dietary information about any food uses of
submitted to FDA.4 substance. As described earlier, vinpocetine and information on the date
vinpocetine is not found in V. minor, vinpocetine was first marketed as a food
C. Vinpocetine and Section 201(ff)(1) of
Voacanga, or any other botanical, but or as a dietary supplement.
the FD&C Act
rather is a synthetic derivative of To afford all interested parties an
We first consider whether vinpocetine vincamine or tabersonine. Therefore, adequate opportunity to participate in
is a dietary ingredient under section vinpocetine cannot be a concentrate, this matter, we request comments and
201(ff)(1) of the FD&C Act—specifically, constituent, or extract of a botanical. other supporting information related to
whether it is a vitamin, mineral, herb or After extensive literature and database this matter. Interested persons may
other botanical, amino acid, dietary searches, we have been unable to find submit to the Division of Dockets
substance for use by man to supplement any evidence that vinpocetine is a Management (see ADDRESSES) written or
the diet by increasing the total dietary concentrate, metabolite, constituent, electronic comments regarding this
intake, or a concentrate, metabolite, extract, or combination of another document.
constituent, extract, or combination of dietary ingredient or dietary ingredients.
dietary ingredients from the preceding Therefore, vinpocetine does not appear II. References
categories. We are not aware of any to qualify as a dietary ingredient under The following references are on
argument that vinpocetine is a vitamin, section 201(ff)(1)(F) of the FD&C Act. display in FDA’s Division of Dockets
a mineral, or an amino acid. Thus, We therefore tentatively conclude that Management (see ADDRESSES) and are
vinpocetine does not appear to qualify vinpocetine is not a dietary ingredient available for viewing by interested
as a dietary ingredient under section under section 201(ff)(1) of the FD&C Act persons between 9 a.m. and 4 p.m.,
201(ff)(1)(A), (B), or (D) of the FD&C because it does not fit any of the dietary Monday through Friday; they are also
Act. ingredient categories. available electronically at http://
Vinpocetine is not an herb or other www.regulations.gov. FDA has verified
botanical, nor is it a constituent of any D. Vinpocetine and Section 201(ff)(3) of
the Web site addresses, as of the date
botanical. Rather, vinpocetine is a the FD&C Act
this document publishes in the Federal
synthetic compound, derived from As noted above, the statutory Register, but Web sites are subject to
vincamine, an alkaloid found in the definition of ‘‘dietary supplement’’ change over time.
Vinca minor plant, or tabersonine, an excludes an article authorized for
1. The Pink Sheet, ‘‘Ayerst Planning on First
alkaloid found in Voacanga seeds (Ref. investigation as a new drug for which Quarter 1986 NDA Submission for
5). Vinpocetine can be formed substantial clinical investigations have Alredase (Tolrestat) in Diabetic
synthetically from vincamine, including been instituted and made public, unless Neuropathy; Firm is Shooting for Early
via a ‘‘one-pot’’ synthesis, through the article was marketed as a dietary 1987 Market Launch,’’ June 17, 1985.
transesterification and/or dehydration of supplement or as a food before such Retrieved from: https://
vincamine in ethanol using Lewis acids authorization (see section pink.pharmamedtechbi.com/PS008480/
and catalyzed by ferric chloride (Refs. 5 201(ff)(3)(B)(ii) of the FD&C Act). AYERST-PLANNING-ON-FIRST-
Based on FDA’s IND records and QUARTER-1986-NDA-SUBMISSION-FOR-
and 6). The process to prepare
articles published between 1985 and ALREDASE-TOLRESTAT-IN-DIABETIC-
vinpocetine from tabersonine involves NEUROPATHY-F.
first converting to vincamine via 1988 that mention or report on phase 3 2. Maugh II, T. H., ‘‘Firm Hopes to Market
hydrogenation, oxidation, reduction clinical trials for vinpocetine (Refs. 1 to New ‘Memory’ Drug,’’ The Los Angeles
and, finally, isolation of vincamine (Ref. 4), it appears that: (1) Vinpocetine was Times, April 15, 1986. Retrieved from:
7). The previously discussed method of authorized for investigation as a new http://articles.latimes.com/1986-04-15/
producing vinpocetine from vincamine drug in 1981, long before the first new news/mn-4847_1_vinpocetine.
can then be used. As a synthetic dietary ingredient notification for 3. Manconi, E., F. Binaghi, and F. Pitzus, ‘‘A
compound, vinpocetine is not an herb vinpocetine was filed in 1997 and, Double-Blind Clinical Trial of Vinpocetine
therefore, also long before vinpocetine in the Treatment of Cerebral Insufficiency
or other botanical. Thus, vinpocetine
was marketed as a dietary supplement; of Vascular and Degenerative Origin,’’
does not appear to qualify as a dietary Current Therapeutic Research, Vol. 40, No.
ingredient under section 201(ff)(1)(C) of (2) substantial clinical investigations of 4, 1986.
the FD&C Act. vinpocetine have been instituted, and 4. The Pink Sheet, ‘‘American Home
Vinpocetine is not a dietary substance (3) the existence of such investigations Products’ ‘Third Generation’ TPA Entering
for use by man to supplement the diet has been made public. Clinicals,’’ March 21, 1988. Retrieved from:
by increasing the total dietary intake. We therefore tentatively conclude that https://pink.pharmamedtechbi.com/
Extensive database and literature vinpocetine is excluded from the dietary PS013359/AMERICAN-HOME-PRODUCTS-
searches did not identify any food use supplement definition under section THIRD-GENERATION-TPA-ENTERING-
of vinpocetine. Thus, vinpocetine does 201(ff)(3)(B) of the FD&C Act. CLINICALS.
5. National Toxicology Program, U.S. Dept. of
not appear to qualify as a dietary E. Tentative Conclusion Health and Human Services, ‘‘Chemical
mstockstill on DSK3G9T082PROD with NOTICES
ingredient under section 201(ff)(1)(E) of Information Review Document for
the FD&C Act. Based on the evidence available to us
to date, we tentatively conclude that Vinpocetine [CAS No. 42971–09–5].’’
Finally, vinpocetine is not a Retrieved from: http://ntp.niehs.nih.gov/
concentrate, metabolite, constituent, vinpocetine is not a dietary ingredient ntp/htdocs/chem_background/exsumpdf/
extract, or combination of any as defined in section 201(ff)(1) of the vinpocetine091613_508.pdf.
FD&C Act. We further tentatively 6. Y. Kuge, H. Nakazawa, T. Kometani, et al.,
4 We acknowledged receipt of each of those new conclude that vinpocetine is excluded ‘‘A Facile One-Pot Synthesis of
dietary ingredient notifications without objection. from the dietary supplement definition Vinpocetine,’’ Synthetic Communications:
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![Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61703
An Internal Journal for Rapid Request (ICR), described below, to the and Budget (OMB) approval on a new
Communication of Synthetic Organic Office of Management and Budget (ICR). This survey is being conducted to
Chemistry, vol. 24, no. 6, 1994. (OMB). Prior to submitting the ICR to generate national estimates of recovery
7. U.S. Patent and Trademark Office,
‘‘Process of Preparation of Vincamine from
OMB, OS seeks comments from the through utilization activity; of donated
Tabersonine.’’ Retrieved from: http:// public regarding the burden estimate human tissue for calendar years 2012
www.google.com/patents/US3892755. below or any other aspect of the ICR. and 2015, and to compare metrics across
Prior to submitting the ICR to OMB, OS three data collection periods that
Dated: August 31, 2016. seeks comments from the public includes results from a 2007 survey, the
Leslie Kux, regarding the burden estimate, below, or most recent year these data were
Associate Commissioner for Policy. any other aspect of the ICR. collected. The survey and data
[FR Doc. 2016–21350 Filed 9–6–16; 8:45 am] DATES: Comments on the ICR must be collection and analysis methods will be
BILLING CODE 4164–01–P received on or before [November 7, similar to the 2007 survey. The general
2016]. categories of information to be collected
ADDRESSES: Submit your comments to are listed under the Survey Section of
DEPARTMENT OF HEALTH AND the Annualized Burden Hour table
HUMAN SERVICES Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162. below. Policy advice provided by the
Office of the Secretary FOR FURTHER INFORMATION CONTACT:
HHS Advisory Committee on Blood and
Information Collection Clearance staff, Tissue Safety and Availability to the
[Document Identifier: HHS–OS–0990–new– HHS Secretary and Assistant Secretary
60D] Information.CollectionClearance@
hhs.gov or (202) 690–6162. for Health is used to direct departmental
Agency Information Collection efforts to address transfusion and
SUPPLEMENTARY INFORMATION: When
Activities; Proposed Collection; Public transplantation issues; such as
submitting comments or requesting
Comment Request emergency preparedness and infectious
information, please include the
document identifier HHS–OS–0990– disease transmission related to donated
AGENCY: Office of the Secretary, HHS. human tissue.
ACTION: Notice. new–60D for reference.
Information Collection Request Title: Likely Respondents: Respondents for
SUMMARY: In compliance with section National Tissue Recovery through this survey would be U.S. tissue banks
3506(c)(2)(A) of the Paperwork Utilization Survey. that screen and recover tissue from
Reduction Act of 1995, the Office of the Abstract: Office of HIV/AIDS and living and deceased donors, and
Secretary (OS), Department of Health Infectious Disease Policy, Office of the process, store, and/or distribute tissues
and Human Services, announces plans Assistant Secretary for Health, grafts for transplantation from these
to submit a new Information Collection requesting the Office of Management donors.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Survey section Type of respondent respondents per response hours
respondent (in hours)
Tissue bank activities, tissue types All tissue banks ................................ 110 5 5/60 46
handled, and inspections.
Referrals, authorization, and in- Tissue banks that handle referrals, 80 36 30/60 1440
formed consent; tissue recovery Recover/acquire tissue.
and acquisition.
Tissue processing ............................. Tissue banks that process tissue .... 35 17 30/60 298
Tissue storage .................................. Tissue banks that store tissue ......... 65 4 10/60 5
Tissue distribution ............................. Tissue banks that distribute tissue .. 58 16 15/60 232
Communicable disease testing and Tissue banks that have donor infec- 35 4 30/60 70
adverse outcome reports. tious disease testing performed
and may handle adverse outcome
reports.
Total ........................................... ........................................................... ........................ ........................ ........................ 2091
OS specifically requests comments on technology to minimize the information DEPARTMENT OF HEALTH AND
(1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Terry S. Clark, Indian Health Service
proper performance of the agency’s
functions, (2) the accuracy of the Asst Information Collection Clearance
Officer. Notice of Office of Urban Indian Health
estimated burden, (3) ways to enhance
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–21360 Filed 9–6–16; 8:45 am] Programs Strategic Plan
the quality, utility, and clarity of the
information to be collected, and (4) the BILLING CODE 4150–28–P
AGENCY: Indian Health Service,
use of automated collection techniques Department of Health and Human
or other forms of information Services.
Notice and request for
ACTION:
comments.
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Document Created: 2016-09-07 11:50:58
Document Modified: 2016-09-07 11:50:58
| 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 notice by November 7, 2016. | |
| Contact | Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2333. | |
| FR Citation | 81 FR 61700 |
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